Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis
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|ClinicalTrials.gov Identifier: NCT03476993|
Recruitment Status : Terminated (Sponosor's decision)
First Posted : March 26, 2018
Last Update Posted : October 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis, Biliary||Biological: BCD-085||Phase 2|
This is an open-label proof-of-concept phase 2A study. The aim of the study is to evaluate the efficacy and safety of BCD-085 in combination with ursodeoxycholic acid in patients with primary biliary cholangitis (PBC) with compensated liver function with an inadequate (suboptimal) response to ursodeoxycholic acid.
In this study the inadequate (suboptimal) response to ursodeoxycholic acid (UDCA) is defined as screening alkaline phosphatase (ALP) level > 1.67 ULN (the upper limit of normal) despite treatment with UDCA in stable dose for at least 6 months before signing the ICF.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Non-comparative Study to Evaluate the Efficacy and Safety of BCD-085 (JSC BIOCAD, Russia) in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cholangitis|
|Actual Study Start Date :||April 27, 2018|
|Actual Primary Completion Date :||July 1, 2019|
|Actual Study Completion Date :||July 1, 2019|
All patients will receive BCD-085 (subcutaneous injection) in combination with ursodeoxycholic acid (UDCA) in standard dose 13-15 mg/kg/day
All patients will receive BCD-085 (subcutaneous injections) once a week during the period of induction of remission, then once every 2 weeks during the period of remission maintenance and then once every 4 weeks during the period of accumulation of treatment effect. All patients will receive ursodeoxycholic acid (UDCA) in standard dose 13-15 mg/kg/day.
- The proportion of patients with alkaline phosphatase (ALP) decrease > 40% from Baseline (day 1 week 0) or with normal ALP level (Barcelona criteria) after 24 weeks of treatment with BCD-085 in combination with UDCA. [ Time Frame: week 24 ]Biochemical response is defined as ALP decrease > 40% from Baseline or normalisation of ALP level (Barcelona criteria).
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): NCT03476993
|State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University|
|Moscow, Russian Federation|
|North-Western State Medical University named after I.I. Mechnikov|
|Saint Petersburg, Russian Federation|
|Smolensk state medical university|
|Smolensk, Russian Federation|
|Principal Investigator:||Marina Maevskaya||State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University|