- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01949766
Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease
September 20, 2013 updated by: University of Pittsburgh
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.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Byler Disease
- Cholestasis
- Tolerance of Buphenyl therapy
Exclusion Criteria:
- Allergy/Hypersensitivity to RAVICTI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 20, 2013
First Submitted That Met QC Criteria
September 20, 2013
First Posted (ESTIMATE)
September 24, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 24, 2013
Last Update Submitted That Met QC Criteria
September 20, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO12070385.2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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