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Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

NCT04674761 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-11-02

Study results available
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Summary

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.

Conditions

  • Alagille Syndrome

Interventions

DRUG

Odevixibat

Odevixibat is a small molecule and selective inhibitor of IBAT.

DRUG

Placebo

Placebo identical in appearance to experimental drug (odevixibat).

Sponsors & Collaborators

  • Albireo

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-19
Primary Completion
2022-09-09
Completion
2022-09-09
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Malaysia
  • Netherlands
  • New Zealand
  • Poland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04674761 on ClinicalTrials.gov