Trials / Approved For Marketing
Approved For MarketingNCT04483531
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
Odevixibat (A4250) for the Treatment of Progressive Familial Intrahepatic Cholestasis (Expanded Access Program)
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Albireo · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Odevixibat | A4250 is a small molecule and selective inhibitor of IBAT |
Timeline
- First posted
- 2020-07-23
- Last updated
- 2024-03-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04483531. Inclusion in this directory is not an endorsement.