Primary Biliary Cirrhosis
Conditions
Keywords
Fuzhenghuayu
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.
Interventions
DRUGFuzhenghuayu
DRUGUDCA
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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. |
| GLOBE scores. | Week 48 | The prognostic scores will be calculated at end of the study by GLOBE scoring system. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in serum Immunoglobulin M Levels | Week 48 | Change in serum levels of Immunoglobulin M (g/L) compared to the baseline. |
| Change in pruritus from baseline | Week 48 | The symptom of pruritus will be evaluated by questionnaire before enrollment and at the end of the study. |
| Change in fatigue from baseline | Week 48 | The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrollment and at the end of the study. |
Countries
China
Contacts
Primary ContactYing Han, Ph.D
Backup ContactYongquan Shi, Ph.D
Outcome results
None listed