NCT02916641 is a Phase 3 clinical trial of Fuzhenghuayu in Primary Biliary Cirrhosis, sponsored by Xijing Hospital of Digestive Diseases.

Who is sponsoring NCT02916641?

NCT02916641 is sponsored by Xijing Hospital of Digestive Diseases.

What drugs are being tested in NCT02916641?

Interventions in NCT02916641: Fuzhenghuayu, UDCA.

What condition does NCT02916641 study?

NCT02916641 studies Primary Biliary Cirrhosis.

Is NCT02916641 still recruiting?

NCT02916641 is currently status unknown. Last updated 26 September 2016.

Last reviewed 2016-09-26 · How we verify

NCT02916641

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid

Status unknown Phase 3 Last updated 26 September 2016

What this trial tests

Phase 3 trial testing Fuzhenghuayu in Primary Biliary Cirrhosis in 200 participants. Status unknown.

Timeline

1 January 2016

Primary endpoint
1 December 2018

Quick facts

Lead sponsor	Xijing Hospital of Digestive Diseases
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	1 January 2016
Primary completion	1 December 2018
Sites	1 location across China

Drugs / interventions tested

Fuzhenghuayu — full drug profile →
UDCA — full drug profile →

Conditions studied

Primary Biliary Cirrhosis — all drugs for Primary Biliary Cirrhosis →

Sponsor

Xijing Hospital of Digestive Diseases

Who can join

Adults 18 to 70, any sex, with Primary Biliary Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Rate of patients with complete biochemical response
Time frame: Week 24
Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.

Sponsor's own description

Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver fibrosis might jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for liver fibrosis and cirrhosis. Both lab research and some clinical studies suggest that Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. Here we start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Primary Biliary Cirrhosis

Currently open trials in the same condition.

NCT06519162 — Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome · recruiting
NCT04526665 — Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) · Phase 3 · active not recruiting

Other Xijing Hospital of Digestive Diseases trials

Trials by the same sponsor.

NCT07401303 — Full-time RDI for ESD: Impact on Major Adverse Events and Procedure Time · NA · not yet recruiting
NCT07296458 — FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy · Phase 3 · recruiting
NCT07129460 — Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia · Phase 4 · not yet recruiting
NCT07182890 — Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia · Phase 4 · recruiting
NCT07187492 — Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02916641 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Xijing Hospital of Digestive Diseases
Last refreshed: 26 September 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02916641.

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