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
|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 24 ]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.
- 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02916641
|Contact: Ying Han, Ph.Dfirstname.lastname@example.org|
|Contact: Yongquan Shi, Ph.Demail@example.com|
|Xijing Hosipital of Digestive Disease||Recruiting|
|Xi`an, Shaanxi, China, 710032|
|Contact: Ying Han, Ph.D 86-29-84771539 firstname.lastname@example.org|
|Contact: Yongquan Shi, Ph.D 86-29-84771515 email@example.com|