NCT00461799

Brief Summary

The purpose of this study was to determine whether orlistat is effective in decreasing plasma unconjugated bilirubin levels in patients with Crigler-Najjar disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2003

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
Last Updated

April 18, 2007

Status Verified

April 1, 2007

First QC Date

April 16, 2007

Last Update Submit

April 16, 2007

Conditions

Crigler-Najjar Syndrome

Keywords

Crigler-Najjar disease.Bilirubin.Phototherapy.Orlistat.Unconjugated hyperbilirubinemia.

Outcome Measures

Primary Outcomes (3)

  • decrease in plasma unconjugated bilirubin level during orlistat

  • increase in fecal fat excretion during orlistat

  • increase in fecal bilirubin concentration during orlistat

Interventions

orlistatDRUG

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with Crigler-Najjar disease above the age of 7 years

You may not qualify if:

  • cholestasis, chronic malabsorption syndrome, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus University Medical Center

Rotterdam, 3015 GJ, Netherlands

Location

Related Publications (4)

  • Hafkamp AM, Havinga R, Sinaasappel M, Verkade HJ. Effective oral treatment of unconjugated hyperbilirubinemia in Gunn rats. Hepatology. 2005 Mar;41(3):526-34. doi: 10.1002/hep.20589.

    PMID: 15726662BACKGROUND

  • Hafkamp AM, Havinga R, Ostrow JD, Tiribelli C, Pascolo L, Sinaasappel M, Verkade HJ. Novel kinetic insights into treatment of unconjugated hyperbilirubinemia: phototherapy and orlistat treatment in Gunn rats. Pediatr Res. 2006 Apr;59(4 Pt 1):506-12. doi: 10.1203/01.pdr.0000203180.79636.98.

    PMID: 16549520BACKGROUND

  • Nishioka T, Hafkamp AM, Havinga R, vn Lierop PP, Velvis H, Verkade HJ. Orlistat treatment increases fecal bilirubin excretion and decreases plasma bilirubin concentrations in hyperbilirubinemic Gunn rats. J Pediatr. 2003 Sep;143(3):327-34. doi: 10.1067/s0022-3476(03)00298-1.

    PMID: 14517515BACKGROUND

  • Verkade HJ. A novel hypothesis on the pathophysiology of neonatal jaundice. J Pediatr. 2002 Oct;141(4):594-5. No abstract available.

    PMID: 12378205BACKGROUND

MeSH Terms

Conditions

Crigler-Najjar Syndrome

Interventions

Orlistat

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, HereditaryMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Study Officials

  • Anja M. Hafkamp, MD

    University Medical Center Groningen and Erasmus University Medical Center

    PRINCIPAL INVESTIGATOR

  • Maarten Sinaasappel, MD

    Erasmus Medical Center

    STUDY CHAIR

  • Henkjan J. Verkade, MD, PhD

    University Medical Center Groningen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 18, 2007

Study Start

September 1, 2003

Study Completion

January 1, 2004

Last Updated

April 18, 2007

Record last verified: 2007-04

Locations

NL(1)