Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-22

Study Completion Date

2023-09-20

Brief Summary

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Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. Conventional therapy with obecholic acid will improve liver function of patients with PBC.

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Detailed Description

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Conditions

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Primary Biliary Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OCA Tablets 5-10 mg

OCA 5 mg once daily in combination with UDCA for 24 weeks and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.

Group Type EXPERIMENTAL

Obeticholic Acid Tablets

Intervention Type DRUG

Obeticholic Acid：Once a day (QD) by mouth (PO).

UDCA

Intervention Type DRUG

UDCA：continue prestudy dose

Placebo

Placebo once daily in combination with UDCA for 48 weeks.

Group Type PLACEBO_COMPARATOR

UDCA

Intervention Type DRUG

UDCA：continue prestudy dose

Placebo

Intervention Type DRUG

Placebo

Interventions

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Obeticholic Acid Tablets

Obeticholic Acid：Once a day (QD) by mouth (PO).

Intervention Type DRUG

UDCA

UDCA：continue prestudy dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female aged 18 to 75 years.
2. Meet at least 2 of the following 3 PBC diagnoses:

1. Patients had elevated alkaline phosphatase for at least 3 months before enrolment.
2. AMA positive (titer ≥1:40), or if AMA negative, PBC specific antibodies (anti- GP210 and/or anti-SP100 and/or AMA-M2) are required.
3. Liver biopsy suggested PBC 48 weeks before enrollment.
3. ALP \> 1.67× ULN before enrollment.
4. Taking UDCA with stable dose for at least 3 months before enrollment.

Exclusion Criteria

1. Merging with other virus infected.
2. With other existing liver disease or a history of liver disease.
3. With clinical complications of PBC or clinically significant hepatic decompensation.
4. Child-pugh grade B or C.
5. Creatinine (Cr) ≥ 1.5×ULN and serum creatinine clearance rate \< 60mL/min; \[Calculation formula: Cr:(140-age)×weight(kg) /0.818 × Scr (μmol/L)，female Cr=Cr × 0.85\].
6. ALT or AST\>5×ULN;Tbil \> 2×ULN.
7. Patients with a history of severe pruritus 2 months before enrollment.
8. The presence of clinically relevant arrhythmias or associated history that may affect survival during the study period.
9. With diseases that may cause nonhepatic ALP increases (e.g., Paget's disease) or which may diminish life expectancy to \< 2 years.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No