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Trial record 5 of 5 for:    "benign recurrent intrahepatic cholestasis" OR "cholestatic pruritus"

A4250, an IBAT Inhibitor in Pediatric Cholestasis

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ClinicalTrials.gov Identifier: NCT02630875
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Albireo

Brief Summary:
This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus

Condition or disease Intervention/treatment Phase
Pediatric Cholestasis Drug: A4250 Phase 2

Detailed Description:

The primary aims of this Phase II exploratory study in patients treated with A4250 due to cholestasis induced pruritus are to:

  • Assess the safety and tolerability of A4250, orally administered first as a single dose and then during a four week treatment period, as determined by the occurrence of treatment-emergent SAEs
  • Explore changes in serum total bile acids after a four week treatment period

Secondary safety aims include assessment of the safety and tolerability of A4250, orally administered first as a single dose and then during a four week treatment period, as determined by the occurrence of treatment-emergent AEs and changes in safety parameters including laboratory tests and vital signs

Secondary efficacy aims are to:

  • Demonstrate the efficacy of A4250, orally administered during a four week treatment period, on liver biochemistry variables and on pruritus parameters
  • Evaluate the pharmacokinetic properties of A4250 orally administered first as a single dose and then after a four week treatment period
  • Evaluate changes in VAS-itching score after a four week treatment period

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Phase II Study to Demonstrate the Safety and Efficacy of A4250 in Children With Cholestatic Pruritus
Study Start Date : August 2015
Actual Primary Completion Date : March 17, 2017
Actual Study Completion Date : March 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Active Comparator: A4250 1
Dose I
Drug: A4250
A4250

Active Comparator: A4250 2
Dose 2
Drug: A4250
A4250

Active Comparator: A4250 3
Dose 3
Drug: A4250
A4250

Active Comparator: A4250 4
Dose 4
Drug: A4250
A4250

Active Comparator: A4250 5
Dose 5
Drug: A4250
A4250

Active Comparator: A4250 6
Dose 6
Drug: A4250
A4250




Primary Outcome Measures :
  1. AE evaluation [ Time Frame: 4 wks ]
    Treatment-emergent SAEs Adverse events


Secondary Outcome Measures :
  1. Bile acid changes [ Time Frame: 4 weeks ]
    Evaluation of bile acids



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of pruritus due to chronic cholestasis based on history and investigator judgment. This will include but will not be restricted to patients with Progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS), Biliary Atresia and Sclerosing Cholangitis

Exclusion Criteria:

  • Any condition that in the opinion of the investigator constitutes a risk for the patient or a contraindication for participation and completion of the study, or could interfere with study objectives, conduct, or evaluations
  • Clinical or biochemical signs of decompensated liver disease
  • Liver transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630875


Locations
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Denmark
Department of Pediatric and Adolescent Medicine Rigshospitalet
Copenhagen, Denmark
France
Pediatric Hepatology and Liver Transplantation, University Hospitals of Paris-Sud
Paris, Orsay, France
Department of Pediatric Gastroenterology Hepatology-Nutrition, Necker-Enfants maladies hospital
Paris, France
Germany
Pediatric Gastroenterology and Hepatology, Pediatric Surgery, Hannover
Hannover, Germany
Gastroenterology/Hepatology, University Hospital for Children and Adolescents
Tuebingen, Germany
Sweden
Henrik Arnell
Stockholm, Sweden, 17176
United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Albireo
Investigators
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Study Chair: Mats Ekelund, MD Albireo
Principal Investigator: Henrik Arnell, MD Karolinska

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Responsible Party: Albireo
ClinicalTrials.gov Identifier: NCT02630875     History of Changes
Other Study ID Numbers: A4250-003
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases