protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT03887117 | 8.2.3 | Intensity of Adverse Event | 8.2.3 Intensity of Adverse Event The Investigator must assess the intensity of each reported AE according to the following grading scale: Mild: Easily tolerated, not interfering with normal everyday activities. Moderate: Interferes with normal everyday activities, but the subject is still able to function. Severe: Inca... | [] |
NCT03887117 | 8.2.4 | Relationship to Investigational Product and Relationship to Study Procedures | 8.2.4 Relationship to Investigational Product and Relationship to Study Procedures The Investigator must assess the causal relationship between the exposure to the IP (cigarette or IQOS) and each of the reported AEs, using the classification system and the criteria described below. The same assessment must be made sepa... | [] |
NCT03887117 | 8.2.5 | Expectedness | 8.2.5 Expectedness Any AE assessed as related to the IP (cigarette or IQOS) will be assessed for its expectedness. An AE will be regarded as "unexpected" if its nature or severity is not consistent with information already recorded about IQOS in current version of SPI. The assessment of
Confidentiality Statement P1-EX... | [
"Confidentiality Statement"
] |
NCT03887117 | 8.2.6 | Follow-up of Non-Serious and Serious Adverse Events | 8.2.6 Follow-up of Non-Serious and Serious Adverse Events Any non-serious AE that is ongoing at the time of discharge or early termination will be followed-up by the Investigator during the follow-up period until it has been resolved, stabilized (i.e., no worsening of the condition), or an acceptable explanation has be... | [] |
NCT03887117 | 8.3 | Reporting of Serious Adverse Events | 8.3 Reporting of Serious Adverse Events 
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 77 of 151 Sponsor: E-mail: @pmi.com > Phone: + 41 Address: Philip Morris Products S.A. R&D Innovation Cube 5 Quai Jeanrenaud 2000 Neuchâtel Switzerland As further information regarding ... | [
"Confidentiality Statement"
] |
NCT03887117 | 8.4 | Reporting and of Other Events Critical to Safety Evaluation | 8.4 Reporting and of Other Events Critical to Safety Evaluation | [] |
NCT03887117 | 8.4.1 | Abnormal Results of Laboratory Tests | 8.4.1 Abnormal Results of Laboratory Tests Any clinical safety laboratory test result that is outside of the normal reference range will be reviewed by the Investigator and assessed for clinical significance according to its severity. The severity of abnormal laboratory test result must be assessed using CTCAE version ... | [
"Confidentiality Statement"
] |
NCT03887117 | 8.4.2 | Reporting other abnormal findings | 8.4.2 Reporting other abnormal findings The other abnormal findings (except abnormal results of laboratory tests) discovered during different clinical assessments (e.g., ECG, spirometry, physical examination, vital signs, body weight) should be evaluated for the clinical significance by the Investigator/designee based ... | [
"Confidentiality Statement"
] |
NCT03887117 | 8.5 | Reporting and Follow-Up of Pregnancies | 8.5 Reporting and Follow-Up of Pregnancies | [] |
NCT03887117 | 8.5.1 | Period of Collection and Follow-up | 8.5.1 Period of Collection and Follow-up In case of pregnancies detected between the time of signature of the ICF and enrollment of the subject, the subject will be considered as a screening failure. In that situation, the pregnancy will not be reported to the Sponsor, however, the identified pregnancy(ies) must be cap... | [] |
NCT03887117 | 8.5.2 | Reporting of Pregnancies | 8.5.2 Reporting of Pregnancies A dedicated pregnancy form will be used to report pregnancy cases. The procedure to report a pregnancy and provide any additional/follow-up information to UBC Pharmacovigilance and Sponsor is the same and performed within the same timelines as the one described for an SAE (Section 8.3). T... | [] |
NCT03887117 | 8.6 | Adverse Events Leading to Discontinuation | 8.6 Adverse Events Leading to Discontinuation Subjects who are discontinued from the study because of an AE will undergo the early termination procedures (Section 9.6), as soon as practical after discontinuation, and will enter the 28-day safety follow-up period. In general, AEs will be followed-up until resolved,
Con... | [
"Confidentiality Statement"
] |
NCT03887117 | 8.7 | Investigational Product Malfunction and Misuse | 8.7 Investigational Product Malfunction and Misuse Any occurrences of device events, including IQOS malfunction (e.g., holder does not charge when inserted into the charger) or misuse by a subject (use not in accordance with its label and instructions), will be documented by the Investigator or his/her designee using a... | [
"Confidentiality Statement"
] |
NCT03887117 | 9 | STUDY ACTIVITIES | 9 STUDY ACTIVITIES The procedure can be performed at any time during the visit, unless otherwise specified. Assessments will be conducted only by qualified and trained site personnel. | [] |
NCT03887117 | 9.1 | Screening | 9.1 Screening The screening visit can be performed on more than one day but has to be completed (including safety laboratory results) within 28 days prior to V2. The sequence of assessments/events before VO2max test is given for illustrative purposes. The VO2max test should only be performed after all clinical assessme... | [
"Confidentiality Statement",
"Confidentiality Statement",
"Abbreviations:"
] |
NCT03887117 | 9.2 | Enrollment and Familiarization with Exercise Test | 9.2 Enrollment and Familiarization with Exercise Test Visit 2 (V2) will be scheduled 7±1 days prior to V3 (randomization). Table 6 shows the procedures that will be performed at V2.
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 84 of 151 Table 6 Time Schedule – V2 Enrollment and Exercise Capacit... | [
"Confidentiality Statement",
"Abbreviations:",
"Confidentiality Statement"
] |
NCT03887117 | 9.3 | Baseline and Randomization | 9.3 Baseline and Randomization Table 7 shows the procedures that will be performed at V3. All baseline assessments should be performed before randomization. Table 7 Time Schedule – V3 Baseline | Time | BloodSample | Procedures | Additional Information | |-------------------------------|-----------------|---------------... | [
"Confidentiality Statement",
"Confidentiality Statement",
"Abbreviations:"
] |
NCT03887117 | 9.4 | Exposure Period | 9.4 Exposure Period | [] |
NCT03887117 | 9.4.1 | Acute Effect Exercise Tests | 9.4.1 Acute Effect Exercise Tests Visit 4 (V4) will be scheduled up to 7±2 days after V3. Table 8 shows the procedures that will be performed at V4: Table 8 Time Schedule – V4 Acute Effect | Time | BloodSample | Procedures | Additional Information | |-----------------------|-----------------|---------------------------... | [
"Abbreviations:",
"Confidentiality Statement"
] |
NCT03887117 | 9.4.2 | Exercise Training Program | 9.4.2 Exercise Training Program 7±1 days after V4 all subjects besides those who are randomized to the IQOS-2 (no training) arm, will start a 12-week exercise training program, from V5 (15±2 days after V3) until V42 (99±2 days after V3) . Subjects will attend trainings sessions 2-4 times per week and three different tr... | [
"Abbreviations:",
"Confidentiality Statement",
"Confidentiality Statement",
"Abbreviations:"
] |
NCT03887117 | 9.4.3 | Training Effect Exercise Tests | 9.4.3 Training Effect Exercise Tests Visit 43 (V43) will be scheduled 106±2 days after V3, and 7±2 days after V42. Table 11 shows the procedures that will be performed at V43 Table 11 Time Schedule – V43 Training Effect Exercise Tests | Time | BloodSample | Procedures | Additional Information | |-----------------------... | [
"Confidentiality Statement"
] |
NCT03887117 | 9.5 | Safety Follow-Up Period | 9.5 Safety Follow-Up Period After the procedures of discharge or at the time of early termination, subjects will enter a 28 day safety follow-up period during which new AE/SAEs spontaneously reported by the subject and concomitant medication used as treatment for AE/SAEs will be recorded. The follow-up of ongoing AEs/S... | [] |
NCT03887117 | 9.6 | Early Termination Procedures | 9.6 Early Termination Procedures The following early termination procedures will be performed if a subject is discontinued from the study unless the subject refuses to perform the assessments: - AE/SAE recording - Device event recording - Concomitant medications - Clinical laboratory parameters (hematology, clinical ch... | [
"Confidentiality Statement",
"Confidentiality Statement"
] |
NCT03887117 | 10 | QUALITY CONTROL AND QUALITY ASSURANCE | 10 QUALITY CONTROL AND QUALITY ASSURANCE | [] |
NCT03887117 | 10.1 | Monitoring | 10.1 Monitoring The Clinical Research Associate ("Monitor") will be responsible for the monitoring of the study. Monitoring will be performed according to CRO's Standard Operating Procedures (SOPs) and as per the agreed monitoring plan with the Sponsor. The Investigator shall permit the Monitor to review study data as ... | [] |
NCT03887117 | 10.2 | Training of Collaborators | 10.2 Training of Collaborators A formal meeting (Investigator meeting) will be conducted prior to site initiation. During this meeting, the Sponsor or its authorized representative will discuss the requirements of the clinical study protocol and related documents and will also provide training in the relevant
Confiden... | [
"Confidentiality Statement"
] |
NCT03887117 | 10.3 | Audits and Inspections | 10.3 Audits and Inspections Good Clinical Practice regulations require that there are independent inspections of clinical program activities. Such inspections may be performed at any time before, during and/or after the study. Authorized representatives of the Sponsor, regulatory agencies and/or the IEC may perform aud... | [
"Confidentiality Statement"
] |
NCT03887117 | 11 | DATA MANAGEMENT ACTIVITIES | 11 DATA MANAGEMENT ACTIVITIES All Data Management activities will be described in detail in the Data Management Plan (DMP) and documents specified therein. | [] |
NCT03887117 | 11.1 | Data Capture | 11.1 Data Capture | [] |
NCT03887117 | 11.1.1 | Case Report Forms and Study Records | 11.1.1 Case Report Forms and Study Records
Data Collection Procedures: The results from the clinical assessments will be recorded in the source data file by the Investigator or their authorized designee and then captured in the CRFs. Trained study personnel will be responsible for capturing the data from the observati... | [
"Data Collection Procedures:"
] |
NCT03887117 | 11.1.2 | Protocol Deviations | 11.1.2 Protocol Deviations All protocol deviations will be entered into the Clinical Trial Management System (CTMS) or other approved format. Information from the source documents will represent the primary source of protocol deviations. Information following site monitoring and other manual reviews will be documented ... | [
"Confidentiality Statement"
] |
NCT03887117 | 11.2 | Data Handling | 11.2 Data Handling All study data will be managed by the Data Management Team at the CRO. The overall procedures for quality assurance of clinical study data are described in the SOPs of the CRO Data Management Team. The Data Management Team at CRO will prepare a DMP, to be reviewed and approved by the Sponsor, prior t... | [] |
NCT03887117 | 11.2.1 | Data Validation | 11.2.1 Data Validation The data will be validated as defined in the DMP and Data Validation Specifications. Discrepancies will be reported as defined in DMP and Data Validation Specifications. Data queries will be raised for discrepant or missing data. All changes to data will be captured in the database with a compreh... | [] |
NCT03887117 | 11.2.2 | Coding | 11.2.2 Coding AEs, medical/surgical history, and prior/concomitant medication will be classified according to the terminology of the latest version of the following Dictionaries, at time of coding the first entry: Medical history: Medical Dictionary for Regulatory Activities (MedDRA®) Adverse events / MedDRA® Procedure... | [
"Confidentiality Statement"
] |
NCT03887117 | 11.2.3 | Database Lock | 11.2.3 Database Lock When all outstanding Data Management issues have been resolved and all validation, quality review, and cleaning activities are complete, the database or selected data is/are declared soft locked. Access to change data in the soft-locked database or to change selected data at this time is limited. A... | [
"Confidentiality Statement"
] |
NCT03887117 | 12 | PLANNED STATISTICAL METHODS | 12 PLANNED STATISTICAL METHODS | [] |
NCT03887117 | 12.1 | General Considerations | 12.1 General Considerations Full details of the statistical analysis will be given in the Statistical Analysis Plan (SAP). Any changes to the planned statistical methods will be documented in the study report. The statistical evaluation will be performed using SAS®, version 9.2 or later. | [] |
NCT03887117 | 12.1.1 | Stratification Criteria | 12.1.1 Stratification Criteria For the analysis of VO2max and exercise capacity, the following stratification criteria will be used: - x Cigarette consumption at V1 (10 to 19 cigarettes, more than 19 cigarettes per day) - x Sex (male, female) Additional stratified presentations (e.g. for demographic data by age and BMI... | [] |
NCT03887117 | 12.1.2 | Definitions for Statistical Data Analysis | 12.1.2 Definitions for Statistical Data Analysis In general, baseline value for any given variable will be the last assessment prior to randomization for the subjects randomized to either IQOS, cigarette or SA arms. Further details will be described in the SAP. | [] |
NCT03887117 | 12.1.3 | Descriptive Statistics | 12.1.3 Descriptive Statistics Descriptive statistics for continuous variables will include the number of subjects, number and percent of subjects with missing data, the mean and standard deviation, geometric means and coefficient of variation (CV), median, first and third quartiles, minimum and maximum, and 95% confide... | [] |
NCT03887117 | 12.1.4 | Handling of Missing Values and of Values outside the Detection or Quantification Limits | 12.1.4 Handling of Missing Values and of Values outside the Detection or Quantification Limits For laboratory parameters outside the limit of detection or quantification, the following imputation will be performed:
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 102 of 151 - x Values below the low... | [
"Confidentiality Statement"
] |
NCT03887117 | 12.1.5 | Significance Level for Inferential Analysis | 12.1.5 Significance Level for Inferential Analysis This study is of exploratory in nature and therefore no statistical hypothesis will be tested. | [] |
NCT03887117 | 12.2 | Determination of Sample Size and Power Consideration | 12.2 Determination of Sample Size and Power Consideration The sample size of 20 per arm (smoking abstinence with training, IQOS with training, continued cigarette smoking with training) was determined based on previously published results, which reported a standard deviation of 14 mL/kg/min in VO2max in the change betw... | [
"Confidentiality Statement"
] |
NCT03887117 | 12.3 | Product Use | 12.3 Product Use Although subjects are being requested to use solely the product allocated to their respective study arm, it is considered that not all subjects randomized to the IQOS arms or to the cigarette arm will exclusively use the randomized product at all times during the study. Subjects may concomitantly use I... | [] |
NCT03887117 | 12.4 | Analysis Populations | 12.4 Analysis Populations The main population for non-safety analysis will be the As Exposed Exercise Compliant Set. Safety will be analyzed using the Safety Set. | [] |
NCT03887117 | 12.4.1 | As Exposed Exercise Compliant Set | 12.4.1 As Exposed Exercise Compliant Set The As Exposed Exercise Compliant Set (AEECS) consists of all randomized subjects who have at least one valid non-safety assessment after randomization, specifically we have - x post-randomization product (cigarette or IQOS) use experience if randomized to IQOS, IQOS-2 or cigare... | [] |
NCT03887117 | 12.4.2 | Full Analysis Set | 12.4.2 Full Analysis Set The Full Analysis Set (FAS) consists of all randomized subjects who have at least one postrandomization product (cigarette or IQOS) use experience if randomized to IQOS, IQOS-2 or cigarette arm, and who have at least one valid non-safety assessment after randomization. All subjects in the SA ar... | [
"Confidentiality Statement"
] |
NCT03887117 | 12.4.3 | Safety Set | 12.4.3 Safety Set The Safety Set consists of all subjects enrolled with signed ICF who have at least one valid safety assessment during the course of the study. The Safety Set will be analyzed by actual exposure (product use exposure). | [] |
NCT03887117 | 12.5 | Endpoint Analysis | 12.5 Endpoint Analysis To evaluate changes in VO2max in subjects switching to IQOS, continuing to smoke cigarettes and being smoking abstinent. A linear mixed effects model will be used to estimate the difference in VO2max between each arm (SA arm, IQOS-1 arm) versus cigarette arm one week after randomization (V4) and ... | [
"Confidentiality Statement",
"Confidentiality Statement"
] |
NCT03887117 | 12.6 | Demographics and Baseline Characteristics | 12.6 Demographics and Baseline Characteristics Demographic and other baseline characteristics will be summarized as reported in Section 12.1.3 for the Full Analysis Set. Summaries will also be provided for other analysis sets if they differ from FAS and each other. There will be no formal comparison of baseline data, t... | [] |
NCT03887117 | 12.7 | Interim Analysis | 12.7 Interim Analysis No interim analysis will be performed for this study.
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 107 of 151 | [
"Confidentiality Statement"
] |
NCT03887117 | 13 | ADMINISTRATIVE CONSIDERATIONS | 13 ADMINISTRATIVE CONSIDERATIONS | [] |
NCT03887117 | 13.1 | Investigator's and Study Administrative Structure | 13.1 Investigator's and Study Administrative Structure | [] |
NCT03887117 | 13.1.1 | Investigator | 13.1.1 Investigator  | [] |
NCT03887117 | 13.1.2 | Sponsor | 13.1.2 Sponsor | Sponsor: | Philip Morris Products S.A.Quai Jeanrenaud 52000 NeuchâtelSwitzerland | |------------------------|-----------------------------------------------------------------------------------| | | Tel: +41 58 242 2111Fax: +41 58 242 2811 | | Clinical Scientist | Phone: +41E-mail: | | Biostatistician |... | [] |
NCT03887117 | 13.1.3 | Other Responsibilities | 13.1.3 Other Responsibilities Any SAEs or pregnancies will be handled by:
Confidentiality Statement P1-EXC-01-EU Version 3.0 / 2 May 2019 Page 108 of 151  Any SAEs or pregnancies will be handled as per the instructions listed in Section 8.3. | [
"Confidentiality Statement"
] |
NCT03887117 | 13.2 | Subject Confidentiality | 13.2 Subject Confidentiality All information obtained during the conduct of the study with respect to the subjects and state of their health will be regarded as confidential. A statement to this effect will be written in the information provided to the subject. An agreement to disclose any such information will be obta... | [] |
NCT03887117 | 13.3 | Access to Source Documentation | 13.3 Access to Source Documentation Subjects will be informed that, during the course of the clinical study, the Sponsor, any authorized representatives of the Sponsor, IEC, or regulatory authorities may inspect their medical records to verify the information collected, and ensure that all personal information made ava... | [
"Confidentiality Statement"
] |
NCT03887117 | 13.4 | Record Retention | 13.4 Record Retention Essential study documents/records, which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced, are described in Section 8 of the ICH GCP Guidelines (3). Essential documents must be retained by the Investigator for a minimum of: x At least 1... | [
"Confidentiality Statement"
] |
NCT03887117 | 13.5 | Clinical Study Report | 13.5 Clinical Study Report The Sponsor must ensure that a CSR for this study is prepared regardless of whether the study is completed or prematurely terminated. The CSR will be written based on standards of the ICH Guideline for the Structure and Content of Clinical Study Reports. In certain circumstances, an abbreviat... | [] |
NCT03887117 | 13.6 | Financial Disclosure | 13.6 Financial Disclosure Investigators are required to provide financial disclosure information to the Sponsor. In addition, the Investigators must provide to the Sponsor a commitment to promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the c... | [] |
NCT03887117 | 13.7 | Publication and Disclosure Policy | 13.7 Publication and Disclosure Policy This document contains data, information and trade secretes that are confidential and proprietary to the Sponsor. This document is being provided solely for the purpose of evaluation and/or conducting this clinical study for the Sponsor. Disclosure of the content of
Confidentiali... | [
"Confidentiality Statement"
] |
NCT03887117 | 13.8 | Insurance | 13.8 Insurance The Sponsor is responsible for AEs and health damage of the subjects who are associated with the IQOS product which are used during the study, except for AEs and health damage of the subjects caused by a negligent or an intentional misconduct and/or significant deviation to the protocol of the Investigat... | [
"Confidentiality Statement"
] |
NCT03887117 | 14 | REFERENCE LIST | 14 REFERENCE LIST - 1. Jacobs RA, Fluck D, Bonne TC, Burgi S, Christensen PM, Toigo M, et al. Improvements in exercise performance with high-intensity interval training coincide with an increase in skeletal muscle mitochondrial content and function. J Appl Physiol (1985). 2013;115(6):785- 93. Epub 2013/06/22. doi: 10.1... | [
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"Confidentiality Statement",
"Confidentiality Statement",
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"Confidentiality Statement",
"Appendix 1 SCHEDULE OF EVENTS",
"Confidentiality Statement",
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NCT03888482 | 1 | GLOSSARY OF TERMS | 1 GLOSSARY OF TERMS | | Alcon - Business Use Only Effective Date: 08-Mar-2019Document: TDOC-0056081 Version: .0;: CURRENT; Most-Recent; Effective | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03888482 | 2 | LIST OF ACRONYMS AND ABBREVIATIONS | 2 LIST OF ACRONYMS AND ABBREVIATIONS | Alcon - Business Use OnlyDocument: TDOC-0056081 | Effective Date: 08-Mar-2019 | |-----------------------------------------------------|------------------------------------------------------------------------| | | Version: 1.0: CURRENT;Most-Recent; Effective | | LIST OF2 | ACRONYMS... | [] |
NCT03888482 | 3 | PROTOCOL SUMMARY | 3 PROTOCOL SUMMARY | PROTOCOL | SUMMARY | | |------------------------|--------------------------------------------------------------------|--| | 3 | | | | Investigational Device | | | | product type | | | | | | | | Study type | Interventional | | | Investigational | Test Product: DDT2Contact Lens (Verofilcon A) (LID006... | [
"Data analysis and sample size justification Planned Analysis To address theprmar objectives, planned analyses are summarized below: Endpoint Comparison Statistical Method",
"Sample Size Justification"
] |
NCT03888482 | 4 | PROTOCOL AMENDMENTS | 4 PROTOCOL AMENDMENTS Modification of the protocol is prohibited without prior written agreement in the form of a protocol amendment. All amendments must be created by the Study Sponsor and must be approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to implementation except when req... | [] |
NCT03888482 | 4.1 | Amendments | 4.1 Amendments There are no amendments. This 1s the first version of the protocol. | [] |
NCT03888482 | S | INTRODUCTION | S INTRODUCTION
5.1 Rationale and Background A recent paper has demonstrated that soft contact lenses continue to dominate contact lens prescribing and 1n the year 2018, soft contact lenses accounted for over 90% of lens fits. (Morgan 2019). Furthermore, 1t was reported that almost 32% of soft contact lenses were presc... | [
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"7 INVESTIGATIONAL PLAN",
"7.1 Study Design",
"7.2 Rationale for Study Design",
"7.3 Rationale for Duration of Treatment/Follow-Up",
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NCT03905512 | A | STUDY TO COMPARE THE EFFICACY OF SEL-212 TO KRYSTEXXA® IN GOUT PATIENTS REFRACTORY TO CONVENTIONAL THERAPY | A STUDY TO COMPARE THE EFFICACY OF SEL-212 TO KRYSTEXXA® IN GOUT PATIENTS REFRACTORY TO CONVENTIONAL THERAPY | | Sponsor | SelectaBiosciences | | |------------|---------|-----------------------------------|------------| | | | 65 Grove Street | | | | | Watertown,MA02472,USA | | | | | Tel: | | | | | Fax: | | | Approvers:... | [
"SELECTA BIOSCIENCES CLINICAL STUDY PROTOCOL"
] |
NCT03905512 | A | STUDY TO COMPARE THE EFFICACY OF SEL-212 TO KRYSTEXXA® IN GOUT PATIENTS REFRACTORY TO CONVENTIONAL THERAPY | A STUDY TO COMPARE THE EFFICACY OF SEL-212 TO KRYSTEXXA® IN GOUT PATIENTS REFRACTORY TO CONVENTIONAL THERAPY STUDY NUMBER: SEL-212/202
CONTACT INFORMATION | Sponsor: | SelectaBiosciences | |------------------------------|----------------------------------------------------| | | 65 Grove Street | | | Watertown,MA02472 ... | [
"CONTACT INFORMATION",
"INVESTIGATOR'S AGREEMENT"
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NCT03905512 | I | agree: | I agree: - To assume responsibility for the proper conduct of the study at this site. - To conduct the study in compliance with applicable regulatory requirements, this protocol, any future amendments, and with any other study conduct procedures provided by Selecta Biosciences. (Sponsor). - Not to implement any changes... | [
"Hence, I:",
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"Name of Sponsor/Company:",
"Name of Investigational Product:",
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"KRYSTEXXA® (pegloticase)",
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NCT03907241 | 1 | INTRODUCTION | 1 INTRODUCTION | [] |
NCT03907241 | 1.1 | Background | 1.1 Background The primary therapeutic use of γ-immunoglobulins (IgG) is to provide antibodies to prevent viral and bacterial diseases (replacement therapy) in patients with primary immunodeficiency (PI) syndromes who have significant defects of antibody formation (humoral immunity). The PI syndromes are a heterogeneou... | [] |
NCT03907241 | 1.2 | Rationale for Conducting the Study | 1.2 Rationale for Conducting the Study The administration of immunoglobulins via the SC route offers several advantages over IV infusion from a patient's and a physician's perspective. Replacement therapy by rapid SC infusion with a pump was introduced during the late 1980s. Several reports have shown that the SC metho... | [] |
NCT03907241 | 1.3 | Benefit-Risk Statement | 1.3 Benefit-Risk Statement Patients with PI need life-long treatment with immunoglobulins. Replacement therapy is expected to achieve protective trough levels of 5–6 g/L. Standard measures are taken to prevent infections resulting from the use of medicinal products prepared from human blood or plasma. Despite this, whe... | [] |
NCT03907241 | 2 | STUDY OBJECTIVES | 2 STUDY OBJECTIVES | [] |
NCT03907241 | 2.1 | Primary Objective | 2.1 Primary Objective The primary objective of the study is to assess the medium-to-long-term safety and tolerability of octanorm. | [] |
NCT03907241 | 2.2 | Secondary Objectives | 2.2 Secondary Objectives The secondary objectives of the study are: - To assess the effect of octanorm on quality-of-life measures. - To obtain further data on the efficacy of octanorm. | [] |
NCT03907241 | 3 | INVESTIGATIONAL PLAN | 3 INVESTIGATIONAL PLAN | [] |
NCT03907241 | 3.1 | Primary and Secondary Endpoints | 3.1 Primary and Secondary Endpoints | [] |
NCT03907241 | 3.1.1 | Primary Endpoint | 3.1.1 Primary Endpoint There is no single primary endpoint in this present extension study. The primary objective is to assess safety and tolerability in medium-to-long-term administration, and this will be assessed by means of the following variables: - Occurrence of all treatment-emergent AEs (TEAEs) throughout the e... | [] |
NCT03907241 | 3.1.2 | Secondary Endpoints | 3.1.2 Secondary Endpoints Secondary assessment criteria will be for quality of life and efficacy: - QoL assessments using the CHQ-PF50 from parent or guardian of patients <14 years of age and the SF-36 Health Survey in patients ≥14 years of age. - Occurrence of serious bacterial infections (SBIs) as defined in Section ... | [] |
NCT03907241 | 3.2 | Overall Study Design and Plan | 3.2 Overall Study Design and Plan The study is a prospective, open-label, non-controlled, single-arm, multicentre phase III safety study with observation of patients receiving weekly doses of octanorm over a period of up to two and half years. The study will be conducted at study sites in the United States and in Canad... | [
"SCGAM-01 patients only:"
] |
NCT03907241 | 3.3 | Discussion of Study Design and Choice of Control Group(s) | 3.3 Discussion of Study Design and Choice of Control Group(s) | [] |
NCT03907241 | 3.3.1 | Study Design | 3.3.1 Study Design The designs of the main study SCGAM-01 and of this extension study take into account the FDA's comments and requests included in the clinical hold letter (dated April 27, 2012) for IND 15019 for another SCIG of Octapharma (gammanorm 16.5%). The study design is also in line with similar study protocol... | [] |
NCT03907241 | 3.3.2 | Dosing | 3.3.2 Dosing
SCGAM-01 patients (United States, Canada): The patients will continue receiving the same octanorm dose (in mg per kg body weight) as was administered at the Week 64 infusion of the SCGAM-01-study.
De novo patients (Canada only): The patients will continue receiving the same octanorm dose (in mg per kg bo... | [
"SCGAM-01 patients (United States, Canada):",
"De novo patients (Canada only):"
] |
NCT03907241 | 3.3.3 | Control Group(s) | 3.3.3 Control Group(s) Does not apply in this study: all patients will receive active treatment with octanorm. | [] |
NCT03907241 | 3.3.4 | Target Parameters | 3.3.4 Target Parameters The outcome measures in this study are consistent with previous studies of other IVIG or SCIG products and are also in compliance with the FDA Guidance for Industry[.\[22\]](#page-50-5) The QoL Questionnaires are standardised, validated instruments that have been widely used in clinical studies,... | [] |
NCT03907241 | 3.3.5 | Statistical Considerations | 3.3.5 Statistical Considerations The FDA Guidance for Industry suggests that, based on historical data, a statistical demonstration of a serious infection rate per person-year less than 1.0 is adequate to provide substantial evidence of efficacy[.\[22\]](#page-50-5) Therefore, the 99% CI for this rate will be calculate... | [] |
NCT03907241 | 4 | STUDY POPULATION | 4 STUDY POPULATION | [] |
NCT03907241 | 4.1 | Population Base | 4.1 Population Base Approximately 45 male or female patients suffering from PI will be eligible for inclusion to this clinical study. | [] |
NCT03907241 | 4.1.1 | Inclusion Criteria | 4.1.1 Inclusion Criteria Patients who meet of the following criteria may be enrolled: Either:
SCGAM-01 patients (United States, Canada): 1 Completion of the main study SCGAM-01, with good tolerance of octanorm (as determined by the investigator). Or:
De novo patients (Canada only): - 1C-a Age of ≥18 years and ≤75 yea... | [
"SCGAM-01 patients (United States, Canada):",
"De novo patients (Canada only):"
] |
NCT03907241 | 4.1.2 | Exclusion Criteria | 4.1.2 Exclusion Criteria Patients who meet one (or more) of the following criteria are excluded from the study: Either:
SCGAM-01 patients (United States, Canada): 1 Subject being without any IgG treatment for period greater than 5 weeks between the last infusion of octanorm in the SCGAM-01 study and the first infusion... | [
"SCGAM-01 patients (United States, Canada):",
"De novo patients (Canada only):",
"And:"
] |
NCT03907241 | 4.2 | Prior and Concomitant Therapy | 4.2 Prior and Concomitant Therapy Details of any PID relevant concomitant medication (antibiotics, corticosteroids, premedication (if used), immunosuppressive or immunomodulatory drugs, blood or any blood product or derivative, IVIG, SCIG other than octanorm taken within 8 weeks before the SCGAM-03 study etc.) must be ... | [
"SCGAM-01 patients only (United States, Canada):"
] |
NCT03907241 | 4.2.1 | Permitted Concomitant Therapy | 4.2.1 Permitted Concomitant Therapy Local anaesthetics (Emla or L-Max (lidocaine) cream, plaster, or similar product) to reduce pain associated with needle insertion are allowed. The use of such medication(s) must be recorded. Routine premedication to alleviate potential tolerability problems is not allowed during the ... | [] |
NCT03907241 | 4.2.2 | Forbidden Concomitant Therapy | 4.2.2 Forbidden Concomitant Therapy Treatment with any IMP (other than IgG products) within 3 months before first infusion of octanorm in SCGAM-03 study, or during the study, is forbidden. Administration of any blood- or plasma-derived product is forbidden during the study and should only be given for emergency reasons... | [] |
NCT03907241 | 4.3 | Withdrawal and Replacement of Patients | 4.3 Withdrawal and Replacement of Patients | [] |
NCT03907241 | 4.3.1 | Premature Patient Withdrawal | 4.3.1 Premature Patient Withdrawal Patients have the right to withdraw from the study at any time for any reason, without the need to justify. The responsible Investigator also has the right to withdraw patients from the study in case of AEs, poor compliance, or administrative reasons. Reasons for premature patient wit... | [] |
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