A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA).

Phase 1

• Conditions: Primary Biliary Cirrhosis; MedDRA version: 19.1Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-002698-39-DE
• Lead Sponsor: CymaBay Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-30
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Must have given written informed consent (signed and dated) and any authorizations required by local law
2. 18 to 75 years old (inclusive)
3. Male or female with a diagnosis of PBC by at least two of the following criteria:
• History of AP above ULN for at least six months
• Positive AMA (Anti-Mitochondrial Antibodies) titers (>1/40 on immunofluorescence or M2 positive by ELISA) or positive PBC-specific antinuclear antibodies
• Documented liver biopsy result consistent with PBC
4. On a stable and recommended dose of UDCA for the past twelve
months
5. AP = 1.67 ULN
6.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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1. 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 on active treatment)
2. AST or ALT = 3 times ULN
3. Total bilirubin >2 times ULN
4. Auto-immune hepatitis
5. Primary sclerosing cholangitis
6. Known histroy of alpha-1-Antitrypsin deficiency
7. Known history of chronic viral hepatitis
8. Creatine kinase above ULN
9. Serum creatinine above ULN
10. For females, pregnancy or breast-feeding
11. Use of colchicine, methotrexate, azathioprine or systemic steroids in the two months preceding screening
12. Current use of fibrates, including fenofibrates or systemic steroids in
the two months preceding screening
13. Use of an experimental treatment for PBC
14. Use of an experimental or unapproved immunosuppressant
15. 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