Back to resultsEfficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
Primary Purpose
Biliary Atresia
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Odevixibat
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Atresia focused on measuring Kasai
Eligibility Criteria
Inclusion Criteria:
- A male or female patient with a clinical diagnosis of BA
- Age at Kasai HPE ≤90 days
- Eligible to start study treatment within 3 weeks post-Kasai HPE
Key Exclusion Criteria:
- Patients with intractable ascites
- Ileal resection surgery
- ALT ≥10× upper limit of normal (ULN) at screening
- Patients reliant only on total parenteral nutrition, or not able to take study medication orally, at randomization
- Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
- Choledochal cystic disease
- INR >1.6 (the patient may be treated with Vitamin K intravenously; sample may be redrawn and if INR is ≤1.6 at resampling the patient may be randomized)
- Any other conditions or abnormalities, including congenital abnormalities, major cardiac surgery, hepatic, biliary, or GI disease which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the patient, the integrity of study results, or patient compliance with study requirements
- Weight <3.5kg at randomization
Sites / Locations
- Children's Hospital Los AngelesRecruiting
- Stanford Children's HealthRecruiting
- Rady Children's HospitalRecruiting
- UCSF Benioff Children's Hospital San FranciscoRecruiting
- Children's Hospital ColoradoRecruiting
- Nemours/Alfred I. duPont Hospital for ChildrenRecruiting
- Children's National Medical CenterRecruiting
- University of MiamiRecruiting
- Children's Healthcare of Atlanta - Emory University School of MedicineRecruiting
- Ann & Robert H. Lurie Children's HospitalRecruiting
- Indiana University school of MedicineRecruiting
- Johns Hopkins Children's CenterRecruiting
- Boston Children's HospitalRecruiting
- University of Michigan Children's HospitalRecruiting
- Children's Mercy HospitalRecruiting
- Washington University in St. LouisRecruiting
- The Children's Hospital at MontefioreRecruiting
- NYU Grossman school of MedicineRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- NewYork-Presbyterian Morgan Stanley Children's HospitalRecruiting
- Cincinnati Children's HospitalRecruiting
- Cleveland ClinicRecruiting
- Oregon Health & Science UniversityRecruiting
- The Children´s Hospital of PhiladelphiaRecruiting
- UPMC Children's Hospital of PittsburghRecruiting
- UT Southwestern Medical CenterRecruiting
- University of UtahRecruiting
- Seattle Children's HospitalRecruiting
- Medical College of WisconsinRecruiting
- Royal Children's HospitalRecruiting
- The Children´s Hospital at WestmeadRecruiting
- UZ GentRecruiting
- CHU Sainte-JustineRecruiting
- The Hospital for Sick ChildrenRecruiting
- Guangzhou Women and Children's Medical Center
- Children's Hospital of Fudan University
- Hôpital Femme Mère EnfantRecruiting
- Bicêtre HospitalRecruiting
- Jeanne de Flandre HospitalRecruiting
- Necker University Hospital - Enfants maladesRecruiting
- Charité - Universitätsmedizin BerlinRecruiting
- University Medical Center Hamburg-Eppendorf UKERecruiting
- Hannover Medical SchoolRecruiting
- University Children´s Hospital TuebingenRecruiting
- Semmelweis Egyetem I.sz Gyermekgyógyászati KlinikaRecruiting
- Schneider Children´s Medical Center of IsraelRecruiting
- ASST Papa Giovanni XXIIIRecruiting
- Meyer Children´s University HospitalRecruiting
- University Hospital of PadovaRecruiting
- ISMETT - Istituto Mediterraneo per i Trapianti e Terapie ad Alta SpecializzazioneRecruiting
- Ospedale Pediatrico Bambino GesùRecruiting
- Regina Margherita Children´s HospitalRecruiting
- Samsung Medical CenterRecruiting
- Seoul National University Children's HospitalRecruiting
- Hospital Raja Perempuan Zainab IIRecruiting
- University of Malaya Medical CentreRecruiting
- University Medical Center GroningenRecruiting
- Starship Child HealthRecruiting
- Instytut Pomnik-Centrum Zdrowia DzieckaRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- National Taiwan University HospitalRecruiting
- Hacettepe University Ihsan Dogramaci Childrens Hospital
- Akdeniz University Medical Faculty
- Istanbul University, Istanbul Medical Faculty
- Birmingham Women´s and Children´s HospitalRecruiting
- Leeds General InfirmaryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Odevixibat (A4250)
Placebo
Arm Description
Capsules for oral administration once daily for 104 weeks.
Capsules for oral administration (to match active) once daily for 104 weeks.
Outcomes
Primary Outcome Measures
Proportion of patients with liver transplant
Proportion of patients who are alive and have not undergone a liver transplant after 104 weeks of study treatment.
Secondary Outcome Measures
Time to onset of any sentinel events
Time to onset of any sentinel events
Time to pediatric end-stage liver disease (PELD) score >15
Time to pediatric end-stage liver disease (PELD) score >15
Total bilirubin levels
Total bilirubin level after 13, 26, 52, and 104 weeks of study treatment
Serum bile acid levels
Serum bile acid level after 13, 26, 52, and 104 weeks of study treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04336722
Brief Title
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
Official Title
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albireo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Up to 70 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Atresia
Keywords
Kasai
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
245 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Odevixibat (A4250)
Arm Type
Experimental
Arm Description
Capsules for oral administration once daily for 104 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules for oral administration (to match active) once daily for 104 weeks.
Intervention Type
Drug
Intervention Name(s)
Odevixibat
Intervention Description
Odevixibat is a small molecule and selective inhibitor of IBAT.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo identical in appearance to experimental drug (odevixibat).
Primary Outcome Measure Information:
Title
Proportion of patients with liver transplant
Description
Proportion of patients who are alive and have not undergone a liver transplant after 104 weeks of study treatment.
Time Frame
From baseline to Week 104
Secondary Outcome Measure Information:
Title
Time to onset of any sentinel events
Description
Time to onset of any sentinel events
Time Frame
From baseline to Week 104
Title
Time to pediatric end-stage liver disease (PELD) score >15
Description
Time to pediatric end-stage liver disease (PELD) score >15
Time Frame
From baseline to Week 104
Title
Total bilirubin levels
Description
Total bilirubin level after 13, 26, 52, and 104 weeks of study treatment
Time Frame
From baseline to Weeks 13, 26, 52 and 104
Title
Serum bile acid levels
Description
Serum bile acid level after 13, 26, 52, and 104 weeks of study treatment
Time Frame
From baseline to Weeks 13, 26, 52 and 104
10. Eligibility
Sex
All
Maximum Age & Unit of Time
111 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A male or female patient with a clinical diagnosis of BA
Age at Kasai HPE ≤90 days
Eligible to start study treatment within 3 weeks post-Kasai HPE
Key Exclusion Criteria:
Patients with intractable ascites
Ileal resection surgery
ALT ≥10× upper limit of normal (ULN) at screening
Patients reliant only on total parenteral nutrition, or not able to take study medication orally, at randomization
Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
Choledochal cystic disease
INR >1.6 (the patient may be treated with Vitamin K intravenously; sample may be redrawn and if INR is ≤1.6 at resampling the patient may be randomized)
Any other conditions or abnormalities, including congenital abnormalities, major cardiac surgery, hepatic, biliary, or GI disease which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the patient, the integrity of study results, or patient compliance with study requirements
Weight <3.5kg at randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albireo
Phone
+1 (857) 378-2035
Email
medinfo@albireopharma.com
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Kohli, MD
Facility Name
Stanford Children's Health
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amrita Narang, MD
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Schwarz, MD
Facility Name
UCSF Benioff Children's Hospital San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip Rosenthal, MD
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shikha Sundaram, MD
Facility Name
Nemours/Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adebowale Adeyemi, MD
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vahe Badalyan, MD
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Garcia, MD
Facility Name
Children's Healthcare of Atlanta - Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saul Karpen, MD, PhD
Facility Name
Ann & Robert H. Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Kriegermeier, MD
First Name & Middle Initial & Last Name & Degree
Alyssa Kriegermeier, MD
Facility Name
Indiana University school of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Molleston, MD
Facility Name
Johns Hopkins Children's Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wikrom Karnsakul, MD
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Wehrman, MD
Facility Name
University of Michigan Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maclovio Lopez, MD
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Fischer, MD
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janis M. Stoll, MD
Facility Name
The Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pan Debra, MD
First Name & Middle Initial & Last Name & Degree
Pan Debra, MD
Facility Name
NYU Grossman school of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia Ovchinsky, MD
First Name & Middle Initial & Last Name & Degree
Nadia Ovchinsky
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Chu, MD
Facility Name
NewYork-Presbyterian Morgan Stanley Children's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Goldner, MD
First Name & Middle Initial & Last Name & Degree
Dana Goldner, MD
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Rogers, MD
First Name & Middle Initial & Last Name & Degree
Michael Rogers, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vera Hupertz, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henry Lin, MD
Facility Name
The Children´s Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Loomes, MD
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Squires, MD
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amal Aqul, MD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyle Jensen, MD
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyn Hsu, MD
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cara Mack, MD
First Name & Middle Initial & Last Name & Degree
Cara Mack, MD
Facility Name
Royal Children's Hospital
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winita Hardikar, PhD
Facility Name
The Children´s Hospital at Westmead
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Stormon, MD
Facility Name
UZ Gent
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth De Bruyne, MD, PhD
Facility Name
CHU Sainte-Justine
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Alvarez, MD
Facility Name
The Hospital for Sick Children
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicky Ng, MD
Facility Name
Guangzhou Women and Children's Medical Center
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Children's Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Femme Mère Enfant
City
Bron
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathias Ruiz, MD
Facility Name
Bicêtre Hospital
City
Le Kremlin-Bicêtre
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Gonzales, MD, PhD
Facility Name
Jeanne de Flandre Hospital
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeleine Aumar, MD
Facility Name
Necker University Hospital - Enfants malades
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Lacaille, MD
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Bufler, MD
Facility Name
University Medical Center Hamburg-Eppendorf UKE
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konrad Reinshagen, MD
Facility Name
Hannover Medical School
City
Hanover
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Baumann, MD
Facility Name
University Children´s Hospital Tuebingen
City
Tuebingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekkehard Sturm, MD, PhD
Facility Name
Semmelweis Egyetem I.sz Gyermekgyógyászati Klinika
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antal Dezsöfi, MD, PhD
Facility Name
Schneider Children´s Medical Center of Israel
City
Petah tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orith Waisbourd-Zinman, MD
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo D'Antiga, MD
Facility Name
Meyer Children´s University Hospital
City
Florence
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Indolfi, MD, PhD
Facility Name
University Hospital of Padova
City
Padova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mara Cananzi, MD, PhD
Facility Name
ISMETT - Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Riva, MD
Facility Name
Ospedale Pediatrico Bambino Gesù
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Maggiore, MD
Facility Name
Regina Margherita Children´s Hospital
City
Turin
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pier Luigi Calvo, MD
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yon Ho Choe, MD
Facility Name
Seoul National University Children's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joong Kee Youn, MD
First Name & Middle Initial & Last Name & Degree
Joong Kee Youn, MD
Facility Name
Hospital Raja Perempuan Zainab II
City
Kota Bharu
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Mohd Ruzaimie Wan Mohamad Noor, MD
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Way Seah Lee, MD
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hendrik Jan Verkade, MD, PhD
Facility Name
Starship Child Health
City
Auckland
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Evans, MD
Facility Name
Instytut Pomnik-Centrum Zdrowia Dziecka
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Czubkowski, MD, PhD
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesús Quintero, MD, PhD
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huey-Ling Chen, PhD, MD
Facility Name
Hacettepe University Ihsan Dogramaci Childrens Hospital
City
Ankara
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Akdeniz University Medical Faculty
City
Antalya
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul University, Istanbul Medical Faculty
City
Istanbul
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Birmingham Women´s and Children´s Hospital
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chayarani Kelgeri, MD
Facility Name
Leeds General Infirmary
City
Leeds
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naved Alizai
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
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