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)

Phase 1

• Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD), Patients with Increased Risk of Liver Injury; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2014-001501-41-FR
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-15
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Secondary Objective: not applicable;Primary end point(s): The number of subjects who provide a blood sample out of the number of subjects eligible to provide a sample.;Timepoint(s) of evaluation of this end point: 1 year of trial initiation.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.