Back to resultsBuphenyl Therapy for Byler's Disease
Primary Purpose
Byler Disease
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Buphenyl
Sponsored by
About this trial
This is an expanded access trial for Byler Disease
Eligibility Criteria
Inclusion Criteria:
- Byler Disease
- Cholestasis unresponsive to pharmacologic therapy
Exclusion Criteria:
- Allergy/Hypersensitivity to Buphenyl
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01784718
First Posted
February 4, 2013
Last Updated
February 4, 2013
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT01784718
Brief Title
Buphenyl Therapy for Byler's Disease
Official Title
Compassionate Use of Buphenyl® in the Treatment of Byler's Disease
Study Type
Expanded Access
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
4. Oversight
5. Study Description
Brief Summary
This is a single patient compassionate use protocol to determine whether Buphenyl (4-phenylbutyrate) will improve the poor bile flow associated with Byler Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Byler Disease
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buphenyl
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Eligibility Criteria
Inclusion Criteria:
Byler Disease
Cholestasis unresponsive to pharmacologic therapy
Exclusion Criteria:
Allergy/Hypersensitivity to Buphenyl
12. IPD Sharing Statement
Learn more about this trial
Buphenyl Therapy for Byler's Disease
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