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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NCT03853798 | 7.3 | Number of Subjects to be Enrolled | 7.3. Number of Subjects to be Enrolled Approximately 96, with up to 116, subjects are potentially eligible to be enrolled in this extension study: approximately 76 subjects from Study AG348-C-006 and approximately 20, with up to 40, subjects from Study AG348-C-007, if eligible. | [] |
NCT03853798 | 7.4 | Modifications Allowed During Declared Public Health Emergencies and Natural Disasters | 7.4. Modifications Allowed During Declared Public Health Emergencies and Natural Disasters In the event of a declared public health emergency or natural disaster that affects a geographic area (eg, state, province, country, region, continent) and impedes adherence to protocol-specified procedures, certain modifications... | [] |
NCT03853798 | 7.4.1 | Allowable Modifications | 7.4.1. Allowable Modifications The following modifications are allowed in the event of a public health emergency or natural disaster and must be reported as protocol deviations; refer to Section 10.1 for the timing of assessments: - Alternative distribution of study drug - − A 3-month supply of AG-348 may be shipped to... | [
"o Telemedicine visits",
"e Home health study support"
] |
NCT03853798 | 7.5 | Criteria for Study Closure | 7.5. Criteria for Study Closure This study may be terminated if, in the opinion of the Sponsor, there is sufficient reasonable cause. In the event of such action, written notification documenting the reason for study termination will be provided to each Investigator. Circumstances that may warrant termination include, ... | [] |
NCT03853798 | 8 | STUDY POPULATION | 8. STUDY POPULATION | [] |
NCT03853798 | 8.1 | Inclusion Criteria | 8.1. Inclusion Criteria Subjects must meet all of the following criteria to be eligible for inclusion in this extension study: - 1. Have provided signed written informed consent prior to participating in this extension study. - 2. Have completed the antecedent AG-348 study through the Part 2 Week 24 Visit of Study AG34... | [] |
NCT03853798 | 8.2 | Exclusion Criteria | 8.2. Exclusion Criteria Subjects who meet any of the following criteria will not be enrolled in this extension study: - 1. Have a significant medical condition (including clinically significant laboratory abnormality) that developed during his/her antecedent AG-348 study that confers an unacceptable risk to participati... | [] |
NCT03853798 | 8.3 | Subject Withdrawal Criteria | 8.3. Subject Withdrawal Criteria Subjects have the right to withdraw from the study drug or the study at any time for any reason. A subject's withdrawal from study drug or the study will not jeopardize the relationship with their health care providers or affect their future care. Should a subject decide to withdraw con... | [] |
NCT03853798 | 8.3.1 | Withdrawal From Study Drug | 8.3.1. Withdrawal From Study Drug Subjects may be permanently withdrawn from study drug based on the judgment of the Investigator. Subjects who are withdrawn from study drug will be encouraged to return for the Follow-Up Visit, unless consent has been withdrawn. Subjects may be withdrawn from study drug under the follo... | [] |
NCT03853798 | 8.3.2 | 'Withdrawal From the Study | 8.3.2. 'Withdrawal From the Study Subjects will be withdrawn from the study under the following conditions: - e Withdrawal of consent - o Development of an intercurrent medical condition that precludes further participation in the study - e Development of an AE that meets the criteria for discontinuation from study dru... | [] |
NCT03853798 | 8.3.3 | Temporary Withdrawal From Study Drug for Pregnancy | 8.3.3. Temporary Withdrawal From Study Drug for Pregnancy Should a subject become pregnant during the study, the pregnancy should be reported to the Sponsor as detailed in Section 11.4, and the subject should interrupt treatment with AG-348 immediately and remain off study drug for the duration of pregnancy and breastf... | [] |
NCT03853798 | 9 | STUDY TREATMENTS | 9. STUDY TREATMENTS | [] |
NCT03853798 | 9.1 | Description of Study Drug | 9.1. Description of Study Drug Details on the study drug are provided in Table 1. Table 1: Study AG348-C-011 Investigational Product | | Investigational product | |--------------------------|-------------------------| | Product name: | AG-348 | | Dosage form: | Tablets | | Unit dose: | 5 mg, 20 mg, and 50 mg | | Route ... | [] |
NCT03853798 | 9.1.1 | Study Drug Packaging and Labeling | 9.1.1. Study Drug Packaging and Labeling AG-348 will be supplied as 5, 20, or 50 mg tablets in 35-tablet bottles with child-resistant closures and will be labeled appropriately as IMP for this study. Packaging and labeling will be prepared to meet all regulatory requirements. This is an open-label study; there are no a... | [] |
NCT03853798 | 9.1.2 | Study Drug Storage | 9.1.2. Study Drug Storage AG-348 tablets must be stored according to the respective package label. All study drug must be stored in a secure, limited-access location and may be dispensed only by the Investigator, member of the staff specifically authorized by the Investigator, or party designated to deliver study drug ... | [] |
NCT03853798 | 9.1.3 | Study Drug Administration | 9.1.3. Study Drug Administration AG-348 tablets are to be taken orally and swallowed whole with water. The tablets are not to be crushed, chewed, or dissolved in water. Doses of AG-348 may be taken with or without food. Subjects will take 1 tablet twice a day, approximately 12 hours (ie, 12 hours ± 2 hours) apart, for ... | [] |
NCT03853798 | 9.3.3 | Study Drug Discontinuation or Interruption With Recommended Dose Taper Regimen | 9.3.3. Study Drug Discontinuation or Interruption With Recommended Dose Taper Regimen Table 3: Recommended Dose Taper Regimen, Study AG348-C-011 | Starting dose(at the time of the dose taper) | First step×7 days | Second step×7 days | |--------------------------------------------------|-----------------------|---------... | [] |
NCT03853798 | 9.4 | Duration of Subject Participation | 9.4. Duration of Subject Participation | [] |
NCT03853798 | 9.4.1 | Treatment Duration | 9.4.1. Treatment Duration Subjects may continue AG-348 treatment for up to a maximum of 192 weeks in this extension study (not including the time required for completion of the recommended dose taper) until they meet study withdrawal criteria (Section 8.3) or the study is closed (Section 7.5). | [] |
NCT03853798 | 9.4.2 | End of Study | 9.4.2. End of Study The End of Study is defined as the point at which all subjects have discontinued or completed the study, are lost to follow-up, or the Study Sponsor terminates the study. | [] |
NCT03853798 | 9.4.3 | Treatment Compliance | 9.4.3. Treatment Compliance Treatment compliance will be assessed by drug accountability (ie, number of tablets dispensed vs number returned). | [] |
NCT03853798 | 9.5 | Concomitant Medications | 9.5. Concomitant Medications Concomitant medications are defined as those administered from the point of signing the informed consent form (ICF) on this extension study through the subject's completion of the study. Prior medications will have already been collected as either a prior medication or concomitant medicatio... | [] |
NCT03853798 | 9.5.1 | Prohibited Medications | 9.5.1. Prohibited Medications Concomitant use of investigational drugs is not allowed while subjects are participating in this study. All subjects must discontinue any investigational drug (except for AG-348) no less than 3 months before the start of study drug on this extension study. In vitro studies using human live... | [] |
NCT03853798 | 9.5.2 | Concomitant Therapy Requiring Careful Monitoring | 9.5.2. Concomitant Therapy Requiring Careful Monitoring The medications that fall under the categories mentioned below should be replaced with alternative treatments. If this is not possible, subjects receiving these medications should be carefully monitored. A general monitoring guideline for Investigators whose patie... | [] |
NCT03853798 | 9.5.3 | Allowed Concomitant Medications | 9.5.3. Allowed Concomitant Medications Medications other than those specified above (Section 9.5.1) are permitted during the study. All intercurrent medical conditions will be treated at the discretion of the Investigator according to acceptable local standards of medical care. Subjects may receive analgesics, anti-eme... | [] |
NCT03853798 | 9.5.4 | Concomitant Non-Drug Therapies | 9.5.4. Concomitant Non-Drug Therapies Concomitant non-drug therapies are defined as those performed from the point of signing the ICF on this extension study through the subject's completion of the study. As this is an extension study, prior non-drug therapies relevant for medical/surgical history will have been record... | [] |
NCT03853798 | 9.6 | Randomization and Blinding | 9.6. Randomization and Blinding Not applicable, as this is an open-label study in which all subjects will be treated with AG-348.  | [] |
NCT03853798 | 10 | ASSESSMENTS | 10. ASSESSMENTS | [] |
NCT03853798 | 10.1 | Schedule of Assessments | 10.1. Schedule of Assessments The schedules of assessments for Cohort 1 (through Week 24), Cohorts 2 and 3 (through Week 24), and Cohorts 1, 2, and 3 (Week 37 Day 1 through Week 193 Day 1) are provided in Table 4, Table 5, and Table 6, respectively. Subjects may transition to receiving treatment with mitapivat (the int... | [] |
NCT03853798 | 10.2 | Screening Assessments | 10.2. Screening Assessments | [] |
NCT03853798 | 10.2.1 | Informed Consent | 10.2.1. Informed Consent Informed consent will be obtained after the completion of all assessments at the subject's last visit of his/her antecedent study and, for subjects in Cohorts 1 and 2, after the subject, Investigator, and site personnel are unblinded to the Study AG348-C-006 treatment allocation (ie, AG-348 or ... | [] |
NCT03853798 | 10.2.2 | Confirmation of Eligibility | 10.2.2. Confirmation of Eligibility A subject's eligibility will be assessed by the Investigator at screening. Assessments to be performed at screening are provided in the schedule of assessments for Cohort 1 in Table 4 and for Cohorts 2 and 3 in Table 5. | [] |
NCT03853798 | 10.3 | Medical History | 10.3. Medical History Medical history will not be collected in this extension study, as this information will have already been collected as part of the antecedent study. | [] |
NCT03853798 | 10.4 | Demographics | 10.4. Demographics Demographic data will include gender and year of birth only, as other demographic data will have been collected as part of the antecedent study. | [] |
NCT03853798 | 10.5 | Assessments of Safety | 10.5. Assessments of Safety The timing of safety assessments is provided in the Schedule of Assessments (Section 10.1; Table 4, Table 5, and Table 6). Assessments of safety will include the following: - Adverse event reporting, as discussed in Section 11.1 - Concomitant medications and non-drug therapies, as discussed ... | [] |
NCT03853798 | 10.5.1 | Electrocardiogram | 10.5.1. Electrocardiogram The 12-lead ECGs should be performed after 5 minutes of recumbence and in triplicate, using the ECG machine provided by the central vendor and according to the vendor manual. For Cohort 1 only, the ECG at Week 12 will be performed before, but within the same window as, the pharmacokinetic samp... | [] |
NCT03853798 | 10.5.2 | Dual-Energy X-Ray Absorptiometry Scans | 10.5.2. Dual-Energy X-Ray Absorptiometry Scans The DXA scans of the lumbar spine and proximal femur (trochanter and inter-trochanter, which comprise the total hip and femoral neck) will be performed according to the instructions provided by the central vendor (see vendor's manual for details). The DXA scans will be tra... | [] |
NCT03853798 | 10.5.3 | Safety Laboratory Assessments | 10.5.3. Safety Laboratory Assessments All clinical laboratory evaluations are to be analyzed by a central laboratory, except for urine or serum pregnancy tests, which can be performed and analyzed by a local laboratory at scheduled visits or by home testing (urine) for tests required between scheduled visits. If result... | [] |
NCT03853798 | 10.5.4 | Menstrual Cycle Diary and Assessments of Reproductive Potential | 10.5.4. Menstrual Cycle Diary and Assessments of Reproductive Potential Menstruating female subjects will be required to fill out an electronic menstrual cycle diary according to the Schedule of Assessments (Section 10.1; Table 4 and Table 5). Subjects will record the start date, stop date, and change in characteristic... | [] |
NCT03853798 | 10.6 | Assessments of Efficacy | 10.6. Assessments of Efficacy The timing of efficacy assessments is provided in the Schedule of Assessments (Section 10.1; Table 4, Table 5, and Table 6). All clinical laboratory evaluations for efficacy are to be performed by the central laboratory. If results from a central laboratory are not available to support nec... | [] |
NCT03853798 | 10.6.1 | Hemoglobin Laboratory Assessment | 10.6.1. Hemoglobin Laboratory Assessment Hemoglobin concentrations (as part of the CBC with differential) will be collected to support efficacy (and safety) assessments.  | [] |
NCT03853798 | 10.6.2 | Transfusions | 10.6.2. Transfusions Transfusion data will be collected from signing of ICF for this extension study until completion of the study as noted in Section 9.5.4. | [] |
NCT03853798 | 10.6.3 | Additional Laboratory Assessments for Efficacy | 10.6.3. Additional Laboratory Assessments for Efficacy The following laboratory parameters will be collected for additional efficacy assessments: - RBC parameters, including reticulocyte counts and percentages - Haptoglobin - Bilirubin - LDH - EPO - Erythroferrone - Soluble transferrin receptor | [] |
NCT03853798 | 10.7 | Pharmacokinetic Assessments | 10.7. Pharmacokinetic Assessments | [] |
NCT03853798 | 10.7.1 | Blood Sample Collection | 10.7.1. Blood Sample Collection Blood samples for a full pharmacokinetic profile will be collected from subjects in Cohort 1 at the Week 12 Visit at multiple time points as specified in the Schedule of Assessments (Section 10.1; Table 4). Sparse blood samples for pharmacokinetics will be collected from subjects in Coho... | [] |
NCT03853798 | 10.7.2 | Sample Analysis | 10.7.2. Sample Analysis Pharmacokinetic samples will be analyzed for AG-348 using a validated liquid chromatography-tandem mass spectrometry method. Remaining samples may be used for analyses of AG-348 metabolism (only in subjects who have agreed to this optional analysis in the ICF).  Plasma p... | [] |
NCT03853798 | 10.9 | Health-Related Quality of Life Assessments | 10.9. Health-Related Quality of Life Assessments The timing of HRQoL assessments is provided in the Schedule of Assessments (Section 10.1; Table 4 and Table 5). The following HRQoL assessments will be performed: - PKDD: The PKDD is a 7-item PRO measure of the core signs and symptoms associated with PK deficiency in adu... | [] |
NCT03853798 | 11 | ADVERSE EVENTS | 11. ADVERSE EVENTS | [] |
NCT03853798 | 11.1 | Reporting Period for Adverse Events and Serious Adverse Events | 11.1. Reporting Period for Adverse Events and Serious Adverse Events CCI Monitoring of AEs, including frequency, severity, and characterization of SAEs, AESIs, and AEs leading to discontinuation will be conducted throughout the study. Beginning at the signing of the ICF of this extension study, all new, worsening, or o... | [] |
NCT03853798 | 11.2 | Definition of Adverse Events | 11.2. Definition of Adverse Events | [] |
NCT03853798 | 11.2.1 | Adverse Event | 11.2.1. Adverse Event A clinical AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the study drug. An AE can, therefore, be any unfavorable and unintended sign (including an ab... | [] |
NCT03853798 | 11.2.2 | Serious Adverse Event | 11.2.2. Serious Adverse Event An AE or suspected adverse reaction is considered serious if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: - Death - Life-threatening (meaning that the subject was at immediate risk of death from the reaction as it occurred; but it does no... | [] |
NCT03853798 | 11.2.3 | Adverse Events Occurring Secondary to Other Events | 11.2.3. Adverse Events Occurring Secondary to Other Events In general, AEs occurring secondary to other events (eg, cascade events or clinical sequelae) should be identified by their primary cause, with the exception of severe or serious secondary events. However, medically significant AEs occurring secondary to an ini... | [] |
NCT03853798 | 11.2.4 | Preexisting Medical Conditions | 11.2.4. Preexisting Medical Conditions Preexisting medical conditions will not be collected in this extension study, as this information will have already been collected as part of the antecedent study.  | [] |
NCT03853798 | 11.2.5 | Abnormal Laboratory Values | 11.2.5. Abnormal Laboratory Values Abnormal laboratory tests should be repeated as soon as possible for confirmation. Not every laboratory abnormality qualifies as an AE. A laboratory test result should be reported as an AE if it meets any of the following criteria: - Accompanied by clinical symptoms - Results in a cha... | [] |
NCT03853798 | 11.2.6 | Adverse Events of Special Interest | 11.2.6. Adverse Events of Special Interest CCI An AESI can be serious or nonserious. Ongoing monitoring and rapid communication (within 24 hours) by the Investigator to the Sponsor is required to allow for further characterization and reporting to regulatory authorities.   and from signs and symptoms detected... | [] |
NCT03853798 | 11.3.1 | Intensity | 11.3.1. Intensity The intensity of all AEs will be graded according to the NCI CTCAE. It is important to distinguish between SAEs and AEs with a severe intensity. An AE of severe intensity may not be considered serious. Severity is a measure of intensity, whereas seriousness is defined by the criteria in Section 11.2.2... | [] |
NCT03853798 | 11.3.2 | Relationship to Study Drug | 11.3.2. Relationship to Study Drug Relationship to study drug administration will be determined by the Investigator according to the following criteria: - Not Related: AEs will be considered related, unless they fulfill the criteria as specified below: - − Evidence exists that the AE has an etiology other than the stud... | [] |
NCT03853798 | 11.4 | Pregnancy Reporting | 11.4. Pregnancy Reporting Pregnancy is neither an AE nor an SAE, unless a complication relating to the pregnancy occurs (eg, spontaneous abortion, which may qualify as an SAE). However, any pregnancy in a participating female subject that occurs during this study or within 28 days after the last dose of study drug must... | [] |
NCT03853798 | 12 | STATISTICAL METHODS | 12. STATISTICAL METHODS | [] |
NCT03853798 | 12.1 | Analysis Sets | 12.1. Analysis Sets All subjects refers to all subjects enrolled in Study AG348-C-011. • Safety Analysis Set (SAS) is defined as all subjects who are exposed to any amount of study drug in this extension study. The SAS will be used for both efficacy and safety analyses unless otherwise specified in the detailed Statist... | [] |
NCT03853798 | 12.2 | Statistical Analysis | 12.2. Statistical Analysis | [] |
NCT03853798 | 12.2.1 | General Methods | 12.2.1. General Methods The analysis will only focus on data from this extension study (ie, not the antecedent studies). Details will be specified in the SAP. All individual subject data will be presented for all subjects in data listings. Continuous variables will be summarized using the following descriptive summary ... | [] |
NCT03853798 | 12.2.2 | Background Characteristics | 12.2.2. Background Characteristics Subject disposition, demographic and baseline characteristics, concomitant medications, study drug exposure, and other background characteristics will be summarized. All subject data will be presented in subject data listings. All summaries will be based on the SAS unless otherwise sp... | [] |
NCT03853798 | 12.2.2.1 | Subject Disposition | 12.2.2.1. Subject Disposition The number and percentage of subjects in the following categories will be summarized: - All Subjects - SAS The number and percentage of subjects in the following disposition categories will also be summarized. The percentage will be calculated based on the SAS. - Completed treatment - Prem... | [] |
NCT03853798 | 12.2.2.2 | Demographics and Baseline Characteristics | 12.2.2.2. Demographics and Baseline Characteristics Demographics and baseline characteristics will be summarized and presented for the SAS. | [] |
NCT03853798 | 12.2.2.3 | Prior and Concomitant Medications and Procedures | 12.2.2.3. Prior and Concomitant Medications and Procedures Medications used in this study will be coded using the World Health Organization Drug Dictionary Enhanced and categorized as follows: - Prior medication: not collected in this trial - Concomitant medication/procedure: medication/procedure continued or newly rec... | [] |
NCT03853798 | 12.2.3 | Study Drug Exposure and Compliance | 12.2.3. Study Drug Exposure and Compliance | [] |
NCT03853798 | 12.2.3.1 | Study Drug Exposure | 12.2.3.1. Study Drug Exposure Duration of study drug exposure is defined as follows: last dose date – first dose date + 1 day, regardless of any interruptions in dosing. If the last dose date of study drug is missing, the subject's drug discontinuation or completion date will be used for analysis purpose.  / (Expected number of tablets taken during the study) Both percentage of days on study drug and percentage of ta... | [] |
NCT03853798 | 12.3 | Efficacy Analyses | 12.3. Efficacy Analyses | [] |
NCT03853798 | 12.3.1 | Analysis for the Primary Endpoint | 12.3.1. Analysis for the Primary Endpoint Not applicable, as the study's primary endpoint is safety (Section 12.4). | [] |
NCT03853798 | 12.3.2 | Analyses for the Secondary Endpoints | 12.3.2. Analyses for the Secondary Endpoints | [] |
NCT03853798 | 12.3.2.1 | Hemoglobin-related Secondary Endpoints | 12.3.2.1. Hemoglobin-related Secondary Endpoints The number and percentage of subjects experiencing an Hb response will be summarized for Cohort 1 subjects in the SAS based on the extension study assessments. If less than 2 out of the targeted 3 assessments are available, the subject will be considered a non-responder.... | [] |
NCT03853798 | 12.3.2.2 | Change from Baseline in Markers of Hemolysis and Markers of Erythropoiesis | 12.3.2.2. Change from Baseline in Markers of Hemolysis and Markers of Erythropoiesis A summary of actual values and change from corresponding baseline at each visit will be provided. Change in markers of hemolysis will be summarized separately for Cohort 1 by Hb response status. | [] |
NCT03853798 | 12.3.2.3 | Number of Transfusion Events | 12.3.2.3. Number of Transfusion Events The number of transfusion events and number of RBC units transfused will be summarized by cohort based on the SAS and adjusted for the duration on study drug during this extension study. Transfusions received over up to 3 consecutive days will be considered as a single transfusion... | [] |
NCT03853798 | 12.3.2.4 | Patient Reported Outcome-related Endpoints | 12.3.2.4. Patient Reported Outcome-related Endpoints For PKDD and PKDIA, summary statistics will be provided based on the validated algorithm once available from Study AG348-C-006. | [] |
NCT03853798 | 12.4 | Safety Analyses | 12.4. Safety Analyses Evaluating the long-term safety and tolerability of AG-348 is the primary objective of this study. The overall safety profile of AG-348 will be assessed in terms of the following: - Treatment-emergent AEs (TEAEs), including serious TEAEs, AESIs, and TEAEs leading to dose reduction, interruption, a... | [] |
NCT03853798 | 12.4.1 | Adverse Events | 12.4.1. Adverse Events Treatment-emergent AEs will be summarized based on the SAS. For analysis purposes, AEs will be classified as TEAEs or posttreatment AEs. - TEAE: any AE that increased in severity or newly developed during the treatment-emergent period. - Posttreatment AE: any AE that increased in severity or newl... | [] |
NCT03853798 | 12.4.2 | Laboratory Assessments | 12.4.2. Laboratory Assessments A summary of actual values and change from baseline values at each visit will be provided for the continuous laboratory results in SI units based on the SAS.  Results of urinalysis and the serum and urine pregnancy tests will be listed in individual subject data l... | [] |
NCT03853798 | 12.4.3 | Bone Mineral Density Findings | 12.4.3. Bone Mineral Density Findings For bone mineral density measured by DXA scans, the actual values, T- and Z-scores, and their change from baseline values will be summarized for each scanned area and at each scheduled assessment. The number and percentage of subjects with a decrease from baseline in DXA Z-score of... | [] |
NCT03853798 | 12.4.4 | Vital Signs | 12.4.4. Vital Signs For vital signs measurements, the actual values and change from baseline values will be summarized at each scheduled assessment: systolic blood pressure (BP) and diastolic BP (mmHg), body temperature (C), and heart rate (beats per minute). | [] |
NCT03853798 | 12.4.5 | Electrocardiogram Findings | 12.4.5. Electrocardiogram Findings The average of ECG triplicates will be used for each scheduled assessment. A summary of actual values and change from baseline values will be provided at each for the following standard digital ECG measurements: PR, QRS, QT, and QT corrected for heart rate intervals (heart rate-correc... | [] |
NCT03853798 | 12.4.6 | Physical Examination | 12.4.6. Physical Examination Physical examination findings will be presented as a data listing only. | [] |
NCT03853798 | 12.5 | Pharmacokinetic/Pharmacodynamic Analyses | 12.5. Pharmacokinetic/Pharmacodynamic Analyses | [] |
NCT03853798 | 12.5.1 | Pharmacokinetic Analyses | 12.5.1. Pharmacokinetic Analyses For Cohort 1 only, the plasma pharmacokinetic parameters of AG-348 will be computed using non-compartmental methods based on observed plasma concentrations of the parent and actual sample collection times. Descriptive statistics (ie, n, mean, SD, coefficient of variation, median, minimu... | [] |
NCT03853798 | 12.6 | Sample Size and Power Considerations | 12.6. Sample Size and Power Considerations This is an extension study that plans to enroll subjects from qualifying previous studies (Study AG348-C-006 and Study AG348-C-007) who meet the eligibility requirements for this study. Approximately 96, with up to 116, subjects are potentially eligible to be enrolled in this ... | [] |
NCT03853798 | 13 | ADMINISTRATIVE REQUIREMENTS | 13. ADMINISTRATIVE REQUIREMENTS | [] |
NCT03853798 | 13.1 | Good Clinical Practices | 13.1. Good Clinical Practices The study will be conducted in accordance with the International Council for Harmonisation (ICH) for GCP and the appropriate regulatory requirement(s). The Investigator will be thoroughly familiar with the appropriate use of the study drug as described in the protocol and the IB. Essential... | [] |
NCT03853798 | 13.2 | Ethical Considerations | 13.2. Ethical Considerations The study will be conducted in accordance with ethical principles founded in the Declaration of Helsinki. The Investigator must obtain IRB/IEC approval for the investigation and must submit written documentation of the approval to the Sponsor before he or she can enroll any subject into the... | [] |
NCT03853798 | 13.3 | Subject Information and Informed Consent | 13.3. Subject Information and Informed Consent The Investigator or trained designee will ensure that the subject is given full and adequate oral and written information about the nature, purpose, possible risk, and benefit of the study. Subjects must also be notified that they are free to discontinue from the study at ... | [] |
NCT03853798 | 13.4 | Subject Confidentiality | 13.4. Subject Confidentiality To maintain subject privacy, all source documents, study drug accountability records, study reports and communications will identify the subject by the assigned subject number. The  Investigator will grant monitor(s) and auditor(s) from the Sponsor or the Sponsor's... | [] |
NCT03853798 | 13.5 | Protocol Compliance | 13.5. Protocol Compliance The Investigator will conduct the study in compliance with the protocol. Modifications to the protocol should not be made without agreement of both the Investigator and the Sponsor. Changes to the protocol will require written IRB/IEC approval/favorable opinion before implementation, except wh... | [] |
NCT03853798 | 13.6 | Data Management | 13.6. Data Management All data for the subjects recruited for the trial will be entered onto the eCRFs via an EDC system provided by the Sponsor or designee. Only authorized staff may enter data onto the eCRFs. If an entry error is made, the corrections to the eCRFs will be made according to eCRF guidelines by an autho... | [] |
NCT03853798 | 13.7 | Source Documentation and Electronic Case Report Form Completion | 13.7. Source Documentation and Electronic Case Report Form Completion Source documents will be completed for each study subject. It is the Investigator's responsibility to ensure the accuracy, completeness, and timeliness of the data reported in the subject's source document/eCRF. The source document should indicate th... | [] |
NCT03853798 | 13.8 | Direct Access to Source Data | 13.8. Direct Access to Source Data The study will be monitored by the Sponsor or the Sponsor's designee. Monitoring will be done by personal visits from a representative of the Sponsor (Site Monitor) and will include on-site review of the source documents for completeness and clarity, cross-checking with source documen... | [] |
NCT03853798 | 13.9 | Record Retention | 13.9. Record Retention The Investigator will maintain all study records according to ICH-GCP and applicable regulatory requirement(s). Records will be retained for at least 2 years after the last marketing application approval or 2 years after formal discontinuation of the clinical development of the investigational pr... | [] |
NCT03853798 | 13.10 | Liability and Insurance | 13.10. Liability and Insurance The Sponsor has subscribed to an insurance policy covering, in its terms and provisions, its legal liability for injuries caused to participating persons and arising out of this research performed strictly in accordance with the scientific protocol as well as with applicable law and profe... | [] |
NCT03853798 | 13.11 | Publication of Study Findings and Use of Information | 13.11. Publication of Study Findings and Use of Information All information regarding AG-348 supplied by the Sponsor or designee to the Investigator is privileged and confidential information. The Investigator agrees to use this information only to conduct the study and not to use it for any other purpose without expli... | [] |
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