Autosomal Dominant Polycystic Kidney Disease (ADPKD), Patients with Increased Risk of Liver Injury
Conditions
Interventions
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
Conc
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Unwilling or unable to provide a blood sample.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Argentina, Belgium, France, Germany, Japan, United States
Contacts
Public ContactLaurie Debuque
Otsuka Pharmaceutical Development & Commercialization, Inc.
Outcome results
None listed