Last reviewed · How we verify
NCT04530994
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)
trial testing maralixibat in Alagille Syndrome. Approved for marketing.
Quick facts
| Lead sponsor | Mirum Pharmaceuticals, Inc. |
|---|---|
| Status | APPROVED FOR MARKETING |
| Study type | EXPANDED_ACCESS |
| Sites | 14 locations across United States |
Drugs / interventions tested
- maralixibat — full drug profile →
Conditions studied
- Alagille Syndrome — all drugs for Alagille Syndrome →
Sponsor
Mirum Pharmaceuticals, Inc. — full company profile →
Who can join
12 Months and older, any sex, with Alagille Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An open-label, single-arm, multi-centre program providing treatment access to ALGS patients with cholestatic pruritus in the US. Access can be requested through Clinigen Healthcare Ltd via email MirumALGS@clinigengroup.com or telephone +1-877-768-4303.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04530994
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Alagille Syndrome
Currently open trials in the same condition.
- NCT07290257 — Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome i · Phase 4 · recruiting
- NCT06193928 — Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US) · recruiting
- NCT05035030 — Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome · Phase 3 · recruiting
Other Mirum Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT07454837 — Phase 2b/3 Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide · Phase 2, PHASE3 · recruiting
- NCT07290257 — Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome i · Phase 4 · recruiting
- NCT07200908 — A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) · Phase 3 · recruiting
- NCT06193928 — Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US) · recruiting
- NCT04729751 — A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases In · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04530994 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mirum Pharmaceuticals, Inc.
- Last refreshed: 20 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04530994.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing