protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02667457 | 8.5 | Premature Discontinuation | 8.5 Premature Discontinuation The withdrawal of a study participant is mandatory in the following cases: | A A A- A n n e xi n- 0 4 | | | P a g e 1 8 of 4 5 | |--------------------------|--|--|--------------------| | St u d y Pr ot o c ol | | | | - Pr e g n a n c y - Pr ot o c ol vi ol ati o n d et er mi n e d a s crit... | [] |
NCT02667457 | 8 | 6 Pr o hi biti o n s a n d R e stri cti o n s | 8. 6 Pr o hi biti o n s a n d R e stri cti o n s T h e m o st i m p ort a nt r e q uir e d r e stri cti o n f or st u d y p arti ci p a nt s i s pr e g n a n c y. I m a gi n g i s p erf or m e d a m b ul at or y. Aft er i m a gi n g, p arti ci p a nt m a y g o b a c k h o m e or g o b a c k t o w or k wit h o ut a n y ... | [] |
NCT02667457 | 9 | I n v e sti g ati o n al Pr o d u ct, D o s e a n d M o d e of A d mi ni str ati o n | 9. I n v e sti g ati o n al Pr o d u ct, D o s e a n d M o d e of A d mi ni str ati o n T h e f ull n a m e of t h e I n v e sti g ati o n al Dr u g i s " Kit f or t h e Pr e p ar ati o n of T c- 9 9 m R e c o m bi n a nt H u m a n A n n e xi n V- 1 2 8 f or I nj e cti o n". | [] |
NCT02667457 | 9 | 1 D e s cri pti o n of I n v e sti g ati o n al Pr o d u ct | 9. 1 D e s cri pti o n of I n v e sti g ati o n al Pr o d u ct T h e kit will b e pr e p ar e d, p a c k a g e d a n d r el e a s e d a c c or di n g t o t h e m a n uf a ct ur er' s St a n d ar d O p er ati n g Pr o c e d ur e s ( S O P s), a n d i n c o m pli a n c e wit h t h e pri n ci pl e s of t h e G o o d M a n... | [] |
NCT02667457 | 9.2 | Handling, Preparation and Storage | 9.2 Handling, Preparation and Storage The investigational product must be stored, handled and administered only by qualified/authorized personnel and must be prepared in accordance with pharmaceutical quality requirements, and radiation safety regulations. 99mTc-rhAnnexin V-128 must be administered at the investigation... | [] |
NCT02667457 | 9.3 | Investigational Product Accountability | 9.3 Investigational Product Accountability Drug inventory and accountability records for the "Kits for preparation of Technetium 99mTcrhAnnexin V-128 for injection" will be kept by the Investigator/radiopharmacist, and must be documented throughout the study. On an ongoing basis, the Investigator/radiopharmacist will c... | [] |
NCT02667457 | 9 | 4 I n v e sti g ati o n al Pr o d u ct D o s e, M o d e of A d mi ni str ati o n | 9. 4 I n v e sti g ati o n al Pr o d u ct D o s e, M o d e of A d mi ni str ati o n T h e " Kit f or pr e p ar ati o n of 9 9 m T c-r h A n n e xi n V- 1 2 8 f or i nj e cti o n" c o n si st s of 1 d o s e. P arti ci p a nt s will r e c ei v e o n e d o s e of 3 5 0 M B q ± 1 0 % of 9 9 m T c-r h A n n e xi n V- 1 2 8 ... | [
"1 0. St u d y Pr o c e d ur e s",
"1 0. 1 B a s eli n e A s s e s s m e nt s",
"1 0. 2 L a b or at or y A s s e s s m e nt s",
"1 0. 3 9 9 m T c-r h A n n e xi n V- 1 2 8 Pl a n ar a n d S P E C T I m a gi n g of t h e C ar oti d Art eri e s a n d A ort a a n d I m a g e A n al y si s"
] |
NCT02667457 | 10.4 | 99mTc-rhAnnexin V-128 Radiation Risk Assessment | 10.4 99mTc-rhAnnexin V-128 Radiation Risk Assessment Participants will receive radiation from 1) 99mTc-rhAnnexin V-128 (350 MBq) for a dose of 2.2 mSv (7.7 + 0.8 uSv/MBq) and 2) the CT scan for attenuation correction for a dose of 1.8 mSv. Total dose for 99mTc-rhAnnexin V-128 and CT components will be 4.0 mSv. | [] |
NCT02667457 | 10.5 | Ultrasound Examination | 10.5 Ultrasound Examination Clinical evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 10 years prior to enrolment is required for inclusion in the trial. Evidence of 50% or more carotid stenosis has to be confirmed in a more recent US imaging within 8 weeks prior to ... | [] |
NCT02667457 | 11 | Data Monitoring Committee | 11. Data Monitoring Committee The Data Monitoring Committee (DMC) consists of investigators and Sponsor representatives, as well as external persons such as independent experts, if deemed necessary by the Sponsor. The DMC will review and evaluate the images of the first 15 patients and the first 5 healthy participants ... | [] |
NCT02667457 | 12 | Statistical methods | 12. Statistical methods | [] |
NCT02667457 | 12.1 | Sample size and analysis | 12.1 Sample size and analysis The primary hypothesis is that 99mTc-rhAnnexin V-128 SPECT carotid imaging can detect apoptosis. We anticipate that the prevalence of positive 99mTc-rhAnnexin V-128 SPECT carotid scans will be about 0.3 to 0.5 of the patients. A sample size of 30 patients produces a 95% confidence interval... | [] |
NCT02667457 | 12.2 | General statistical considerations | 12.2 General statistical considerations Statistical methods will be detailed in the Sponsor statistical analysis plan. Continuous variables will be presented as number of non-missing values, mean, standard deviation, median, minimum, maximum and quartiles. For categorical variables, descriptive statistics will include ... | [] |
NCT02667457 | 12.3 | Demographics and Other Participant Characteristics | 12.3 Demographics and Other Participant Characteristics Demographic and other baseline data will be summarized descriptively. All background and demographic data will be listed in detail. | [] |
NCT02667457 | 12.4 | Efficacy | 12.4 Efficacy
Primary endpoint of PoC: The feasibility of imaging apoptotic activity in carotid atherosclerotic plaques using 99mTc-rhAnnexin V-128 will be determined by the data monitoring committee (visual image review and consensus).
Primary endpoint of Phase II: Efficacy of 99mTc-rhAnnexin V-128 planar and SPECT/... | [
"Primary endpoint of PoC:",
"Primary endpoint of Phase II:",
"Secondary endpoints:"
] |
NCT02667457 | 12.5 | Safety | 12.5 Safety The statistical analysis of safety data will be mainly descriptive in nature. | [] |
NCT02667457 | 12.5.1 | Adverse Events / Serious Adverse Events | 12.5.1 Adverse Events / Serious Adverse Events All original AE/SAE terms will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). System organ classes and preferred terms will be used in the analyses. The type and incidence of AEs/SAEs, as well as severity and relatedness to the investigational pr... | [] |
NCT02667457 | 12.5.2 | Laboratory Tests | 12.5.2 Laboratory Tests Descriptive statistics including shift tables will be generated for all laboratory tests performed i.e. the actual values and the changes from pre-injection by cross tabulations (with classes for below, within, and above normal range). Laboratory data will be analysed with respect to the normal ... | [
"1 3. A d v er s e E v e nt s a n d ot h er S af et y A s p e ct s",
"1 3. 1 D efi niti o n of A d v er s e E v e nt s",
"1 3. 2 D efi niti o n of S eri o u s A d v er s e E v e nt s",
"1 3. 3 Pr o c e d ur e i n C a s e of Pr e g n a n c y",
"1 3. 4 N e w S af et y I nf or m ati o n Aff e cti n g t h e C o... |
NCT02667457 | 15.2.2 | Authorities | 15.2.2 Authorities The protocol, name, and study centre of the Investigators, as well as other required documents will be submitted to Health Canada ( Regulatory Authority), the Ottawa Hospital Science Network Research Ethics Board and the Ottawa Heart Institute Research Corporation according to requirements for review... | [] |
NCT02667457 | 15.3 | Arrangement for Use of Information and Publication of Clinical Study Data | 15.3 Arrangement for Use of Information and Publication of Clinical Study Data All information regarding the investigational product under study in the outlined protocol and the manufacturer's operations, such as, but not limited to, patent applications, formulas, manufacturing processes, scientific data, or formulatio... | [] |
NCT02667457 | 15.4 | Records Related to the Clinical Study and Confidentiality | 15.4 Records Related to the Clinical Study and Confidentiality The Investigator must retain e-CRFs and source documents of all enrolled participants (i.e. all participants who gave consent to be screened for the study), investigational product disposition, and other documents required by regulation, in his/her possessi... | [] |
NCT02667457 | 15.5 | Protocol Amendment and/or Revision and Protocol Deviations | 15.5 Protocol Amendment and/or Revision and Protocol Deviations Any deviation from the protocol that has not been approved by the Sponsor or designee and by the REB/regulatory authorities may result in the discontinuation from the trial of the site involved. However, in the event of any medical emergency, the Investiga... | [] |
NCT02667457 | 15.6 | Qualification of the Investigators and delegation of responsibility | 15.6 Qualification of the Investigators and delegation of responsibility The Investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the study. He/she should meet all qualifications specified by the applicable regulatory requirements and should provi... | [] |
NCT02667457 | 15.7 | Conflict of Interest and Financial Disclosure | 15.7 Conflict of Interest and Financial Disclosure There are no conflicts of interest to declare related to this study. The Principal Investigator is receiving financial support and the investigational product from the manufacturer to cover the cost of conducting this study. Disclosable financial interests will be reco... | [] |
NCT02667457 | 15.8 | Investigator and Manufacturer Indemnity | 15.8 Investigator and Manufacturer Indemnity The investigator and the Sponsor will provide appropriate medical treatment and care in the event of a study related injury or illness. The sponsor has covered this study by means of insurance for the participant according to national requirements. The name and the address o... | [] |
NCT02667457 | 16 | References | 16. References - 1. Murray CJ and Lopez AD. Alternative projections of mortality and disability by cause 1990- 2020: Global Burden of Disease Study. Lancet. 1997;349:1498-504. - 2. Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nel... | [
"Radiolabeling procedure"
] |
NCT02667457 | C | a uti o n ar y N ot e s: | C a uti o n ar y N ot e s: - T c- 9 9 m p ert e c h n et at e el u at e s h o ul d b e o bt ai n e d fr o m a g e n er at or w hi c h h a s b e e n el ut e d wit hi n t h e l a st 2 4 h o ur s. - T c- 9 9 m p ert e c h n et at e el u at e w hi c h i s m or e t h a n 6- h o ur ol d fr o m t h e ti m e of el uti o n s h ... | [
"Stability and Shelf Life of the Kit for radiopharmaceutical preparation of 99mTc-rhAnnexin V-128",
"Stability of the Finished Product (99mTc-rhAnnexin V-128 radiolabelled Imaging Agent)",
"Serious Adverse Event (SAE) Reporting Form",
"TO BE COMPLETED BY AAA GLOBAL PV (INTERNAL USE ONLY)",
"PREGNANCY REPORT... |
NCT02682381 | A | 24-Week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Aged 1 Year Through 17 Years With Short Bowel Syndrome who are Dependent on Parenteral Support | A 24-Week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Aged 1 Year Through 17 Years With Short Bowel Syndrome who are Dependent on Parenteral Support | Clinical Study Protocol TED-C14-006 | |-------------------------------------| | Version 1.0 | ... | [
"SYNOPSIS",
"Protocol TED-C14-006",
"Inclusion Criteria",
"Exclusion Criteria",
"Test Product, Dose, and Mode of Administration:",
"Reference Therapy, Dose and Mode of Administration:",
"Criteria for Evaluation:",
"Safety and tolerability:",
"Pharmacodynamics:",
"Statistical methods:",
"Demograp... |
NCT02682381 | I | agree: | I agree: To assume responsibility for the proper conduct of this clinical study at this site and to conduct the study in compliance with this protocol, any future amendments, and with any other study conduct procedures provided by the sponsor, That I am aware of, and will comply with, the internationally recognized cod... | [
"LIST OF ABBREVIATIONS AND DEFINITION OF TERMS",
"1 INTRODUCTION",
"1.1 Background",
"Compound",
"Preclinical Studies",
"Clinical Studies",
"1.2 Rationale for the Clinical Study",
"1.3 Rationale for Study Design",
"Dose",
"Treatment Duration/Design",
"Subject Population",
"Gastrointestinal Scr... |
NCT02690714 | 1 | Introduction | 1 Introduction | [] |
NCT02690714 | 1.1 | Background | 1.1 Background | [] |
NCT02690714 | 1.1.1 | Overview of Hypoplasminogenemia | 1.1.1 Overview of Hypoplasminogenemia Hypoplasminogenemia is a rare autosomal recessive genetic disorder that leads to a variety of significant clinical manifestations primarily associated with fibrous depositions on mucous membranes throughout the body (Schott et al., 1998). Plasminogen is a naturally occurring protei... | [] |
NCT02690714 | 1.1.2 | Current Treatment for Hypoplasminogenemia | 1.1.2 Current Treatment for Hypoplasminogenemia There are 2 forms of plasminogen: Glu and Lys. Most literature references of plasminogen replacement therapy are based on the Lys form; it is important to note the Prometic plasminogen Version 5 Page 20 of 75 is the Glu form, which has a longer half-life (approximately 2.... | [] |
NCT02690714 | 1.2 | Pre-clinical Experience with Plasminogen | 1.2 Pre-clinical Experience with Plasminogen A literature review revealed the following information regarding work done in plasminogen deficient animal models. Bugge et al. (1995) generated the first plasminogen-deficient homozygous (PLG -/- ) knockout mouse model to study the physiological role of plasminogen in devel... | [] |
NCT02690714 | 1.3 | Clinical Experience with Plasminogen | 1.3 Clinical Experience with Plasminogen Prometic Biotherapeutics, Inc. (hereafter referred to as the sponsor), is developing Plasminogen (Human) Intravenous Lyophilized Solution (the investigational medicinal product [IMP]), for the treatment of hypoplasminogenemia. The IMP is derived from pooled plasma donated by US ... | [] |
NCT02690714 | 1.4 | Benefit Versus Risk and Study Rationale | 1.4 Benefit Versus Risk and Study Rationale The prognosis of hypoplasminogenemia is variable depending on the extent, location(s), length, and site of the lesions. A number of patients have died or have suffered loss of affected organ functions, such as sight and dentition, as a result of hypoplasminogenemia (Mehta and... | [] |
NCT02690714 | 1.5 | Dose Rationale | 1.5 Dose Rationale A successful outcome for this study is defined as achieving a trough level of plasminogen that is at least 10% above the subject's baseline level for at least 3 measurements during the 12 weeks of treatment in Segment 2. Table 1 shows the results of a single IV infusion of Plasminogen 6 mg/kg, in the... | [
"Protocol Number: 2002C011G"
] |
NCT02690714 | 2 | Study Objectives | 2 Study Objectives | [] |
NCT02690714 | 2.1 | Primary Objectives | 2.1 Primary Objectives The primary objectives of the study are: - To achieve an increase of individual trough plasminogen activity by at least an absolute 10% (i.e., 10 U/dL) from baseline in adult and pediatric subjects with hypoplasminogenemia during the 12 weeks of plasminogen replacement therapy in Segment 2; and -... | [] |
NCT02690714 | 2.2 | Secondary Objectives | 2.2 Secondary Objectives The secondary objectives of the study are: - To evaluate the safety and tolerability of plasminogen replacement therapy during the 48 weeks of dosing; and - To evaluate the efficacy of plasminogen replacement therapy on clinically evident or visible symptoms of hypoplasminogenemia during the 12... | [] |
NCT02690714 | 3 | Study Design | 3 Study Design | [] |
NCT02690714 | 3.1 | Overall Study Design | 3.1 Overall Study Design Approximately 15 subjects aged 2 to 80 years with hypoplasminogenemia will be enrolled to ensure a sample size of at least 10 PK-evaluable subjects. At least 2 pediatric subjects, aged 2 to 18 years, will be enrolled. An evaluable subject for PK is defined as a subject who completes Segment 2 o... | [
"Screening",
"Segment 1",
"Segment 2",
"Segment 3"
] |
NCT02690714 | 3.2 | Treatment, Dosage, and Duration | 3.2 Treatment, Dosage, and Duration In Segment 1, a single dose of 6.6 mg/kg Plasminogen will be administered to each subject. However, subjects who have documented individual PK profiles with the sponsor (e.g., due to participation in the previous Phase 1 study and received 6 mg/kg Plasminogen) do not need to undergo ... | [] |
NCT02690714 | 3.3 | Subject Population | 3.3 Subject Population A total of 15 subjects with hypoplasminogenemia will be enrolled in the study to ensure at least 10 evaluable subjects. At least 2 pediatric subjects (aged 2 to 18 years) will be enrolled. | [] |
NCT02690714 | 3.3.1 | Inclusion Criteria | 3.3.1 Inclusion Criteria Subjects must meet all the criteria below to participate in this study: - 1. Subject or legal guardian has provided informed consent (as well as assent by subjects with ages dictated by local Investigational Review Board [IRB] guidelines). - 2. Subject is male or female between the ages of 2 an... | [] |
NCT02690714 | 3.3.2 | Exclusion Criteria | 3.3.2 Exclusion Criteria Subjects must meet none of the criteria below: - 1. Subject has a history of anaphylactic reactions to blood or blood products that may interfere with participation in the study in the opinion of the investigator. - 2. Subject has uncontrolled hypertension. - 3. Subject has clinical or laborato... | [] |
NCT02690714 | 3.4 | Measures to Minimize or Avoid Bias | 3.4 Measures to Minimize or Avoid Bias | [] |
NCT02690714 | 3.4.1 | Randomization | 3.4.1 Randomization Subjects will not be randomized. | [] |
NCT02690714 | 3.4.2 | Blinding | 3.4.2 Blinding This study will not be blinded. | [] |
NCT02690714 | 3.5 | Study Procedures | 3.5 Study Procedures The schedule of events is provided in Table 2. Version 5 Page 33 of 75 Confidential Protocol Number: 2002C011G IND Number: 16186 Table 2. Schedule of Events by Visit | | | | Segment 1a | | | Segment 2l | Segment 3l | End ofStudyVisit | SafetyFollow-up | | | | | |------------------------------------... | [] |
NCT02690714 | 3.5.1 | Procedures by Visit | 3.5.1 Procedures by Visit
Screening - Informed consent/assent - Eligibility review - Demographics - Medical history - Disease history and past and current treatment - Medications taken in the past year - Weight - Vital signs (temperature, respiratory rate, BP, and heart rate) - Physical examination - Blood sample for ... | [
"Screening",
"Baseline Assessments (Either Segment 1, Day -4 or Segment 2, Day 0)",
"Segment 1, Week 0, Day -4 (Participants Only)",
"Segment 1, Week 0, Day -3, Day -2, and Day -1 (Participants Only)",
"Segment 2, Week 1, Day 0",
"Segment 2, Week 2, Week 6, Week 10",
"Segment 2, Weeks 4 and 8",
"Segme... |
NCT02690714 | 3.5.2 | Description of Assessments | 3.5.2 Description of Assessments
Informed Consent/Assent Informed consent is a process that includes the signing of the Informed Consent Form (ICF) for all subjects. Assent will be required from subjects younger than 18 years with consent from their legally authorized representative according to state law. Patients sh... | [
"Informed Consent/Assent",
"Demographics",
"Medical History and Disease History and Symptoms",
"Prior Medications and Treatments",
"Plasminogen Genetic Test",
"PK Analyses for Plasminogen Activity and Antigen Levels",
"Segment 1",
"Segment 2",
"Segment 3",
"PK Sample Handling:",
"Clinical Labora... |
NCT02690714 | 3.6 | Stopping Rules and Withdrawal | 3.6 Stopping Rules and Withdrawal | [] |
NCT02690714 | 3.6.1 | Study Termination | 3.6.1 Study Termination The sponsor and/or a principal investigator may elect to terminate the study early as defined by the clinical trial agreement. Any decision to voluntarily suspend or terminate a clinical trial will be carefully reviewed and fully justified. The sponsor will notify the FDA and the IRB of any susp... | [] |
NCT02690714 | 3.6.2 | Stopping Rules | 3.6.2 Stopping Rules Any subject who experiences any of the following occurrences will suspend the IMP treatment until further assessments: - Anaphylactic response to study drug administration - A significant AE that, in the investigator's opinion, necessitates suspension oftreatment - Confirmed presence of neutralizin... | [] |
NCT02690714 | 3.6.3 | Withdrawal and Replacement of Subjects | 3.6.3 Withdrawal and Replacement of Subjects Subjects will be withdrawn for the following reasons: - The subject withdraws consent (no justification is required); and/or - The subject develops a condition that in the investigator's opinion makes it medically necessary that the subject not continue in the study. After a... | [] |
NCT02690714 | 3.7 | Safety Monitoring Committee | 3.7 Safety Monitoring Committee The SMC is composed of the sponsor's Medical Monitor and an independent Medical Monitor and will review the safety data (e.g., AE listings, laboratory data, vital sign data, trough levels) biweekly during Segments 1 and 2, as data become available. Formal meetings of the SMC will be conv... | [] |
NCT02690714 | 3.8 | Subject Identification | 3.8 Subject Identification Subjects will be identified by their initials and a numerical code in the database. All subjects who sign the ICF/assent will receive a Subject Identification Number according to the following format: XX-YYY (site number-subject number) to be defined in a Study Manual. The anonymity of subjec... | [] |
NCT02690714 | 3.9 | Treatment Compliance | 3.9 Treatment Compliance The IMP will be provided by the sponsor and delivered to participating sites. IMP administration will be performed and recorded by study personnel or home nurse, or by subjects or their caregivers trained in self-administration. Version 5 Page 48 of 75 Confidential Subjects will be given instru... | [] |
NCT02690714 | 3.10 | Protocol Deviations | 3.10 Protocol Deviations Every effort should be made to avoid deviations from the protocol during the conduct of the trial. When protocol deviations do occur, the Investigator should promptly inform the Monitor, and the implications of each deviation must be reviewed and discussed. Any deviation must be documented, sta... | [] |
NCT02690714 | 4 | Restrictions | 4 Restrictions | [] |
NCT02690714 | 4.1 | Concomitant and Prohibited Medications | 4.1 Concomitant and Prohibited Medications The administration of concomitant medications, in accordance with the standard of care for subjects with hypoplasminogenemia, is permitted during the study. Any medications (e.g., prescription and non-prescription medications, blood products, herbal/natural products) taken by ... | [] |
NCT02690714 | 4.2 | Other Restrictions | 4.2 Other Restrictions None. | [] |
NCT02690714 | 5 | Reporting of Adverse Events | 5 Reporting of Adverse Events Adverse events will be recorded from the first dose of IMP administration through 30 days after administration of IMP and collected by observation and reporting. AEs will be elicited from subjects by asking questions regarding changes in the subject's status at each visit. Version 5 Page 4... | [] |
NCT02690714 | 5.1 | Definitions | 5.1 Definitions | [] |
NCT02690714 | 5.1.1 | Adverse Event | 5.1.1 Adverse Event An AE is any untoward medical occurrence (whether or not considered to have a causal relationship to IMP) in a study subject administered an IMP. Therefore, an AE can be any unfavorable and unintended sign (including clinically significant laboratory finding), symptom, or disease temporally associat... | [] |
NCT02690714 | 5.1.2 | Adverse Drug Reaction | 5.1.2 Adverse Drug Reaction All noxious and unintended responses to an IMP related to any dose should be considered ADRs. The phrase "responses to an IMP" means that a causal relationship between the IMP and the AE is at least a reasonable possibility, that is, the relationship cannot be ruled out. | [] |
NCT02690714 | 5.1.3 | Serious Adverse Event | 5.1.3 Serious Adverse Event An SAE is any untoward medical occurrence that at any dose: - Results in death. - Is life-threatening (i.e., the subject was at immediate risk of death from the AE as it occurred. This does not include an event that, had it occurred in a more severe form or was allowed to continue, might hav... | [] |
NCT02690714 | 5.1.4 | Assessment of Severity | 5.1.4 Assessment of Severity The severity of all AEs and SAEs must be assessed according to the following categories: - Mild The AE/SAE is easily tolerated by the subject, causes minimal discomfort and does not interfere with everyday activities; or - Moderate The AE/SAE is sufficiently discomforting to interfere with ... | [] |
NCT02690714 | 5.1.5 | Assessment of Causality | 5.1.5 Assessment of Causality The following 4-point scale will be used by the investigator to rate the relationship of the adverse event to the IMP: - Definitely related: A clinical event (including laboratory test abnormality) occurring in a plausible time relationship to IMP administration and which cannot be explain... | [] |
NCT02690714 | 5.2 | Eliciting and Reporting Adverse Events | 5.2 Eliciting and Reporting Adverse Events The condition of the patient will be monitored throughout the study. At each visit, AEs will be elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs will also be elicited through the use of Subj... | [] |
NCT02690714 | 5.3 | Serious Adverse Event Reporting | 5.3 Serious Adverse Event Reporting All AEs must be evaluated as potential serious adverse events (SAEs). All AEs assessed as serious must be reported beginning from the time of first dose of IMP until 30 days post dose. SAEs must be followed until the event resolves, the event or sequelae stabilize, or it is unlikely ... | [] |
NCT02690714 | 5.3.1 | SAE Reporting to the CRO | 5.3.1 SAE Reporting to the CRO All SAEs will be reported within 24 hours of the investigator becoming aware of the event to the Pharmacovigilance (PV) CRO Safety Department submitting the Safety Report 24/7 on the fax number below. Toll Free Fax US: 1-866-246-1693 Version 5 Page 52 of 75
Toll Free Fax Norway: 800-24-7... | [
"Toll Free Fax Norway: 800-24-747."
] |
NCT02690714 | 5.3.2 | Institutional Review Board/Ethics Committee | 5.3.2 Institutional Review Board/Ethics Committee All AEs will be reported to the IRB/EC according to the guidelines of the IRB/EC. However, as a general guideline, IRBs/EC need to know about any AEs that are unexpected or of a greater severity than what is reported in the IB. Reporting is always required for all SAEs.... | [] |
NCT02690714 | 5.3.3 | Expedited SUSAR Reporting (Sponsor Responsibility) | 5.3.3 Expedited SUSAR Reporting (Sponsor Responsibility) The sponsor will submit a written IND Safety Report (i.e., completed FDA Form 3500A and/or CIOMS form) within 15 calendar days of receipt to the responsible review division of the FDA and the Norwegian Medicines Agency, as required, for any observed or volunteere... | [] |
NCT02690714 | 5.4 | Pregnancy | 5.4 Pregnancy Every effort must be made to avoid a pregnancy during the trial. Contraception should be used in accordance with Inclusion Criterion #6, and the techniques discussed at Screening should preferably not be changed during the course of the trial. A pregnancy test will be performed at Screening and at each st... | [] |
NCT02690714 | 5.5 | Procedure for Breaking the Blind | 5.5 Procedure for Breaking the Blind This is not a blinded study. | [] |
NCT02690714 | 5.6 | Follow-up of Adverse Events | 5.6 Follow-up of Adverse Events The responsible investigator will follow up each AE until it is resolved or until the medical condition of the patient has returned to baseline, and all relevant follow-up information has been reported to the sponsor. | [] |
NCT02690714 | 6 | Statistical Analysis | 6 Statistical Analysis | [] |
NCT02690714 | 6.1 | Datasets for Analysis | 6.1 Datasets for Analysis Safety population: Includes any subject who receives at least one dose of the IMP and provides safety data for at least one non-screening visit. PK population: Includes subjects who have completed Segment 2 dosing and have provided sufficient samples for PK assessments. Version 5 Page 54 of 75... | [] |
NCT02690714 | 6.2 | Handling of Missing Data | 6.2 Handling of Missing Data No missing data will be imputed. Missing plasminogen activity or antigen data will be ignored in the calculation of PK parameters. | [] |
NCT02690714 | 6.3 | Analyses Plan | 6.3 Analyses Plan Details will be provided in a Statistical Analysis Plan (SAP), which will be finalized before the database lock. | [] |
NCT02690714 | 6.3.1 | Demographics and Baseline Characteristics | 6.3.1 Demographics and Baseline Characteristics Subjects' demographic and baseline clinical characteristics will be summarized descriptively. Continuous variables will be presented as mean, standard deviation, median, and range. Categorical parameters will be presented as numbers and percentages. | [] |
NCT02690714 | 6.3.2 | Pharmacokinetic/Pharmacodynamic Analysis | 6.3.2 Pharmacokinetic/Pharmacodynamic Analysis The primary endpoint is the number and percentage of subjects who achieve the target plasminogen activity trough levels for at least 3 measurements in 12 weeks during Segment 2. Primary endpoint success is defined as at least 80% of evaluable subjects (i.e., 8 or more) ach... | [] |
NCT02690714 | 6.3.3 | Efficacy Analysis | 6.3.3 Efficacy Analysis The primary endpoint is: Overall Clinical Success in number and size of lesions or change in organ functionality at 48 weeks The secondary efficacy endpoints are: - Overall Clinical Success in number and size of lesions or change in organ functionality at 12 weeks - CGI scores at 12 and 48 weeks... | [] |
NCT02690714 | 6.3.4 | Safety Analysis | 6.3.4 Safety Analysis For safety analyses, treatment emergent adverse events (TEAEs) and SAEs will be summarized descriptively. Clinical laboratory tests (hematology, biochemistry, urinalysis, fibrinolysis/coagulation) will be presented in summary and shift tables. The numbers of subjects who had changes from baseline ... | [] |
NCT02690714 | 6.4 | Sample Size | 6.4 Sample Size Approximately 15 subjects with hypoplasminogenemia will be enrolled in this study to achieve at least 10 evaluable subjects. No formal calculation was made for sample size because of the rarity of the disease. The sample size is based on known patients who have hypoplasminogenemia. | [] |
NCT02690714 | 6.5 | Interim Analysis | 6.5 Interim Analysis The data in this study will be conducted in stages. An initial analysis of the PK data will be conducted when at least 10 subjects have completed Segment 2 dosing and have provided sufficient samples for PK assessments. The second data analysis will be conducted when all subjects have either comple... | [] |
NCT02690714 | 7 | Management of Investigational Medicinal Product | 7 Management of Investigational Medicinal Product | [] |
NCT02690714 | 7.1 | Packaging and Labeling in the US | 7.1 Packaging and Labeling in the US The IMP for IV administration is in a lyophilized presentation and will be available in 50 mL vial size. Each vial contains 62.5 mg Plasminogen, which will yield a concentration of 5 mg/mL after it is reconstituted in 12.5 mL of Water for Injection. The IMP is labeled as below: Prot... | [] |
NCT02690714 | 7.2 | Storage | 7.2 Storage The plasminogen IMP must be stored lyophilized at ≤ 2 °C to 8 °C in a secured area until used. The temperature in the storage area should be monitored with properly calibrated instruments and monitored on a temperature log. Subjects receiving and storing IMP at home can store their IMP in a non-monitored re... | [] |
NCT02690714 | 7.3 | Accountability | 7.3 Accountability The principal investigator is responsible for ensuring that accurate inventory records of IMP are properly maintained. The principal investigator or designee will inventory all shipments upon receipt, acknowledge possession by signing all required documentation, and return the required documentation ... | [] |
NCT02690714 | 7.4 | Shipment, Returns, and Destruction | 7.4 Shipment, Returns, and Destruction IMP will be shipped from Prometic Biotherapeutics to a selected Central Drug Repository (one in the US and one in Norway). The Central Drug Repositories will ship IMP to the sites and/or directly to subjects' homes or treating study nurse office location. Details regarding the dru... | [] |
NCT02690714 | 7.5 | Preparation | 7.5 Preparation IMP infusions should be prepared by a pharmacist or a qualified designee (subjects will be trained by site personnel for home preparation and infusion). IMP must be removed from refrigerated storage and brought to room temperature for reconstitution with 12.5 mL of Water for Injection using sterile tech... | [] |
NCT02690714 | 7.6 | Administration | 7.6 Administration Only eligible and enrolled subjects will receive IMP. The entire dose of the Plasminogen IV solution should be calculated on the basis of each subject's body weight and infused over a period of 10 to 30 minutes. IMP will be administered using a syringe with filter or disk filter according to the inst... | [] |
NCT02690714 | 8 | Records Management | 8 Records Management | [] |
NCT02690714 | 8.1 | Direct Access to Source Data/Documents | 8.1 Direct Access to Source Data/Documents The investigator will permit study-related monitoring, audits, IRB review, and regulatory inspection(s), providing direct access to source data and documents. The investigator or designee must record study participation details including enrollment, safety, and efficacy inform... | [] |
NCT02690714 | 8.2 | Data Collection and Management | 8.2 Data Collection and Management Data generated as per protocol will be entered onto the eCRF in accordance with the ICH Topic E6 (R1) Guidelines for GCP (CPMP/ICH/135/95). When the eCRFs have been completed, a monitor, with the assistance of the study site coordinator, will verify the source documentation records an... | [] |
NCT02690714 | 8.3 | Record Keeping | 8.3 Record Keeping The investigator is responsible for maintaining all records pertaining to the clinical trial and for ensuring complete and accurate documentation. The investigator is responsible for maintaining a subject identification log. This confidential subject identification log provides the link between named... | [] |
NCT02690714 | 9 | Quality Control and Quality Assurance | 9 Quality Control and Quality Assurance | [] |
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