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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NCT03911401 | 3.7 | Trial Procedures | 3.7 Trial Procedures [Table](#page-41-0) 3.7-1 shows the schedule of assessment. | Informed consentInclusion and exclusion criteriaSubject demographicsPhysical examinationVital signsandbody weightClinical laboratory tests | Screeningexaminatione○○○○○ | Baselineexamination○○ | Week 1examinationa(± 2 days)b | Week 2exami... | [] |
NCT03911401 | 3.7.1 | Schedule of Assessments | 3.7.1 Schedule of Assessments Regarding assessments to be performed by the investigator or subinvestigator, the tasks that a clinical trial associate is able to perform (eg, subject demographics survey and tasks related to clinical laboratory tests) may be performed by the clinical trial associate under the supervision... | [] |
NCT03911401 | 3.7.1.1 | Acquisition of Informed Consent | 3.7.1.1 Acquisition of Informed Consent The investigator or subinvestigator will obtain written consent from the subject's legal guardian. The investigator or subinvestigator will assign a subject identification number ([3 digit number of site ID] + subject number [S + 5 digit serial number starting from 00001]) to the... | [] |
NCT03911401 | 3.7.1.2 | Screening Examination | 3.7.1.2 Screening Examination After acquisition of informed consent, the investigator or subinvestigator will perform the following examinations, observations, and evaluations, and select subjects who meet the inclusion criteria and do not fall under any of the exclusion criteria. - Subject demographics - Physical exam... | [] |
NCT03911401 | 3.7.1.3 | Subject Demographics | 3.7.1.3 Subject Demographics The investigator or subinvestigator is to record the following information in the source document and CRF. - Date of informed consent - Sex - Date of birth - Height (unit in cm: measurement indicated as an integer value; if measurement to one decimal place is possible, then the number is to... | [] |
NCT03911401 | 3.7.1.4 | Subject Registration | 3.7.1.4 Subject Registration The investigator or subinvestigator will register all subjects in the Interactive Web Response System (IWRS). | [] |
NCT03911401 | 3.7.1.5 | Baseline Examination (2 - 30 Days After the Screening Examination) | 3.7.1.5 Baseline Examination (2 - 30 Days After the Screening Examination) The investigator or subinvestigator will perform the following examinations, observations, and evaluations, and record the results in the source document and CRF. - Confirmation of inclusion/exclusion criteria - Physical examination - Vital sign... | [] |
NCT03911401 | 3.7.1.6 | Randomization (Allocation of Investigational Medicinal Products to Subjects) | 3.7.1.6 Randomization (Allocation of Investigational Medicinal Products to Subjects) The investigator or subinvestigator will enter the necessary information for the subject's eligibility in the IWRS. On the day of the baseline examination, the subjects confirmed to be registered in the IWRS will be allocated to the 0.... | [] |
NCT03911401 | 3.7.1.7 | Between the Day After the Baseline Examination and the Day Prior to the Week 1 Examination | 3.7.1.7 Between the Day After the Baseline Examination and the Day Prior to the Week 1 Examination The investigator or subinvestigator will instruct the subject to evaluate and record the following item in the pruritus diary in relation to the most intense pruritus in the past 24 hours once daily, every day, at the sam... | [] |
NCT03911401 | 3.7.1.8 | Week 1 Examination (±2 Days) | 3.7.1.8 Week 1 Examination (±2 Days) The investigator or subinvestigator will perform the following examinations, observations, and evaluations, and record the results in the source document and CRF. - Physical examination - Vital signs and body weight - IGA - EASI - VRS for pruritus (only for subjects aged 7 14 years ... | [] |
NCT03911401 | 3.7.1.9 | Week 2 Examination (±3 Days) | 3.7.1.9 Week 2 Examination (±3 Days) The investigator or subinvestigator will perform the following examinations, observations, and evaluations, and record the results in the source document and CRF. - Physical examination - Vital signs and body weight - IGA - EASI - VRS for pruritus (only for subjects aged 7 14 years ... | [] |
NCT03911401 | 3.7.1.10 | Week 4 Examination (±3 Days) or Withdrawal Examination | 3.7.1.10 Week 4 Examination (±3 Days) or Withdrawal Examination The investigator or subinvestigator will perform the following examinations, observations, and evaluations, and record the results in the source document and CRF. Withdrawal examinations should be conducted if at all possible. - Physical examination - Vita... | [] |
NCT03911401 | 3.7.1.11 | Unscheduled Visits | 3.7.1.11 Unscheduled Visits The investigator or subinvestigator will instruct the subjects to visit the trial site if the area of affected BSA markedly enlarges. The investigator or subinvestigator will perform the following examinations, observations and evaluations, and record the results in the source document and C... | [] |
NCT03911401 | 3.7.2 | Status of Investigational Medicinal Product Administration | 3.7.2 Status of Investigational Medicinal Product Administration Details of the administration diary will be recorded in the CRF. Administration status will be recorded as poor if the frequency of IMP administration is less than 80%. The investigator or subinvestigator will confirm the status of IMP administration base... | [] |
NCT03911401 | 3.7.3 | Photograph of the Target Site | 3.7.3 Photograph of the Target Site The investigator or subinvestigator will take photographs of the target site in accordance with the photography manual. The investigator or subinvestigator will select one affected BSA (excluding the face to prevent individuals from being identified) showing the severity of IGA in th... | [] |
NCT03911401 | 3.7.4 | Severity of Atopic Dermatitis | 3.7.4 Severity of Atopic Dermatitis The investigator or subinvestigator will determine the severity [8](#page-78-0) of AD (mild, moderate, severe, or very severe) and record the result in the source document and CRF. | Table 3.7.4-1Definition of Severity of Atopic Dermatitis | | |---------------------------------------... | [] |
NCT03911401 | 3.7.5 | Efficacy Assessments | 3.7.5 Efficacy Assessments | [] |
NCT03911401 | 3.7.5.1 | Investigator's Global Assessment | 3.7.5.1 Investigator's Global Assessment The investigator or subinvestigator will evaluate skin symptoms according to IGA. [9](#page-78-0) The investigator or subinvestigator will score the severity (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical... | [] |
NCT03911401 | 3.7.5.2 | Eczema Area and Severity Index | 3.7.5.2 Eczema Area and Severity Index The investigator or subinvestigator will evaluate skin symptoms according to EASI. [10](#page-78-0) The investigator or subinvestigator will score the severity (0 - 3 points) and affected BSA (%) based on the 4 clinical signs (erythema, infiltration/papulation, excoriation, and li... | [] |
NCT03911401 | 3.7.5.3 | Verbal Rating Scale for Pruritus | 3.7.5.3 Verbal Rating Scale for Pruritus The most intense pruritus in the past 24 hours will be evaluated according to the following VRS criteria:[11](#page-79-0) - 0: None - 1: Mild - 2: Moderate - 3: Severe The investigator or subinvestigator will interview the subject during the scheduled visits after the baseline e... | [] |
NCT03911401 | 3.7.5.4 | Patient-Oriented Eczema Measure | 3.7.5.4 Patient-Oriented Eczema Measure Eczema will be evaluated according to POEM (see [Appendix 2\)](#page-81-0).[12](#page-79-0) The subjects will answer 7 questions and describe their eczema. If it is difficult to obtain answers from the subject, the subject's legal guardian will evaluate the subject's eczema and a... | [] |
NCT03911401 | 3.7.5.5 | Affected Body Surface Area | 3.7.5.5 Affected Body Surface Area The investigator or subinvestigator will draw the affected BSA (range of skin eruption with inflammation at the time of examination) on the human body drawing (see [Appendix](#page-83-0) 3 or [Appendix](#page-84-0) 4) to determine the affected areas (%) on the respective 4 body region... | [] |
NCT03911401 | 3.7.6 | Safety Assessments | 3.7.6 Safety Assessments | [] |
NCT03911401 | 3.7.6.1 | Adverse Events | 3.7.6.1 Adverse Events Refer to [Section](#page-60-0) [5,](#page-60-0) [Reporting](#page-60-0) of Adverse Events. | [] |
NCT03911401 | 3.7.6.2 | Clinical Laboratory Tests | 3.7.6.2 Clinical Laboratory Tests The investigator or subinvestigator will perform clinical laboratory tests for the following items. Date of blood and urine sampling will be recorded on the source document and CRF. | Table 3.7.6.2-1Clinical Laboratory Assessments | | |--------------------------------------------------... | [] |
NCT03911401 | 3.7.6.3 | Physical Examination | 3.7.6.3 Physical Examination The investigator or subinvestigator will assess the subject's physical condition by interview, visual examination, auscultation, or palpation. The same investigator should conduct the individual subject's physical examination by the same investigator throughout the trial period. | [] |
NCT03911401 | 3.7.6.4 | Vital Signs and Body Weight | 3.7.6.4 Vital Signs and Body Weight After the subject has rested for 3 minutes or more in principle, body temperature (measured by 0.1°C in the armpit), blood pressure (systolic/diastolic), pulse rate, and body weight (measured to one decimal place in unit of kilogram) will be measured, and the results of measurement w... | [] |
NCT03911401 | 3.7.7 | Previous Medications and Concomitant Medications | 3.7.7 Previous Medications and Concomitant Medications The investigator or subinvestigator will record in the source document and CRF the name, purpose of use, dosage per administration, frequency, route of administration, and start/end date of administration of any medications other than the IMP (excluding cosmetics) ... | [] |
NCT03911401 | 3.7.8 | End of Trial | 3.7.8 End of Trial The "end of trial date" is defined as "the last date of visit or contact" or "the date judged as terminated" for the last subject completing or withdrawing from the trial. It does not include the period for follow-up of the last subject's AEs. | [] |
NCT03911401 | 3.8 | Stopping Rules, Withdrawal Criteria, and Procedures | 3.8 Stopping Rules, Withdrawal Criteria, and Procedures | [] |
NCT03911401 | 3.8.1 | Termination or Interruption of the Entire Trial | 3.8.1 Termination or Interruption of the Entire Trial When the sponsor decides to terminate or interrupt the trial for some reason, the sponsor will promptly notify the head of the trial site and the regulatory authority in accordance with regulatory requirements. | [] |
NCT03911401 | 3.8.2 | Termination or Interruption of the Trial at Individual Trial Sites | 3.8.2 Termination or Interruption of the Trial at Individual Trial Sites Individual trial site participation may be discontinued by the sponsor, the investigator, or the IRB if judged to be necessary for medical, safety, regulatory, ethical or other reasons consistent with applicable laws, regulations, and GCP. The hea... | [] |
NCT03911401 | 3.8.3 | Individual Subject Discontinuation | 3.8.3 Individual Subject Discontinuation Any subject may discontinue participation in the trial at any time without any medical disadvantage. The investigator or subinvestigator may withdraw a subject from the trial at any time if it is considered necessary for medical treatment of that subject. | [] |
NCT03911401 | 3.8.3.1 | Treatment Discontinuation | 3.8.3.1 Treatment Discontinuation After randomization, the investigator or subinvestigator may discontinue IMP administration for various reasons. These reasons for discontinuation include a request from the subject or subject's legal guardian who is not satisfied with IMP administration or occurrence of an AE, a condi... | [] |
NCT03911401 | 3.8.3.2 | Discontinuation Criteria | 3.8.3.2 Discontinuation Criteria In any of the events listed below, the investigator or subinvestigator will discontinue IMP administration, perform the tests to be performed at withdrawal stipulated and promptly inform the sponsor of the withdrawal. The investigator or subinvestigator will record the date and reason f... | [] |
NCT03911401 | 3.8.3.3 | Documenting Reasons for Treatment Discontinuation | 3.8.3.3 Documenting Reasons for Treatment Discontinuation All subjects and subject's legal guardians have the right to discontinue the trial and the investigator or subinvestigator can also discontinue a subject's participation in the trial at any time if medically necessary. If subjects discontinue their participation... | [] |
NCT03911401 | 3.8.3.4 | Withdrawal of Consent | 3.8.3.4 Withdrawal of Consent All subjects and subjects' legal guardians have the right to withdraw their consent of trial participation at any time without any disadvantages. The subjects and the subjects' legal guardians can only withdraw their consent for future trial participation, but they cannot withdraw consent ... | [] |
NCT03911401 | 3.8.3.5 | Procedures to Encourage Continued Trial Participation | 3.8.3.5 Procedures to Encourage Continued Trial Participation If discontinuation of IMP administration or withdrawal of consent is expected, the investigator or subinvestigator will meet with the subject and the subject's legal guardian and talk about the possible options for them to continue participating (preferably,... | [] |
NCT03911401 | 3.9 | Screen Failures | 3.9 Screen Failures A screen failure subject is a subject from whom consent for trial participation has been obtained and who has a signed ICF, but who has not been randomized or to whom an IMP was not allocated. If a subject is a screen failure, the following information should be recorded in the source document and C... | [] |
NCT03911401 | 3.10 | Definition of Completed Subjects | 3.10 Definition of Completed Subjects The treatment period is defined as the time period during which subjects are evaluated for primary, secondary, and/or safety endpoints, irrespective of whether the subject actually administered all doses of IMP. Subjects who are evaluated at the last scheduled visit during the trea... | [] |
NCT03911401 | 3.11 | Definition of Subjects Lost to Follow-up | 3.11 Definition of Subjects Lost to Follow-up Subjects who cannot be contacted on and before the Week 4 examination during the treatment period, subjects who do not have a known reason for discontinuation (eg, withdrew consent or AE) and subjects whose survival is unknown on the trial completion day will be classified ... | [] |
NCT03911401 | 3.12 | Subject (including Subject's Legal Guardian) Compliance | 3.12 Subject (including Subject's Legal Guardian) Compliance - To avoid using drugs that are not permitted by the investigator or subinvestigator. - To thoroughly understand the details of the administration guidance and follow it. - To keep an administration diary every day. - The subject will evaluate the most intens... | [] |
NCT03911401 | 3.13 | Deviations from the Trial Protocol | 3.13 Deviations from the Trial Protocol In the event of a significant deviation from the protocol due to an emergency, accident, or mistake (eg, violation of informed consent process, IMP dispensing or subject dosing error, treatment assignment error, subject enrolled in violation of eligibility criteria or concomitant... | [] |
NCT03911401 | 4 | Restrictions | 4 Restrictions | [] |
NCT03911401 | 4.1 | Prohibited Concomitant Drugs and Therapies | 4.1 Prohibited Concomitant Drugs and Therapies Prohibited concomitant drugs and therapies are shown in [Table 4.1-1](#page-59-0). The use of drugs on the scalp is not restricted since the IMP will not be applied to the scalp. | Table 4.1-1Prohibited Concomitant Drugsand Therapies | | | | |------------------------------... | [] |
NCT03911401 | 5 | Reporting of Adverse Events | 5 Reporting of Adverse Events | [] |
NCT03911401 | 5.1 | Definitions | 5.1 Definitions An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Adverse Events would not include information recorded as medical history at screening for pre-planned... | [
"Immediately Reportable Event (IRE):"
] |
NCT03911401 | 5.2 | Eliciting and Reporting Adverse Events | 5.2 Eliciting and Reporting Adverse Events The investigator will periodically assess subjects for the occurrence of AEs. To avoid bias in eliciting AEs, subjects should be asked the non-leading question: "How have you felt since your last visit?" The names, dates of occurrence, dates of outcomes, seriousness, severity,... | [] |
NCT03911401 | 5.3 | Immediately Reportable Events | 5.3 Immediately Reportable Events After either the investigator, subinvestigator, or designated person becomes aware of any SAE, any AE related to occupational exposure, potential serious hepatotoxicity, or confirmed pregnancy, the investigator or subinvestigator must immediately report the event to the sponsor by e-ma... | [] |
NCT03911401 | 5.4 | Potential Serious Hepatotoxicity | 5.4 Potential Serious Hepatotoxicity For a subject who experiences an elevation in AST or ALT that is ≥3 times the upper limit of the normal range, a total bilirubin level should also be evaluated. If the total bilirubin level is ≥2 times the upper limit of the normal range, all values should be recorded on an IRE form... | [] |
NCT03911401 | 5.5 | Implementation of Patch Test | 5.5 Implementation of Patch Test If any AE suspected of hypersensitivity occurs in the treatment area, the subject will be withdrawn from the trial and given appropriate treatments. According to the following procedures, a patch test will be performed. After obtaining verbal consent to patch test from the subject's leg... | [] |
NCT03911401 | 5.6 | Pregnancy | 5.6 Pregnancy Before enrolling female children aged 7 to 14 years old in this clinical trial, the investigator or subinvestigator must review the trial participation guidelines for female children aged 7 to 14 years old. The topics should generally include: - Informed consent form - Guidelines for the follow-up of a re... | [] |
NCT03911401 | 5.7 | Procedure for Breaking the Blind | 5.7 Procedure for Breaking the Blind The investigator or subinvestigator is encouraged to contact the sponsor to discuss their rationale for unblinding. However, to prevent delays to the investigator, subinvestigator or medical personnel responding to a potentially emergent situation, unblinding of IMP will not be depe... | [] |
NCT03911401 | 5.8 | Follow-up of Adverse Events | 5.8 Follow-up of Adverse Events | [] |
NCT03911401 | 5.8.1 | Follow-up of Non-serious Adverse Events | 5.8.1 Follow-up of Non-serious Adverse Events Non-serious AEs that are identified during the trial must be recorded on the AE section of CRF with the current status noted (ongoing or recovered/resolved). All non-serious AEs (excluding IREs) that are ongoing at the day of trial completion (final observation day) will be... | [] |
NCT03911401 | 5.8.2 | Follow-up of Serious Adverse Events and Immediately Reportable Events | 5.8.2 Follow-up of Serious Adverse Events and Immediately Reportable Events In this trial, subjects will be actively observed for occurrence of any SAEs and IREs until the Week 4 examination or withdrawal examination (the day of trial completion [final observation day]). Serious Adverse Events and IREs that are identif... | [] |
NCT03911401 | 5.8.3 | Follow-up and Reporting of Serious Adverse Events and Immediately Reportable Events Occurring After Day of Trial Completion (Final Observation Day) | 5.8.3 Follow-up and Reporting of Serious Adverse Events and Immediately Reportable Events Occurring After Day of Trial Completion (Final Observation Day) Any new SAEs and IREs reported to the investigator or subinvestigator after the day of trial completion (final observation day), and are determined by the investigato... | [] |
NCT03911401 | 6 | Pharmacokinetic Analysis | 6 Pharmacokinetic Analysis No pharmacokinetic analysis is planned. | [] |
NCT03911401 | 7 | Statistical Analysis | 7 Statistical Analysis | [] |
NCT03911401 | 7.1 | Sample Size | 7.1 Sample Size The target sample size is set to achieve a power of 90% for the comparison of the 1% OPA-15406 group and vehicle group, which is firstly conducted in a closed testing procedure. In the phase 2 trial in pediatric patients in Japan (Trial 271-102-00002), the success rate in IGA was 37.5% (9/24), 40.0% (10... | [] |
NCT03911401 | 7.2 | Datasets for Analysis | 7.2 Datasets for Analysis - Safety Set (SS): The SS consists of all subjects who have received the IMP at least once. - Full Analysis Set (FAS): The FAS consists of all subjects who have received the IMP at least once. | [] |
NCT03911401 | 7.3 | Handling of Missing Data | 7.3 Handling of Missing Data For the success rate in IGA, the primary endpoint, subjects with missing IGA data will be handled as non-responders. | [] |
NCT03911401 | 7.4 | Primary and Secondary Endpoint Analyses | 7.4 Primary and Secondary Endpoint Analyses Efficacy will be analyzed in the FAS. | [] |
NCT03911401 | 7.4.1 | Primary Endpoint Analysis | 7.4.1 Primary Endpoint Analysis The primary endpoint is the success rate in IGA (percentage of subjects with an IGA score of 0 or 1 with an improvement of at least 2 grades) at Week 4. The efficacy of the 0.3% and 1% OPA-15406 groups will be demonstrated compared to the vehicle group based on the primary endpoint, the ... | [] |
NCT03911401 | 7.4.2 | Secondary Endpoint Analysis | 7.4.2 Secondary Endpoint Analysis The success rate in IGA achieving a score of 0 or 1 at Week 4 and the success rate in EASI 75, EASI 90, and EASI 50 at Week 4 The secondary endpoint will be analyzed in the same manner as the primary endpoint. For IGA, subjects who achieve a score of 0 or 1 in IGA will be handled as re... | [] |
NCT03911401 | 7.4.3 | Subgroup Analysis | 7.4.3 Subgroup Analysis Success rate in IGA by subgroup will be analyzed in the same manner as the analysis of the primary endpoint as follows: Age: 2 to 6 years old, 7 to 14 years old Sex: male, female IGA score at baseline: 2 or 3 | [] |
NCT03911401 | 7.4.4 | Exploratory Analysis of Age Factor | 7.4.4 Exploratory Analysis of Age Factor Logistic regression analysis will be performed using treatment group as the main effect, baseline IGA (2 or 3) and age as covariates, and success rate in IGA at Week 4 as a response variable. An adjusted odds ratio and its 95% confidence interval will be determined. For the age ... | [] |
NCT03911401 | 7.5 | Analysis of Demographic and Other Baseline Characteristics | 7.5 Analysis of Demographic and Other Baseline Characteristics For demographic and other baseline characteristics, the descriptive statistics or frequency distribution will be created by treatment group and for all subjects treated with OPA-15406 depending on the characteristics of the respective parameters in the FAS ... | [] |
NCT03911401 | 7.6 | Safety Analysis | 7.6 Safety Analysis Safety analysis will be performed in the SS. | [] |
NCT03911401 | 7.6.1 | Adverse Events | 7.6.1 Adverse Events All AEs will be coded using the Medical Dictionary for Regulatory Activities/Japanese version (MedDRA/J) system organ class and preferred term. The percentage of subjects experiencing the following AEs will be calculated for all subjects treated with OPA-15406 by treatment group. - TEAEs - TEAEs by... | [] |
NCT03911401 | 7.6.2 | Clinical Laboratory Tests | 7.6.2 Clinical Laboratory Tests For each parameter (except qualitative urinalysis), the descriptive statistics will be calculated for measured values and changes from the baseline at each timepoint for all subjects treated with OPA-15406 and by treatment group. For qualitative urinalysis values of clinical laboratory t... | [] |
NCT03911401 | 7.6.3 | Vital Signs and Body Weight | 7.6.3 Vital Signs and Body Weight For each parameter and body weight, the descriptive statistics will be calculated for measured values and changes from baseline at each timepoint for all subjects treated with OPA-15406 and by treatment group. The number and percentage of subjects with clinically abnormal changes will ... | [] |
NCT03911401 | 8 | Management of Investigational Medicinal Product | 8 Management of Investigational Medicinal Product For further information about the management of the IMP, refer to the Investigator's Brochure. | [] |
NCT03911401 | 8.1 | Packaging and Labeling | 8.1 Packaging and Labeling The IMP will be provided to the IMP manager, by the sponsor or designated agent. The IMP will be supplied in a packing box. Each packing box used in the treatment period will be labeled with the subject identification number, code name of the IMP, protocol number, name and address of the spon... | [] |
NCT03911401 | 8.2 | Storage | 8.2 Storage The IMP will be stored in a securely locked location. Access will be limited to the IMP manager. The IMP manager may not provide IMP to any subject not participating in this trial. The IMP will be stored at room temperature. The trial site staff will maintain a temperature log in the drug storage area by re... | [] |
NCT03911401 | 8.3 | Accountability | 8.3 Accountability The IMP manager must maintain an inventory record of IMP received, dispensed, administered, and returned. | [] |
NCT03911401 | 8.4 | Returns and Destruction | 8.4 Returns and Destruction Upon completion or termination of the trial, all unused, used and partially used IMP must be returned to the sponsor or a designated agent. All IMPs returned must be accompanied by appropriate documentation, such as storage records and be identified by protocol number with trial site number ... | [] |
NCT03911401 | 8.5 | Reporting of Product Quality Complaints | 8.5 Reporting of Product Quality Complaints A Product Quality Complaint (PQC) is any written, electronic, or verbal communication by a healthcare professional, consumer, subject, medical representative, Competent Authority, regulatory agency, partner, affiliate or other third party that alleges deficiencies or dissatis... | [] |
NCT03911401 | 8.5.1 | Eliciting and Reporting Product Quality Complaints | 8.5.1 Eliciting and Reporting Product Quality Complaints The investigator, subinvestigator, or designee must record all PQCs identified from the receipt of the IMP from the sponsor, or the sponsor's designee, up to final confirmation of destruction, including the treatment period. The investigator, subinvestigator, or ... | [] |
NCT03911401 | 8.5.2 | Information Required for Reporting Product Quality Complaints | 8.5.2 Information Required for Reporting Product Quality Complaints - Description of compliant - Reporter identification (eg, subject, investigator or subinvestigator, trial site, etc.) - Reporter contact information (eg, address, phone number, e-mail address) - ID of material (compound name, kit number) - Clinical pro... | [] |
NCT03911401 | 8.5.3 | Return Process in the Case of Product Quality Complaints | 8.5.3 Return Process in the Case of Product Quality Complaints Indicate during the PQC report if the complaint sample is available for return. The sponsor may provide instructions for the return process of the sample, as necessary. It must be documented in the site accountability record that a complaint sample has been... | [] |
NCT03911401 | 8.5.4 | Assessment/Evaluation | 8.5.4 Assessment/Evaluation Assessment and evaluation of PQCs will be handled by the sponsor. | [] |
NCT03911401 | 9 | Records Management | 9 Records Management | [] |
NCT03911401 | 9.1 | Source Documents | 9.1 Source Documents Source documents are defined as the results of original observations and activities of a clinical investigation. Source documents will include but are not limited to medical records, electronic data, screening logs, and recorded data from automated instruments. All source documents pertaining to th... | [] |
NCT03911401 | 9.2 | Data Collection | 9.2 Data Collection During each subject's visit to the clinic, a clinician participating in the trial will record medical records to document all significant observations. At a minimum, these notes will contain: - Documentation of the informed consent process, including any revised consents; - Documentation of the inve... | [] |
NCT03911401 | 9.3 | File Management at the Trial Site | 9.3 File Management at the Trial Site The heads of all trial sites will ensure that the trial site file is maintained in accordance with Section 8 of the ICH GCP Guideline E6 and as required by the applicable local regulations. The trial sites must take measures to prevent accidental or premature destruction of these d... | [] |
NCT03911401 | 9.4 | Records Retention at the Trial Site | 9.4 Records Retention at the Trial Site The trial site will retain all the trial-related documents and records for the longer of the following 2 periods. If the sponsor requires a longer period of archiving, the trial site will consult with the sponsor on the period and procedures of record retention. - A period of at ... | [] |
NCT03911401 | 10 | Quality Control and Quality Assurance | 10 Quality Control and Quality Assurance | [] |
NCT03911401 | 10.1 | Monitoring | 10.1 Monitoring The sponsor has ethical, legal, and scientific obligations to follow this trial in accordance with established research principles, the ICH GCP Guidelines (E6), and applicable regulatory requirements and local laws. As part of a concerted effort to fulfill these obligations (maintain current personal kn... | [] |
NCT03911401 | 10.2 | Auditing | 10.2 Auditing The sponsor's Quality Assurance Unit (or representative) may conduct trial site audits. Audits will include, but are not limited to, IMP supply, presence of required documents, the informed consent process, and comparison of CRFs with source documents. The investigator agrees to participate with audits. R... | [] |
NCT03911401 | 11 | Ethics and Responsibility | 11 Ethics and Responsibility This trial must be conducted in compliance with the protocol, ICH GCP Guideline (E6), international ethical principles derived from the Declaration of Helsinki and Council for International Organizations of Medical Science guidelines, and applicable local laws and regulations. Each trial si... | [] |
NCT03911401 | 12 | Confidentiality | 12 Confidentiality All information generated in this trial will be considered confidential and will not be disclosed to anyone not directly concerned with the trial without the sponsor's prior written permission. Subject confidentiality requirements of the country where the trial is conducted will be met. However, auth... | [] |
NCT03911401 | 13 | Amendment Policy | 13 Amendment Policy The investigator will not make any changes to this protocol without the sponsor's prior written consent and subsequent approval/favorable opinion by the IRB. Any permanent change to the protocol, whether an overall change or a change for specific trial site(s), must be handled as a protocol amendmen... | [] |
NCT03911401 | 14 | Publication Authorship Requirements | 14 Publication Authorship Requirements Authorship for any Otsuka-sponsored publications resulting from the conduct of this trial will be based on International Committee of Medical Journal Editors (ICMJE) authorship criteria (http://www.icmje.org/recommendations). According to ICMJE guidelines, one may be considered an... | [] |
NCT03911401 | 15 | References | 15 References - 1 Kato N, Ohya Y, Ikeda M, Ebihara T, Katayama I, Saeki H, et al. Guidelines for Management of Atopic Dermatitis 2018. The Japanese Journal of Dermatology. 2018;128(12):2431-502. - 2 Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Dermatol Suppl.1980;92:44-7. - 3 Hanifin JM, Butler J... | [
"Appendix 1 Diagnostic Criteria for Atopic Dermatitis (Japanese Dermatological Association's Criteria)",
"Differential diagnosis (association may occur)",
"Diagnostic aids",
"Clinical type (not applicable to the infantile phase)",
"facial lesions Kaposi's varicelliform eruption",
"Appendix 2 Patient-Orien... |
NCT03913130 | 1.0 | SYNOPSIS | 1.0 SYNOPSIS | Name of the Sponsor: | ProQR Therapeutics | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Objectives",
"Primary",
"Secondary",
"Endpoints",
"Primary endpoints",
"Secondary endpoints",
"LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS"
] |
NCT03913130 | 2.0 | INTRODUCTION | 2.0 INTRODUCTION ProQR Therapeutics (ProQR) is developing an antisense oligonucleotide (AON) product, QR-110, for the treatment of patients with Leber congenital amaurosis (LCA) due to the c.2991 +1655A>G mutation (p.Cys998X or IVS26+1655A>G) in the Centrosomal Protein of 290kDa (CEP290) gene. Leber congenital amaurosi... | [] |
NCT03913130 | 2.1 | Leber Congenital Amaurosis | 2.1 Leber Congenital Amaurosis Leber congenital amaurosis is a non-syndromic retinopathy that affects both cone and rod photoreceptor cells of the retina. It is a rare autosomal recessive disorder, reported to be the most severe and one of the earliest onset forms of vision loss in children, with detection of disease s... | [] |
NCT03913130 | 2.2 | QR-110 for the Treatment of Leber Congenital Amaurosis due to CEP290 p.Cys998X Mutation | 2.2 QR-110 for the Treatment of Leber Congenital Amaurosis due to CEP290 p.Cys998X Mutation The primary goal of the development plan for study drug QR-110 is to provide a treatment to overcome the genetic defect in patients with at least 1 CEP290 allele containing the p.Cys998X mutation. | [] |
NCT03913130 | 2.2.1 | Nonclinical Experience | 2.2.1 Nonclinical Experience These studies are summarized in the QR-110 Investigator's Brochure (IB), Nonclinical Studies. | [] |
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