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

Primary Biliary Cirrhosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02916641
• Other study ID #: KY20151230-7
• Status: Recruiting
• Phase: Phase 3
• First received: January 28, 2016
• Last updated: September 26, 2016
• Start date: January 2016

Study information

• Verified date: September 2016
• Source: Xijing Hospital of Digestive Diseases
• Contact: Ying Han, Ph.D
• Phone: 86-29-84771539
• Email: hanying[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Drug:
• Fuzhenghuayu

• UDCA

Locations

Country	Name	City	State
China	Xijing Hosipital of Digestive Disease	Xi`an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in pruritus	The symptom of pruritus will be evaluated by questionnaire before enrolment and at the end of the study.	Week 24	No
Other	Change in fatigue	The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrolment and at the end of the study.	Week 24	No
Other	Change in serum Immunoglobulin M Levels.	Absolute and percent change in serum levels of Immunoglobulin M (g/L) compared to the baseline.	Week 24,	No
Primary	Rate of patients with complete biochemical response	Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.	Week 24	No
Secondary	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.	Week 48	No
Secondary	Change in GLOBE scores after treatment.	The prognostic scores will be calculated at entry and end of study by GLOBE scoring system.	Week 48	No
Secondary	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.	Week 48	No
Secondary	Change in serum alkaline phosphatase (ALP) level	Change in serum levels of ALP (IU/L) compared to the baseline.	Weeks 0, 4, 8, 12, 24, and 48	No
Secondary	Change in serum bilirubin level	Change in serum levels of bilirubin (mg/dL) compared to the baseline	Weeks 0, 4, 8, 12, 24, and 48	No
Secondary	Change in serum transaminase level	Change in serum levels of transaminase (IU/L) compared to the baseline	Weeks 0, 4, 8, 12, 24, and 48	No