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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 October 2016 |
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Main ID: |
NCT02916641 |
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Date of registration:
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28/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid
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Scientific title:
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Date of first enrolment:
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January 2016 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02916641 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Ying Han, Ph.D |
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Address:
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Telephone:
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86-29-84771539 |
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Email:
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hanying@fmmu.edu.cn |
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Affiliation:
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Name:
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Ying Han, Ph.D |
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Address:
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Telephone:
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86-29-84771539 |
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Email:
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hanying@fmmu.edu.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Biliary Cirrhosis
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Intervention(s)
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Drug: Fuzhenghuayu
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Drug: UDCA
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Primary Outcome(s)
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Rate of patients with complete biochemical response
[Time Frame: Week 24]
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Secondary Outcome(s)
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Change in serum alkaline phosphatase (ALP) level
[Time Frame: Weeks 0, 4, 8, 12, 24, and 48]
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Change in serum transaminase level
[Time Frame: Weeks 0, 4, 8, 12, 24, and 48]
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Change in serum bilirubin level
[Time Frame: Weeks 0, 4, 8, 12, 24, and 48]
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Change in liver stiffness status measured by magnetic resonance elastography
[Time Frame: Week 48]
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Change in GLOBE scores after treatment.
[Time Frame: Week 48]
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Change in liver biopsy examinations compared to the baseline.
[Time Frame: Week 48]
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Secondary ID(s)
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KY20151230-7
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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