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

Primary Biliary Cirrhosis Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind Trail Evaluating the Efficacy and Safety of Combination of Obecholic Acid and UDCA Compared With UDCA Monotherapy in PBC Patients With an Inadequate Response to UDCA .

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956328
• Other study ID #: ABDS-CS-01
• Status: Recruiting
• Phase: Phase 3
• Start date: July 22, 2021
• Est. completion date: September 20, 2023

Study information

• Verified date: July 2021
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Junqi Niu, Professor
• Phone: 13756661205
• Email: junqiniu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Drug:
• Obeticholic Acid Tablets
Obeticholic Acid:Once a day (QD) by mouth (PO).
• UDCA
UDCA:continue prestudy dose
• Placebo
Placebo

Locations

Country	Name	City	State
China	The first hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of PBC patients reaching the compound endpoint after 48 weeks of treatment (Compound endpoint: alkaline phosphatase (ALP) < 1.67× Upper Limit of Normal(ULN), ALP decrease by at least 15% , and total bilirubin = ULN )	Compound endpoint: ALP < 1.67× ULN, ALP decrease by at least 15% , and total bilirubin = ULN	up to 48 weeks
Secondary	Percentage of PBC patients reaching the compound endpoint after 4 weeks, 12 weeks, 24 weeks and 36 weeks of treatment (Compound endpoint: ALP < 1.67× ULN, ALP decrease by at least 15% , and total bilirubin = ULN )	Compound endpoint: ALP < 1.67× ULN, ALP decrease by at least 15% , and total bilirubin = ULN	up to 36 weeks
Secondary	Rate of change of liver function indicators from baseline	Liver function: ALP (alkaline phosphatase ), ALT (Alaninetransaminase), AST(aspartate transaminase), GGT( ?-glutamyl transpeptadase ), TBA (total bile acid) and Tbil (total bilirubin)	up to 48 weeks