Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease
Primary Purpose
Byler Disease
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Glycerol phenylbutyrate
Sponsored by
About this trial
This is an expanded access trial for Byler Disease
Eligibility Criteria
Inclusion Criteria:
- Byler Disease
- Cholestasis
- Tolerance of Buphenyl therapy
Exclusion Criteria:
- Allergy/Hypersensitivity to RAVICTI
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01949766
First Posted
September 20, 2013
Last Updated
September 20, 2013
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT01949766
Brief Title
Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease
Official Title
Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 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 RAVICTI will improve bile flow in a subject who previously tolerated therapy with Buphenyl.
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)
Glycerol phenylbutyrate
Other Intervention Name(s)
RAVICTI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Eligibility Criteria
Inclusion Criteria:
Byler Disease
Cholestasis
Tolerance of Buphenyl therapy
Exclusion Criteria:
Allergy/Hypersensitivity to RAVICTI
12. IPD Sharing Statement
Learn more about this trial
Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease
We'll reach out to this number within 24 hrs