protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04922554 | 12.4 | Demographics, Baseline Characteristics, and Subject Disposition | 12.4 Demographics, Baseline Characteristics, and Subject Disposition Demographics (including age, gender, ethnicity, and race) and baseline characteristics will be summarized in the ITT Analysis Set by treatment group. Descriptive statistics of the duration of test article treatment will be provided by treatment group ... | [] |
NCT04922554 | 12.5 | Efficacy Endpoint(s) | 12.5 Efficacy Endpoint(s) The study is exploratory with respect to efficacy determination. Efficacy will be evaluated based on endpoints defined by subject-reported NTM symptoms, subject-reported outcomes and quality of life measures, and microbiologic assessment. Additional endpoints to assess efficacy will be defined... | [] |
NCT04922554 | 12.5.1 | Primary Efficacy Endpoints | 12.5.1 Primary Efficacy Endpoints The primary determination of efficacy is based on subject assessment of symptoms. Several definitions of clinical response will be defined, including but not limited to those listed in Section 4; all definitions will be provided in the SAP. For each definition, the number and percentag... | [] |
NCT04922554 | 12.5.2 | Secondary Efficacy Endpoints | 12.5.2 Secondary Efficacy Endpoints | [] |
NCT04922554 | 12.5.2.1 | Patient-Reported Outcomes and Quality of Life | 12.5.2.1 Patient-Reported Outcomes and Quality of Life For each patient-reported outcome and quality of life endpoint, analyses will be conducted in the ITT Analysis Set. Available data will be used; there will be no substitutions for missing data. The QOL-B includes domains for physical functioning, role functioning, ... | [] |
NCT04922554 | 12.5.2.2 | Microbiological Response | 12.5.2.2 Microbiological Response The number and percentage of subjects with a decrease in the mycobacterial load will be determined by treatment group at Day 84 in the ITT Analysis Set. Exact 2-sided 95% CIs for the point estimate of the percentage of subjects of subjects with a decrease in mycobacterial load in each ... | [] |
NCT04922554 | 12.6 | Safety Endpoint(s) | 12.6 Safety Endpoint(s) All safety data will be analyzed in the Safety Analysis Set. Adverse events will be coded using the Medical Dictionary of Regulatory Activities. The incidence of treatment-emergent adverse events will be presented by system organ class (SOC) and preferred term (PT), by SOC, PT and relationship t... | [] |
NCT04922554 | 12.7 | Data Monitoring Committee | 12.7 Data Monitoring Committee Given the exploratory nature of this Phase 2 study using a product with a well-established safety profile, a data monitoring committee will not be utilized for this study. | [] |
NCT04922554 | 13 | ADMINISTRATIVE CONSIDERATIONS | 13 ADMINISTRATIVE CONSIDERATIONS | [] |
NCT04922554 | 13.1 | Investigators and Study Administrative Structure | 13.1 Investigators and Study Administrative Structure The investigator will permit study-related monitoring, audits, IRB/IEC/REB review, and regulatory inspections by providing direct access to source data and documents. All information will be recorded on source documents. All required data will be recorded in the eCR... | [] |
NCT04922554 | 13.2 | Institutional Review Board or Independent Ethics Committee Approval | 13.2 Institutional Review Board or Independent Ethics Committee Approval The protocol and the proposed ICF must be reviewed and approved by a properly constituted IRB/IEC/REB before study start. A signed and dated statement that the protocol and ICF have been approved by the IRB/IEC/REB must be given to the sponsor bef... | [] |
NCT04922554 | 13.3 | Ethical Conduct of the Study | 13.3 Ethical Conduct of the Study This clinical study was designed and shall be implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US 21 Code of Federal Regulations, and Japane... | [] |
NCT04922554 | 13.4 | Patient Information and Consent | 13.4 Patient Information and Consent The investigator will provide for the protection of the subjects by following all applicable regulations. These regulations are available upon request from the sponsor. The ICF must be reviewed by the sponsor and approved by the IRB/IEC/REB. Before any procedures specified in the pr... | [] |
NCT04922554 | 13.5 | Direct Access, Data Handling, and Record Keeping | 13.5 Direct Access, Data Handling, and Record Keeping | [] |
NCT04922554 | 13.5.1 | Investigator | 13.5.1 Investigator The investigator will permit study-related monitoring, audits, IRB/IEC/REB review, and regulatory inspections by providing direct access to source data and documents. All information will be recorded on source documents. All required data will be recorded in the eCRFs. | [] |
NCT04922554 | 13.5.2 | Sponsor | 13.5.2 Sponsor The data are entered into an electronic database via eCRFs. The sponsor medical monitor reviews the data for safety information. The data are reviewed for completeness and logical consistency. Automated validation checks identify missing data, out-of-range data, and other data inconsistencies. The centra... | [] |
NCT04922554 | 13.6 | Protocol Adherence | 13.6 Protocol Adherence | [] |
NCT04922554 | 13.6.1 | Violations/Deviations | 13.6.1 Violations/Deviations Investigators will agree to apply due diligence to avoid protocol deviations. Under no circumstances should the investigator contact the sponsor or its agents to request approval of a prospective protocol deviation, as no authorized deviations are permitted. If the investigator feels a prot... | [] |
NCT04922554 | 13.6.2 | Protocol Amendments | 13.6.2 Protocol Amendments Any change or addition to the protocol can only be made in a written protocol amendment that must be approved by the sponsor, Health Authorities where required, and the IRB/IEC/REB. Only amendments that are required for subject safety may be implemented prior to IRB/IEC/REB approval. Notwiths... | [] |
NCT04922554 | 13.7 | Subject Injury | 13.7 Subject Injury In general, subject to specific provisions in the clinical study agreement (CSA), if a subject is injured as a direct result of a test article, the sponsor will pay for reasonable and necessary medical treatment for the injury, to the extent that such expenses are not covered by the subject's medica... | [] |
NCT04922554 | 13.8 | Pre-study Documentation | 13.8 Pre-study Documentation The investigator must provide the sponsor with the following documents before enrolling any subjects: - Completed and signed Form FDA 1572 or equivalent. - All applicable country-specific regulatory forms. - Current signed and dated curricula vitae and medical license (as applicable) for th... | [] |
NCT04922554 | 13.9 | Retention of Data | 13.9 Retention of Data The investigator shall retain and preserve 1 copy of all data generated in the course of the study, specifically including but not limited to those defined by GCP as essential, for the longer of: (a) 2 years after the last marketing authorization for the investigational test article has been appr... | [] |
NCT04922554 | 13.10 | Publication and Disclosure Policy | 13.10 Publication and Disclosure Policy The sponsor assures that the key design elements of this protocol will be posted in a publicly accessible database such as clinicaltrials.gov. In addition, upon study completion and finalization of the study report, the results of this study will be submitted for publication and/... | [] |
NCT04922554 | 14 | REFERENCE LIST | 14 REFERENCE LIST Daley CL, Iaccarino JM, Lange C, et al. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline: Executive Summary. Clinical Infectious Diseases. 2020;71(4):e1-e36. Frizzell M, Carr E, Brust K. Omadacycline for treatment of Mycobacterium... | [
"Schedule of Assessments",
"Equations and Conversion Factors",
"Sputum Induction Guidelines",
"Introduction",
"Recommended Equipment",
"CONTRAINDICATIONS TO SPUTUM INDUCTION",
"Instructions:",
"Preparation",
"Nebulization",
"NTM Symptom Questionnaires",
"NTM Symptom Assessment Questionnaire – Ba... |
NCT04922554 | N | T M S y m pt o m Ass ess m e nt Q u esti o n n air e – All Ot h er Visits | N T M S y m pt o m Ass ess m e nt Q u esti o n n air e – All Ot h er Visits Pl e as e i n dic at e w hic h visit t h e q u esti o n n air e is b ei n g c o m pl et e d at: I nstr ucti o ns: Pl e as e i n dic at e if y o u h a v e ex p eri e nc e d a n y of t h e f oll o wi n g tw el v e s y m pt o ms wit hi n t h e p a... | [] |
NCT04964973 | 1 | Theory of pain specificity. | 1. Theory of pain specificity. It is one of the oldest and attempts to explain the transmission of pain. It is based on the concept that there is always a cause-effect relationship in the perception of pain (nociceptors, which project impulses onto specific pain nerve pathways). (A-delta (Aδ) and C-fibres) down the spi... | [] |
NCT04964973 | 2 | Pain pattern theory. | 2. Pain pattern theory. This theory emerged when it was shown that nociceptors responded to stimuli such as pressure and temperature, not just pain. It suggests that there are no specific nociceptors for pain, and that these result from a combination of stimulus intensity and the central summation pattern of impulses i... | [] |
NCT04964973 | 3 | Theory of gate control in pain perception. | 3. Theory of gate control in pain perception. This theory is based on the two previous theories and is widely used in the clinic, although it is not fully supported by experimental evidence. It was proposed by Melzack and Wall in 1965. According to these authors, pain passes through a series of nerve pathways, through ... | [] |
NCT04964973 | 4 | Endorphin and non-opioid theory of pain perception. | 4. Endorphin and non-opioid theory of pain perception. It involves the identification of narcotic-like substances secreted by the human body called endorphins. These substances act by locking onto narcotic receptors on nerve endings in the brain and spinal cord to block the transmission of the pain signal and thus prev... | [] |
NCT04964973 | 5 | Opioid multi-receptor theory for pain sensation. | 5. Opioid multi-receptor theory for pain sensation. It states that in the Central Nervous System, at the spinal and supraspinal level, narcotics relieve pain through various pathways, which may complement, compete or be specific to it. These areas are called mi, kappa and sigma. The mi receptor area produces supraspina... | [] |
NCT04964973 | 6 | Psychological theory of pain. | 6. Psychological theory of pain. Human behaviour is the main part of this theory. For this theory, pain is an abstract concept, which refers to a personal and private sensation of harm and, rather than a sensation, it is an unpleasant emotional experience, which is best defined as the awareness of a state of need. (2) ... | [
"Pain measurement methods",
"Verbal methods.",
"Behavioural assessments.",
"Physiological measures.",
"POSTOPERATIVE PAIN MANAGEMENT",
"Segmental responses.",
"Suprasegmental responses.",
"Cortical responses",
"CONTEXTUALISATION OF PAIN",
"PAIN AND PHYSIOTHERAPY",
"TRANSCUTANEOUS ELECTRICAL STIM... |
NCT04985682 | 1 | PROTOCOL SUMMARY | 1. PROTOCOL SUMMARY | [] |
NCT04985682 | 1.1 | Synopsis | 1.1 Synopsis | Title of the study:Phase 4,Multicenter, Prospective, Interventional, Post-Marketing Study in Hemophilia APatients in India Receiving ADVATE as On-demand or Prophylaxis Under Standard Clinical Practice | |-----------------------------------------------------------------------------------------------------... | [
"Objectives:",
"Primary:",
"Secondary:",
"Rationale:",
"Investigational product, dose, and mode of administration:",
"Methodology:",
"Inclusion and Exclusion Criteria:",
"Inclusion Criteria:",
"Exclusion Criteria:",
"Maximum duration of subject participation in the study:Approximately 7-8 months",... |
NCT04985682 | 1.2 | Schema | 1.2 Schema Figure 1. Study Design and Visit Schedule  | [] |
NCT04985682 | 1.3 | Schedule of Activities | 1.3 Schedule of Activities Table 1. Schedule of Study Procedures and Assessments | Procedures/Assessments | ScreeningVisit | BaselineVisit | Visit 1 | Visit 2 | UnscheduledVisit(s)a | End of TreatmentVisit | Study TerminationVisitb | |-------------------------------------------------------------------------------|-----... | [] |
NCT04985682 | 2 | INTRODUCTION | 2. INTRODUCTION | [] |
NCT04985682 | 2.1 | Indication and Current Treatment Options | 2.1 Indication and Current Treatment Options FVIII is the blood clotting factor deficient or absent in individuals with hemophilia A. Hemophilia A is an X-linked chromosomal recessive disorder that results from defective or deficient plasma FVIII and consequently insufficient coagulant activity. Approximately 1 in 5,00... | [] |
NCT04985682 | 2.2 | Product Background and Clinical Information | 2.2 Product Background and Clinical Information Baxalta US Inc., now part of Takeda, has developed a third-generation recombinant FVIII concentrate (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free Method [rAHF-PFM]) by the name of ADVATEii, produced by a genetically engineered Chinese hamster ovary (CHO) cell ... | [] |
NCT04985682 | 2.3 | Study Rationale | 2.3 Study Rationale The results derived from the ADVATE clinical development program have shown ADVATE to be well tolerated and efficacious for hemostatic control, including for perioperative management, in previously treated pediatric, adolescent and adult patients (PTPs) and in previously untreated pediatric patients... | [] |
NCT04985682 | 2.4 | Benefit/Risk Assessment | 2.4 Benefit/Risk Assessment At present, FVIII replacement is the only symptomatic therapy available for the treatment of hemophilia A. ADVATE has structural and functional characteristics similar to those of endogenous FVIII. The development of a production process that virtually eliminates the risk of pathogen transmi... | [] |
NCT04985682 | 2.5 | Compliance Statement | 2.5 Compliance Statement This study will be conducted in accordance with this protocol, the International Council for Harmonisation Guideline for Good Clinical Practice E6 (ICH GCP, 1996; E6 R2, 2017), Title 21 of the US Code of Federal Regulations (US CFR), the EU Directives (2001/20/EC; 2005/28/EC), and applicable na... | [] |
NCT04985682 | 3 | OBJECTIVES AND ENDPOINTS | 3. OBJECTIVES AND ENDPOINTS | [] |
NCT04985682 | 3.1 | Study Objectives | 3.1 Study Objectives | [] |
NCT04985682 | 3.1.1 | Primary Objective | 3.1.1 Primary Objective The primary objective of this study is to assess the safety of ADVATE based on serious adverse events (SAEs) (including FVIII inhibitors). | [] |
NCT04985682 | 3.1.2 | Secondary Objectives | 3.1.2 Secondary Objectives - To assess the safety of ADVATE based on adverse events (AEs) and changes in laboratory parameters - To assess the efficacy of prophylactic treatment with ADVATE - To assess the efficacy of on-demand treatment with ADVATE in the control of bleeding episodes | [] |
NCT04985682 | 3.2 | Study Endpoints | 3.2 Study Endpoints Table 3. Objectives and Endpoints | episodes | only | |---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04985682 | 4 | STUDY DESIGN | 4. STUDY DESIGN | [] |
NCT04985682 | 4.1 | Overall Design | 4.1 Overall Design This is a Phase 4, multicenter, prospective, interventional, post-marketing study in previously treated hemophilia A patients (PTPs) in India receiving ADVATE under standard clinical practice. All enrolled subjects who have met the inclusion and exclusion criteria will be treated with ADVATE accordin... | [] |
NCT04985682 | 4.2 | Scientific Rationale for Study Design | 4.2 Scientific Rationale for Study Design This phase 4 study is designed to evaluate the safety and efficacy of ADVATE when used under standard clinical practice (ie, per Product Label) in previously treated hemophilia A patients (PTPs) in India. | [] |
NCT04985682 | 4.3 | Justification for Dose | 4.3 Justification for Dose Subjects will be treated according to a regimen determined by the treating physician and in accordance with the national product label. Guidance on dosing for prophylactic and on-demand treatment can be found in the ADVATE Package Insert for India (see Appendix 4.1). For the ADVATE infusion t... | [] |
NCT04985682 | 4.4 | Duration of Subject Participation and Study Completion Definition | 4.4 Duration of Subject Participation and Study Completion Definition Any subject who provides informed consent (ie, signs and dates the informed consent form and assent form, if applicable) is considered enrolled in the study (see Section 8.1 and Appendix 1.5). The subject's maximum duration of participation is expect... | [] |
NCT04985682 | 4.5 | Sites and Regions | 4.5 Sites and Regions The study will be a multicenter study in India. For non-commercial use only | [] |
NCT04985682 | 5 | STUDY POPULATION | 5. STUDY POPULATION Each subject must participate in the informed consent process and provide written informed consent/assent before any procedures specified in the protocol are performed. | [] |
NCT04985682 | 5.1 | Inclusion Criteria | 5.1 Inclusion Criteria The subject will not be considered eligible for the study without meeting all of the criteria below. - 1. The subject or legally authorized representative (in case of study participants <18 years of age) gave written informed consent to participate in the study. - 2. Subject of any age with hemop... | [] |
NCT04985682 | 5.2 | Exclusion Criteria | 5.2 Exclusion Criteria The subject will be excluded from the study if any of the following exclusion criteria are met. - 1. Subject has known hypersensitivity to mouse or hamster proteins or to any of the excipients of FVIII concentrates. - 2. Subject has been diagnosed with bleeding disorder(s) other than congenital h... | [] |
NCT04985682 | 5.3 | Restrictions | 5.3 Restrictions No dietary or activity restrictions are associated with this study. | [] |
NCT04985682 | 5.4 | Reproductive Potential | 5.4 Reproductive Potential | [] |
NCT04985682 | 5.4.1 | Female Contraception | 5.4.1 Female Contraception Not applicable for this post-marketing study. | [] |
NCT04985682 | 5.4.2 | Male Contraception | 5.4.2 Male Contraception Not applicable for this post-marketing study. | [] |
NCT04985682 | 6 | STUDY INTERVENTION | 6. STUDY INTERVENTION | [] |
NCT04985682 | 6.1 | Investigational Product | 6.1 Investigational Product | [] |
NCT04985682 | 6.1.1 | Identity of Investigational Product | 6.1.1 Identity of Investigational Product ADVATE is formulated as a sterile, nonpyrogenic, lyophilized powder or friable solid of concentrated FVIII of white to off-white color and is provided in single-dose vials. Each vial of ADVATE is labeled with the antihemophilic factor (AHF) activity expressed in international u... | [] |
NCT04985682 | 6.1.2 | Blinding the Treatment Assignment | 6.1.2 Blinding the Treatment Assignment Not applicable. | [] |
NCT04985682 | 6.2 | Administration of Investigational Product | 6.2 Administration of Investigational Product ADVATE is to be administered intravenously after reconstitution. For reconstitution instructions, please refer to the ADVATE Package Insert for India (see Appendix 4.1). The prepared solution should be inspected for particulate matter and discoloration prior to administrati... | [] |
NCT04985682 | 6.2.1 | Allocation of Subjects to Treatment | 6.2.1 Allocation of Subjects to Treatment This is an open-label, uncontrolled, single-group, post-marketing study. Subjects will receive either prophylactic or on-demand treatment. The actual treatment given to individual subjects will be according to a regimen determined by the treating physician and in accordance wit... | [] |
NCT04985682 | 6.2.2 | Dosing | 6.2.2 Dosing The dosage and duration of treatment depend on the severity of FVIII deficiency, the location and extent of the bleeding, and the patient´s clinical condition. Dosing details are provided in the ADVATE Product Label for India. For non-commercial use only | [] |
NCT04985682 | 6.2.3 | Unblinding the Treatment Assignment | 6.2.3 Unblinding the Treatment Assignment Not applicable. | [] |
NCT04985682 | 6.2.4 | Dose Modification | 6.2.4 Dose Modification Not applicable. | [] |
NCT04985682 | 6.3 | Labeling, Packaging, Storage, and Handling of Investigational Product | 6.3 Labeling, Packaging, Storage, and Handling of Investigational Product | [] |
NCT04985682 | 6.3.1 | Labeling | 6.3.1 Labeling Each vial will be labeled with the actual potency in International Units and a Product Label. The Product Label will meet country-specific regulatory label requirements. | [] |
NCT04985682 | 6.3.2 | Storage | 6.3.2 Storage The investigator has overall responsibility for ensuring that investigational product is stored in a secure, limited-access location. Limited responsibility may be delegated to the pharmacy or member of the study team, but this delegation must be documented. Investigational products are distributed by the... | [] |
NCT04985682 | 6.4 | Drug Accountability | 6.4 Drug Accountability Investigators will be provided with sufficient amounts of the investigational product to carry out this protocol for the agreed number of subjects. The investigator or designee will acknowledge receipt of the investigational product, documenting shipment content and condition. Accurate records o... | [] |
NCT04985682 | 6.5 | Subject Compliance | 6.5 Subject Compliance Subjects must be instructed to bring unused investigational product and empty/used investigational product packaging to every visit. Drug accountability must be assessed at the container/packaging level for unused investigational product that is contained within the original tamper-evident sealed... | [] |
NCT04985682 | 6.6 | Prior and Concomitant Therapy | 6.6 Prior and Concomitant Therapy All non-study treatment received within 3 months prior to the screening visit and through the final study contact must be recorded in the subject's source document. The physician is expected to follow standard clinical practice and all kinds of medications and/or non-drug therapies are... | [] |
NCT04985682 | 6.6.1 | Prior Treatment | 6.6.1 Prior Treatment Prior treatment includes all treatment received within 6 months from the date of first dose of investigational product. Prior treatment information must be recorded in the subject's source document.In addition, the history of any hemophilia product usage for 6 months prior to screening must be rec... | [] |
NCT04985682 | 6.6.2 | Concomitant Treatment | 6.6.2 Concomitant Treatment All medications taken and non-drug therapies received within 3 months before providing informed consent until completion/termination will be recorded on the concomitant medications and nondrug therapies CRFs. For non-commercial use only | [] |
NCT04985682 | 6.6.3 | Permitted Treatment | 6.6.3 Permitted Treatment The physician is expected to follow standard clinical practice and all kinds of medications and/or non-drug therapies are allowed. The following medications and non-drug therapies are permitted before study entry and during the course of the study:
• Medications: - Hemostatic agents, such as ... | [
"• Medications:"
] |
NCT04985682 | 6.6.4 | Prohibited Treatment | 6.6.4 Prohibited Treatment - The use of a FVIII concentrate other than ADVATE (eg, any other plasma derived or recombinant FVIII product) will disqualify the subject from further participation in the study. For non-commercial use only - Immunomodulating drugs are also not allowed as concomitant medication (see also exc... | [] |
NCT04985682 | 7 | DISCONTINUATION OF STUDY INTERVENTION AND SUBJECT DISCONTINUATION/WITHDRAWAL | 7. DISCONTINUATION OF STUDY INTERVENTION AND SUBJECT DISCONTINUATION/WITHDRAWAL | [] |
NCT04985682 | 7.1 | Discontinuation of Study Treatment | 7.1 Discontinuation of Study Treatment Any subject may voluntarily withdraw (ie, reduce the degree of participation in the study) consent for continued participation and data collection. If investigational product is discontinued, regardless of the reason, the evaluations listed for the Study Termination Visit will be ... | [] |
NCT04985682 | 7.2 | Reasons for Discontinuation | 7.2 Reasons for Discontinuation The reason for discontinuation must be determined by the investigator and recorded in the subject's source document. If a subject is discontinued for more than 1 reason, each reason should be documented in the source and the most clinically relevant reason should be indicated. For non-co... | [] |
NCT04985682 | 7.3 | Withdrawal from the Study | 7.3 Withdrawal from the Study A subject may withdraw from the study at any time and for any reason without prejudice to his/her future medical care by the physician or at the institution, or may be withdrawn at any time at the discretion of the investigator or sponsor (eg, in the interest of subject safety). The invest... | [] |
NCT04985682 | 7.4 | Subjects "Lost to Follow-up" Prior to the Last Scheduled Visit | 7.4 Subjects "Lost to Follow-up" Prior to the Last Scheduled Visit A minimum of 3 documented attempts must be made to contact any subject who is lost to follow-up at any time point prior to the last scheduled contact (office visit or telephone contact). At least 1 of these documented attempts must include a written com... | [] |
NCT04985682 | 8 | STUDY ASSESSMENTS AND PROCEDURES | 8. STUDY ASSESSMENTS AND PROCEDURES | [] |
NCT04985682 | 8.1 | Informed Consent and Enrollment | 8.1 Informed Consent and Enrollment Investigators will choose patients for participation considering the study eligibility criteria. The investigator will exercise no selectivity so that no bias is introduced from this source. Prior to performing any trial assessments that are not part of routine medical care for the s... | [] |
NCT04985682 | 8.2 | Subject Identification Code | 8.2 Subject Identification Code The following series of numbers will comprise the SIC: protocol identifier (eg, TAK-761-4009) to be provided by the sponsor, 2- or 3-digit number study site number (eg, 02) to be provided by the sponsor, and 3-digit subject number (eg, 003) reflecting the order of providing informed cons... | [] |
NCT04985682 | 8.3 | Study Periods | 8.3 Study Periods The overall study periods are shown in Figure 1. Refer to Table 1 for the schedule of study activities and to Table 2 for an overview of the clinical laboratory assessments to be performed at each study visit, including screening. Study assessments are detailed in Section 8.4. | [] |
NCT04985682 | 8.3.1 | Screening Period | 8.3.1 Screening Period | [] |
NCT04985682 | 8.3.1.1 | Screening Visit | 8.3.1.1 Screening Visit The screening visit will take place within 45 days prior to the Baseline Visit on Day 0 (see Table 1 and Table 2). The study site is responsible for maintaining a screening log that includes all subjects who provided informed consent. The log also will serve to document the reason for screening ... | [] |
NCT04985682 | 8.3.1.2 | Baseline Visit (Day 0) | 8.3.1.2 Baseline Visit (Day 0) Refer to Table 1 and Table 2 for the procedures and assessments to be performed at the Baseline Visit. | [] |
NCT04985682 | 8.3.2 | Treatment Period | 8.3.2 Treatment Period The treatment period will be 6 months, starting with the Baseline Visit (Day 0) and ending with the End-of-Treatment Visit (Month 6 ± 1 week). The starting point of the treatment/observation period will be an infusion of ADVATE at the Baseline Visit to determine IR. | [] |
NCT04985682 | 8.3.2.1 | Visit 1 and Visit 2 | 8.3.2.1 Visit 1 and Visit 2 Two scheduled study visits are to be performed during the treatment period: Visit 1 at Month 1 (± 1 week) and Visit 2 at Month 3 (± 1 week). Additional unscheduled visits are also possible. For the individual assessments to be performed at each study visit, see Table 1 and Table 2. For non-c... | [] |
NCT04985682 | 8.3.2.2 | Final Visit (End-of-Treatment Visit / Study Termination Visit) | 8.3.2.2 Final Visit (End-of-Treatment Visit / Study Termination Visit) After subjects have completed 6 months of treatment on the study, the End-of-Treatment Visit will take place. Refer to Table 1 and Table 2 for the individual assessments and procedures to be performed at this visit. If subjects discontinue the study... | [] |
NCT04985682 | 8.3.3 | Follow-up Period | 8.3.3 Follow-up Period There is no follow-up period. | [] |
NCT04985682 | 8.3.4 | Additional Care of Subjects after the Study | 8.3.4 Additional Care of Subjects after the Study No aftercare is planned for this study. | [] |
NCT04985682 | 8.4 | Study Assessments | 8.4 Study Assessments | [] |
NCT04985682 | 8.4.1 | Demographic and Other Baseline Characteristics | 8.4.1 Demographic and Other Baseline Characteristics Subject demographic information including gender, age, and race will be collected prior to the subject receiving the first dose of investigational product. | [] |
NCT04985682 | 8.4.1.1 | Height and Weight | 8.4.1.1 Height and Weight Height and weight will be measured and recorded in the subject's source documents. | [] |
NCT04985682 | 8.4.1.2 | Medical and Medication History | 8.4.1.2 Medical and Medication History Medical and medication history will be collected and recorded in the subject's source documents. | [] |
NCT04985682 | 8.4.2 | Efficacy | 8.4.2 Efficacy | [] |
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