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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02916641
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
Information provided by (Responsible Party):
Han Ying, Xijing Hospital of Digestive Diseases

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.

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Drug: Fuzhenghuayu Drug: UDCA Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018

Arm Intervention/treatment
Experimental: Fuzhenghuayu+UDCA
Regular UDCA treatment combination with Fuzhenghuayu
Drug: Fuzhenghuayu
Drug: UDCA
Active Comparator: Monotherapy
UDCA monotherapy
Drug: UDCA

Primary Outcome Measures :
  1. Rate of patients with complete biochemical response [ Time Frame: Week 24 ]
    Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.

Secondary Outcome Measures :
  1. 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.

  2. Change in GLOBE scores after treatment. [ Time Frame: Week 48 ]
    The prognostic scores will be calculated at entry and end of study by GLOBE scoring system.

  3. 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.

  4. 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.

  5. 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

  6. 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

Other Outcome Measures:
  1. Change in pruritus [ Time Frame: Week 24 ]
    The symptom of pruritus will be evaluated by questionnaire before enrolment and at the end of the study.

  2. Change in fatigue [ Time Frame: Week 24 ]
    The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrolment and at the end of the study.

  3. Change in serum Immunoglobulin M Levels. [ Time Frame: Week 24, ]
    Absolute and percent change in serum levels of Immunoglobulin M (g/L) compared to the baseline.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02916641

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Contact: Ying Han, Ph.D 86-29-84771539
Contact: Yongquan Shi, Ph.D 86-29-84771515

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China, Shaanxi
Xijing Hosipital of Digestive Disease Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ying Han, Ph.D    86-29-84771539   
Contact: Yongquan Shi, Ph.D    86-29-84771515   
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
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Responsible Party: Han Ying, Professor Consultant Physician, Xijing Hospital of Digestive Diseases Identifier: NCT02916641    
Other Study ID Numbers: KY20151230-7
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Keywords provided by Han Ying, Xijing Hospital of Digestive Diseases:
Additional relevant MeSH terms:
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Liver Cirrhosis, Biliary
Cholestasis, Intrahepatic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Liver Cirrhosis