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

Xijing Hospital of Digestive Diseases200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Primary Biliary Cirrhosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed informed consent 2. Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP \> 1,5N) and aminotransferase (AST or ALT \> 1N) activities; c.Histological hepatic injuries consistent with PBC. 3. Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response. 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.

Outcomes

Primary Outcomes

Rate of patients with complete biochemical response

Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.

Time frame: Week 24

Secondary Outcomes

Change in liver biopsy examinations compared to the baseline.

Histological evolution will be checked by liver biopsy at the end of the study to compare with baseline histological status.

Time frame: Week 48

Change in GLOBE scores after treatment.

The prognostic scores will be calculated at entry and end of study by GLOBE scoring system.

Time frame: Week 48

Change in liver stiffness status measured by magnetic resonance elastography

The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography.

Time frame: Week 48

Change in serum alkaline phosphatase (ALP) level

Change in serum levels of ALP (IU/L) compared to the baseline.

Time frame: Weeks 0, 4, 8, 12, 24, and 48

Change in serum bilirubin level

Change in serum levels of bilirubin (mg/dL) compared to the baseline

Time frame: Weeks 0, 4, 8, 12, 24, and 48

Change in serum transaminase level

Change in serum levels of transaminase (IU/L) compared to the baseline

Time frame: Weeks 0, 4, 8, 12, 24, and 48

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts