Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
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|ClinicalTrials.gov Identifier: NCT02916290|
Recruitment Status : Unknown
Verified September 2016 by Han Ying, Xijing Hospital of Digestive Diseases.
Recruitment status was: Recruiting
First Posted : September 27, 2016
Last Update Posted : September 27, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Biliary Cirrhosis||Drug: Fuzhenghuayu Drug: UDCA||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2018|
Regular UDCA treatment combination with Fuzhenghuayu
Active Comparator: Monotherapy
- 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.
- Change in liver biopsy examinations compared to the baseline. [ Time Frame: Week 48 ]Histological evolution will be checked by liver biopsy at the end of the study to compare with baseline histological status.
- GLOBE scores. [ Time Frame: Week 48 ]The prognostic scores will be calculated at end of the study by GLOBE scoring system.
- Change in liver stiffness status measured by magnetic resonance elastography. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Weeks 0, 4, 8, 12, 24, and 48 ]Change in serum levels of transaminase (IU/L) compared to the baseline.
- Change in pruritus from baseline [ Time Frame: 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 [ Time Frame: Week 48 ]The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrollment and at the end of the study.
- Change in serum Immunoglobulin M Levels [ Time Frame: Week 48 ]Change in serum levels of Immunoglobulin M (g/L) compared to the baseline.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916290
|Contact: Ying Han, Ph.Dfirstname.lastname@example.org|
|Contact: Yongquan Shi, Ph.Demail@example.com|