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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 August 2022 |
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Main ID: |
EUCTR2014-001501-41-BE |
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Date of registration:
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17/12/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
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Scientific title:
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A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD) |
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Date of first enrolment:
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16/01/2016 |
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Target sample size:
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20 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001501-41 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: non-treatment, exploratory study
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Belgium
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France
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Germany
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Japan
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United States
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Contacts
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Name:
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Laurie Debuque
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Address:
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2440, Research Boulevard
20850
Rockville, MD
United States |
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Telephone:
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+16095246894 |
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Email:
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Laurie.Debuque@otsuka-us.com |
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Affiliation:
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Otsuka Pharmaceutical Development & Commercialization, Inc. |
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Name:
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Laurie Debuque
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Address:
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2440, Research Boulevard
20850
Rockville, MD
United States |
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Telephone:
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+16095246894 |
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Email:
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Laurie.Debuque@otsuka-us.com |
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Affiliation:
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Otsuka Pharmaceutical Development & Commercialization, Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Participated in tolvaptan clinical Trial 156-04-251, 156-09-290, or another tolvaptan ADPKD clinical trial.
2. Blood and/or DNA sample is not available.
3. In one of the above studies experienced either:
• A serious or non-serious hepatic or liver function test abnormality AE that led to discontinuation of trial drug and was reported by the investigator;
or
• Liver enzyme elevations as listed below, even if they did not occur simultaneously and no AE was reported:
- To qualify for blood collection for DNA extraction, either:
? • ALT or AST of at least 2 × ULN or
? • BT of at least 2 × ULN
- And/or to qualify for blood collection for PBMC isolation, either:
• Met Hy’s Law criteria (> 3 × ULN for ALT and > 2 × ULN for total
bilirubin) or
? • Maximum ALT > 7 × ULN.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Unwilling or unable to provide a blood sample.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Autosomal Dominant Polycystic Kidney Disease (ADPKD), Patients with Increased Risk of Liver Injury
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Therapeutic area: Not possible to specify
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Intervention(s)
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Trade Name: Jinarc
Pharmaceutical Form: Tablet
INN or Proposed INN: Tolvaptan
CAS Number: 150683-30-0
Current Sponsor code: Tolvaptan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1 year of trial initiation.
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Primary end point(s): The number of subjects who provide a blood sample out of the number of subjects eligible to provide a sample.
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Secondary Objective: not applicable
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Main Objective: Obtain blood samples from subjects in prior tolvaptan ADPKD
clinical trials who experienced qualifying elevated liver
enzymes for subsequent identification of potential genetic
markers and biomarkers (collectively genetic/biomarkers) for
increased risk of liver injury.
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Secondary Outcome(s)
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Secondary end point(s): Not applicable.
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Timepoint(s) of evaluation of this end point: Not applicable.
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Secondary ID(s)
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156-13-208
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Source(s) of Monetary Support
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Otsuka Pharmaceutical Development & Commercialization, Inc.
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Ethics review
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Status: Approved
Approval date: 16/01/2016
Contact:
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