A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis
- Conditions
- Primary Biliary CholangitisMedDRA version: 21.0Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2017-003910-16-GB
- Lead Sponsor
- CymaBay Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 106
Subjects who successfully completed a previous study with seladelpar will be invited to continue their treatment in the long-term study.
1. Must have given written informed consent (signed and dated)
2. Participated in a PBC study with seladelpar and successfully completed the study
3. In the investigator’s opinion, subject derived a net benefit, from participation in a PBC study with seladelpar
4. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
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 266
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84
Exclusion criteria are applicable only for:
- subjects with study drug interruption greater than four weeks prior to Day 1 of this study.
- Subjects participated in CB8025-21838 irrespective of study drug interruption
1. Treatment-related adverse event leading to study drug discontinuation in a previous PBC study with seladelpar
2. A medical condition, other than PBC, that in the investigator’s opinion would preclude full participation in the study or confound its results (e.g., cancer)
3. AST or ALT above 3 × ULN
4. Total bilirubin above 2 x ULN
5. MELD = 15
6. Evidence of advanced PBC as defined by the Rotterdam criteria
(albumin below 1× LLN AND total bilirubin above 1 × ULN)
7. Creatine kinase above 2.5 × ULN
8. eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
9. Auto-immune hepatitis
10. Primary sclerosing cholangitis
11. Known history of alpha-1-antitrypsin deficiency
12. Known history of chronic viral hepatitis
13. For females, pregnancy or breast-feeding
14. Use of colchicine, methotrexate, azathioprine or long-term use of systemic steroids (>2 weeks) within two months prior to screening
15. Current use of fibrates
16. Current use of obeticholic acid
17. Use of an experimental or unapproved treatment for PBC 16. Use of experimental or unapproved immunosuppressant
18. Treatment with any other investigational therapy or medical device
within 30 days or within five half-lives, whatever is longer, prior to Screening
19. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study as judged by the Investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety and tolerability of seladelpar;Secondary Objective: - To evaluate the long-term efficacy of seladelpar<br>- To evaluate the effect of seladelpar on patient reported outcome (pruritus)<br>- To evaluate population pharmacokinetics and exposure-response<br>relationship of seladelpar ;Primary end point(s): Treatment Emergent Adverse Events (TEAEs) (NCI CTCAE Version 5.0),<br>biochemistry and hematology results ;Timepoint(s) of evaluation of this end point: Throughout the study
- Secondary Outcome Measures
Name Time Method