NCT03476993 - Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 27, 2018

Primary Completion Date

July 1, 2019

Study Completion Date

July 1, 2019

Conditions

Liver Cirrhosis, Biliary

Interventions

BIOLOGICAL

BCD-085

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.

Trial Locations (3)

Unknown

State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University, Moscow

North-Western State Medical University named after I.I. Mechnikov, Saint Petersburg

Smolensk state medical university, Smolensk