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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Han Ying, Xijing Hospital of Digestive Diseases

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE September 27, 2016
Last Update Posted Date September 27, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 26, 2016)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Biliary Cirrhosis
Intervention  ICMJE
  • Drug: Fuzhenghuayu
  • Drug: UDCA
Study Arms  ICMJE
  • Experimental: Fuzhenghuayu+UDCA
    Regular UDCA treatment combination with Fuzhenghuayu
    Interventions:
    • Drug: Fuzhenghuayu
    • Drug: UDCA
  • Active Comparator: Monotherapy
    UDCA monotherapy
    Intervention: Drug: UDCA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 26, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02916641
Other Study ID Numbers  ICMJE KY20151230-7
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Han Ying, Xijing Hospital of Digestive Diseases
Study Sponsor  ICMJE Xijing Hospital of Digestive Diseases
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Xijing Hospital of Digestive Diseases
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP