Clinical trials: Biliary Atresia
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to…
- Trial name
- NCT06553768
- Testing
- Maralixibat
- Where
- 23 sites in United States, Brazil and 8 more
- Volunteers
- 90 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Biliary Atresia
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia
- Trial name
- BOLD-EXT (NCT05426733)
- Testing
- Odevixibat
- Where
- 30 sites in United States, Australia and 12 more
- Volunteers
- 180 people
- Sponsor
- Albireo, an Ipsen Company
Biliary Atresia
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.
- Trial name
- NCT04336722
- Testing
- Odevixibat
- Where
- 72 sites in United States, Australia and 17 more
- Volunteers
- 254 people
- Sponsor
- Albireo, an Ipsen Company
Biliary Atresia
Obeticholic Acid in Pediatric Subjects With Biliary Atresia
This is a Phase 2, multicenter, open-label, single dose and multi-dose, dose-finding study with an optional open-label extension (OLE) to assess the safety, tolerability, and pharmacokinetics of obeticholic acid (OCA) in…
- Trial name
- CARE (NCT05321524)
- Testing
- OCA 0.1mg, OCA 1.5mg, OCA 5mg
- Where
- 17 sites in Belgium, France and 7 more
- Volunteers
- 7 people
- Sponsor
- Intercept Pharmaceuticals
Biliary Atresia
Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy
This study will evaluate the efficacy, safety and tolerability, as well as PK/PD of OCA in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterostomy).
- Trial name
- NCT06121375
- Testing
- OCA
- Where
- 24 sites in Australia, Canada and 8 more
- Volunteers
- 28 people
- Sponsor
- Intercept Pharmaceuticals
Biliary Atresia
Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai
A study to evaluate the efficacy and safety of maralixibat in infants with Biliary Atresia (BA) after Hepatoportoenterostomy (HPE, also known as the Kasai procedure).
- Trial name
- EMBARK (NCT04524390)
- Testing
- Maralixibat
- Where
- 22 sites in United States, China and 6 more
- Volunteers
- 75 people
- Sponsor
- Mirum Pharmaceuticals, Inc.