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

Primary Purpose

Primary Biliary Cirrhosis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Obeticholic Acid Tablets

UDCA

Placebo

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female aged 18 to 75 years.
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.
ALP > 1.67× ULN before enrollment.
Taking UDCA with stable dose for at least 3 months before enrollment.

Exclusion Criteria:

Merging with other virus infected.
With other existing liver disease or a history of liver disease.
With clinical complications of PBC or clinically significant hepatic decompensation.
Child-pugh grade B or C.
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].
ALT or AST>5×ULN;Tbil > 2×ULN.
Patients with a history of severe pruritus 2 months before enrollment.
The presence of clinically relevant arrhythmias or associated history that may affect survival during the study period.
With diseases that may cause nonhepatic ALP increases (e.g., Paget's disease) or which may diminish life expectancy to < 2 years.

Sites / Locations

The first hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OCA Tablets 5-10 mg

Placebo

Arm Description

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.

Placebo once daily in combination with UDCA for 48 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Rate of change of liver function indicators from baseline

Liver function: ALP (alkaline phosphatase ), ALT (Alaninetransaminase), AST(aspartate transaminase), GGT( γ-glutamyl transpeptadase ), TBA (total bile acid) and Tbil (total bilirubin)

Full Information

NCT ID

NCT04956328

First Posted

July 1, 2021

Last Updated

July 23, 2021

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04956328

Brief Title

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

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 .

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 22, 2021 (Actual)

Primary Completion Date

September 20, 2023 (Anticipated)

Study Completion Date

September 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Biliary Cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OCA Tablets 5-10 mg

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo once daily in combination with UDCA for 48 weeks.

Intervention Type

Drug

Intervention Name(s)

Obeticholic Acid Tablets

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

UDCA

Intervention Description

UDCA：continue prestudy dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Description

Compound endpoint: ALP < 1.67× ULN, ALP decrease by at least 15% , and total bilirubin ≤ ULN

Time Frame

up to 48 weeks

Secondary Outcome Measure Information:

Title

Description

Compound endpoint: ALP < 1.67× ULN, ALP decrease by at least 15% , and total bilirubin ≤ ULN

Time Frame

up to 36 weeks

Title

Rate of change of liver function indicators from baseline

Description

Liver function: ALP (alkaline phosphatase ), ALT (Alaninetransaminase), AST(aspartate transaminase), GGT( γ-glutamyl transpeptadase ), TBA (total bile acid) and Tbil (total bilirubin)

Time Frame

up to 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged 18 to 75 years. Meet at least 2 of the following 3 PBC diagnoses: Patients had elevated alkaline phosphatase for at least 3 months before enrolment. AMA positive (titer ≥1:40), or if AMA negative, PBC specific antibodies (anti- GP210 and/or anti-SP100 and/or AMA-M2) are required. Liver biopsy suggested PBC 48 weeks before enrollment. ALP > 1.67× ULN before enrollment. Taking UDCA with stable dose for at least 3 months before enrollment. Exclusion Criteria: Merging with other virus infected. With other existing liver disease or a history of liver disease. With clinical complications of PBC or clinically significant hepatic decompensation. Child-pugh grade B or C. 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]. ALT or AST>5×ULN;Tbil > 2×ULN. Patients with a history of severe pruritus 2 months before enrollment. The presence of clinically relevant arrhythmias or associated history that may affect survival during the study period. With diseases that may cause nonhepatic ALP increases (e.g., Paget's disease) or which may diminish life expectancy to < 2 years.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junqi Niu, Professor

Phone

13756661205

junqiniu@aliyun.com

Facility Information:

Facility Name

The first hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Junqi Niu

Phone

13756661205

junqiniu@aliyun.com

First Name & Middle Initial & Last Name & Degree

Junqi Niu

12. IPD Sharing Statement

Learn more about this trial

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

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