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NCT02916290
Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Phase 3 trial testing Fuzhenghuayu in Primary Biliary Cirrhosis in 200 participants. Status unknown.
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 48
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 the investigators 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.
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Related trials
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)
- Trial protocol + status: ClinicalTrials.gov NCT02916290 (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/NCT02916290.
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