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Status unknownNCT04956328Updated Jul 26, 2021

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

A Phase 3 interventional study of Obeticholic Acid Tablets and UDCA in Primary Biliary Cirrhosis, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-26.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Primary Biliary Cirrhosis
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In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 120 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Obeticholic Acid Tablets · Drug: UDCA

  • Placebo comparator
    Placebo

    Placebo once daily in combination with UDCA for 48 weeks.

    Drug: UDCA · Drug: Placebo

Interventions

  • DrugObeticholic Acid Tablets

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

  • DrugUDCA

    UDCA：continue prestudy dose

  • DrugPlacebo

    Placebo

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What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 48 weeks

Secondary outcomes

  1. 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

    Time frame: up to 36 weeks

  2. 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)

    Time frame: up to 48 weeks

07

Study locations

1 of 1 sites recruiting
  • The first hospital of Jilin University
    Changchun, Jilin 130000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04956328
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Jul 9, 2021
Start date
Jul 22, 2021
Primary completion
Sep 20, 2023 (estimated)
Completion
Sep 20, 2023 (estimated)
Last update
Jul 26, 2021

Study contacts

Junqi Niu, Professor
Contact
junqiniu@aliyun.com
13756661205

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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