Clinical trial NCT02916641: Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Biliary Cirrhosis
Keywords: Fuzhenghuayu
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 we start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of patients with complete biochemical response
timeFrame: Week 24
Secondary outcomes:
measure: Change in liver biopsy examinations compared to the baseline.
timeFrame: Week 48
measure: Change in GLOBE scores after treatment.
timeFrame: Week 48
measure: Change in liver stiffness status measured by magnetic resonance elastography
timeFrame: Week 48
measure: Change in serum alkaline phosphatase (ALP) level
timeFrame: Weeks 0, 4, 8, 12, 24, and 48
measure: Change in serum bilirubin level
timeFrame: Weeks 0, 4, 8, 12, 24, and 48
measure: Change in serum transaminase level
timeFrame: Weeks 0, 4, 8, 12, 24, and 48
Other outcomes:
measure: Change in pruritus
timeFrame: Week 24
measure: Change in fatigue
timeFrame: Week 24
measure: Change in serum Immunoglobulin M Levels.
timeFrame: Week 24,
Locations:
city: Xi'an
country: China
facility: Xijing Hosipital of Digestive Disease
state: Shaanxi
Study officials:
References: