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Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04483531
Expanded Access Status : Available
First Posted : July 23, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Albireo

Tracking Information
First Submitted Date July 13, 2020
First Posted Date July 23, 2020
Last Update Posted Date August 25, 2020
 
Descriptive Information
Brief Title Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
Brief Summary To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for PEDFIC 2; 2) Are not able to get to a PEDFIC 2 site for geographical reasons, and 3) Do meet the eligibility criteria for PEDFIC 2 after recruitment has been completed
Detailed Description Eligible patients will be enrolled into this expanded-access program and treated with an oral dose of 120 μg/kg/day of odevixibat and evaluated on an ongoing basis.
Study Type Expanded Access
Expanded Access Type Treatment IND/Protocol
Intervention Drug: Odevixibat
A4250 is a small molecule and selective inhibitor of IBAT
Other Name: A4250
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Clinigen Group 1-877-768-4303 Odevixibat@clinigengroup.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04483531
Responsible Party Albireo
Study Sponsor Albireo
Collaborators Not Provided
Investigators Not Provided
PRS Account Albireo
Verification Date August 2020