Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis
- Registration Number
- NCT05642468
- Lead Sponsor
- Albireo, an Ipsen Company
- Brief Summary
This study will test a drug called A3907 to see how safe and tolerated it is for treating people with Primary Sclerosing Cholangitis (PSC).
- Detailed Description
This study will test a drug called A3907 to see how safe and tolerated it is for treating people with Primary Sclerosing Cholangitis (PSC). Detailed Description: The primary goal of this study in participants with PSC with and without a Clinically Relevant Stricture (CRS) who are treated with A3907 is to assess the safety and tolerability of A3907 following repeat doses. Secondary goals include evaluation of the pharmacokinetic properties of A3907 (the study of how the body interacts with A3907 for the entire duration of exposure) and changes in safety parameters via laboratory testing such as liver enzymes, bile acid levels and markers of bile acid synthesis
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 30 mg (Arm 2) Ritivixibat 30mg (3x10 mg tablets) A3907 administered orally once daily for 12 weeks. 30 mg BID (Arm 3) Ritivixibat 30mg (3x10 mg tablets) A3907 administered orally Bi-daily for 12 weeks. 30 mg BID for CRS (Arm 4) Ritivixibat 30mg (3x10 mg tablets) A3907 administered orally Bi-daily for 12 weeks. 10 mg (Arm 1) Ritivixibat 10mg tablet A3907 administered orally once daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Treatment related adverse events From baseline through week 12 Number of participants with treatment related adverse events as assessed by CTCAE v 5.0
- Secondary Outcome Measures
Name Time Method Maximum observed plasma concentration and Area under the Plasma Concentration versus Time Curve (AUC) of A3907 From baseline through week 12 Change in serum and urine individual and total bile acid levels From baseline through week 12 Measurement to see change in serum and urine individual and total bile acid levels
Change in ALT, AST, gamma-glutamyltransferase (GGT), ALP and bilirubin levels From baseline through week 12 Measurement to see change in ALT, AST, gamma-glutamyltransferase (GGT), ALP and bilirubin levels
Change in serum C4 level From baseline through week 12 Measurement to see change in 7α-hydroxy-4-cholesten-3-one (C4) and fibroblast growth factor 19 (FGF-19)
Trial Locations
- Locations (8)
Centrum Medyczne INTER-MED
🇵🇱Częstochowa, Poland
Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibinskiego
🇵🇱Katowice, Poland
ID Clinic Arkadiusz Pisula
🇵🇱Mysłowice, Poland
Hopital Saint Antoine
🇫🇷Paris, France
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milan, Italy
ASST di Monza - Azienda Ospedaliera San Gerardo
🇮🇹Monza, Italy
Azienda Ospedale Università Padova
🇮🇹Padova, Italy
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain