NCT01784718|Unknown
Buphenyl Therapy for Byler's Disease
Compassionate Use of Buphenyl® in the Treatment of Byler's Disease
1 other identifier
PRO12070385
Study Type
expanded_access
Target
N/A
Locations
0 countries
Sites
N/A
Timeline
RegisteredFeb 2013
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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2013
Completed2 days until next milestone
First Posted
Study publicly available on registry
February 6, 2013
CompletedLast Updated
February 6, 2013
Status Verified
February 1, 2013
First QC Date
February 4, 2013
Last Update Submit
February 4, 2013
Conditions
Interventions
BuphenylDRUG
Eligibility Criteria
Age1 Year+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
You may qualify if:
- Byler Disease
- Cholestasis unresponsive to pharmacologic therapy
You may not qualify if:
- Allergy/Hypersensitivity to Buphenyl
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Cholestasis, progressive familial intrahepatic 1
Interventions
4-phenylbutyric acid
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2013
First Posted
February 6, 2013
Last Updated
February 6, 2013
Record last verified: 2013-02