NCT01949766|Unknown
Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease
1 other identifier
PRO12070385.2
Study Type
expanded_access
Target
N/A
Locations
0 countries
Sites
N/A
Timeline
RegisteredSep 2013
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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2013
Completed4 days until next milestone
First Posted
Study publicly available on registry
September 24, 2013
CompletedLast Updated
September 24, 2013
Status Verified
September 1, 2013
First QC Date
September 20, 2013
Last Update Submit
September 20, 2013
Conditions
Interventions
Also known as: RAVICTI
Eligibility Criteria
Age6 Months+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
You may qualify if:
- Byler Disease
- Cholestasis
- Tolerance of Buphenyl therapy
You may not qualify if:
- Allergy/Hypersensitivity to RAVICTI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Cholestasis, progressive familial intrahepatic 1
Interventions
glycerol phenylbutyrate
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2013
First Posted
September 24, 2013
Last Updated
September 24, 2013
Record last verified: 2013-09