Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Phase 3

• Conditions: Primary Biliary Cirrhosis
• Interventions: Drug: Fuzhenghuayu; Drug: UDCA

• Registration Number: NCT02916290
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-28
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-26
• Last Update Submitted: 2016-09-26
• Study First Posted: 2016-09-27
• Last Update Posted: 2016-09-27
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Signed informed consent

2. Patient with PBC defined by 2 in 3 of the following criteria:

   • Positive antimitochondrial antibody type M2;
   • Abnormal serum alkaline phosphatases (ALP > 1,5N) and aminotransferase (AST or ALT > 1N) activities;
   • Histological hepatic injuries consistent with PBC.

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Exclusion Criteria

1. Pregnancy or desire of pregnancy.
2. Breast-feeding.
3. Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis.
4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
5. History of urolithiasis, nephritis or renal failure (clearance of creatinine < 60 ml/mn).
6. Hepatotoxic drugs use before recruiting.
7. Fuzhenghuayu anaphylaxis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fuzhenghuayu+UDCA	Fuzhenghuayu	Regular UDCA treatment combination with Fuzhenghuayu
Fuzhenghuayu+UDCA	UDCA	Regular UDCA treatment combination with Fuzhenghuayu
Monotherapy	UDCA	UDCA monotherapy

Primary Outcome Measures

Name	Time	Method
Rate of patients with complete biochemical response	Week 48	Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.

Secondary Outcome Measures

Name	Time	Method
GLOBE scores.	Week 48	The prognostic scores will be calculated at end of the study by GLOBE scoring system.
Change in liver biopsy examinations compared to the baseline.	Week 48	Histological evolution will be checked by liver biopsy at the end of the study to compare with baseline histological status.
Change in serum transaminase level	Weeks 0, 4, 8, 12, 24, and 48	Change in serum levels of transaminase (IU/L) compared to the baseline.
Change in liver stiffness status measured by magnetic resonance elastography.	Week 48	The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography.
Change in serum alkaline phosphatase (ALP) level	Weeks 0, 4, 8, 12, 24, and 48	Change in serum levels of ALP (IU/L) compared to the baseline.
Change in serum bilirubin level	Weeks 0, 4, 8, 12, 24, and 48	Change in serum levels of bilirubin (mg/dL) compared to the baseline

Trial Locations

Locations (1)

Xijing Hosipital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China