A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis
- Conditions
- Primary Biliary CholangitisMedDRA version: 20.1Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2017-003910-16-DE
- 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 safety study.
1. Must have given written informed consent (signed and dated) and any authorizations required by local law
2. Participated in a PBC study with seladelpar
3. 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 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
Exclusion criteria are applicable only for subjects with study drug interruption greater than four weeks prior to Day 1 of the long-term safety study.
1. Treatment-related adverse event leading to study drug discontinuation in a previous PBC study with seladelpar (MBX-8025)
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 2.0 mg/dL
5. Creatine kinase above 2.5 × ULN
6. Serum creatinine above 1.5 × ULN
7. Auto-immune hepatitis
8. Primary sclerosing cholangitis
9. Known history of alpha-1-antitrypsin deficiency
10. Known history of chronic viral hepatitis
11. For females, pregnancy or breast-feeding
12. Use of colchicine, methotrexate, azathioprine or systemic steroids within two months prior to screening
13. Current use of fibrates or simvastatin
14. Current use of obeticholic acid
15. Use of an experimental or unapproved treatment for PBC 16. Use of experimental or unapproved immunosuppressant
17. 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.;Primary end point(s): Assessment of Adverse Events and Treatment Emergent Adverse Events, additional assessment of specific biochemistry and hematology results.;Timepoint(s) of evaluation of this end point: Throughout the study.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The following measures will be used:<br>Alkaline phosphatase (AP) <br>Aspartate aminotransferase (AST)<br>Alanine aminotransferase (ALT)<br>Gamma-glutamyl transferase (GGT)<br>5’nucleotidase<br>Bilirubin (Total, Conjugated, Unconjugated)<br>Bone- specific AP<br>Triglycerides (TG)<br>Total Cholesterol (TC)<br>High Density Lipoprotein Cholesterol (HDL-C)<br>Low Density Lipoprotein Cholesterol (LDL-C)<br>;Timepoint(s) of evaluation of this end point: Throughout the study.