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Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis Clinical Trial

Official title:
An Open Label, Phase 2 Study to Evaluate the Effect of A3907 on Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults With Primary Sclerosing Cholangitis (PSC)

Clinical Trial 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).

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05642468
Study type Interventional
Source Ipsen
Contact Ipsen Recruitment enquiries
Phone see email
Email clinical.trials@ipsen.com
Status Recruiting
Phase Phase 2
Start date January 9, 2023
Completion date June 14, 2025
View Details
See also
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