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Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01949766
Expanded Access Status : No longer available
First Posted : September 24, 2013
Last Update Posted : September 24, 2013
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh

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.

Condition or disease Intervention/treatment
Byler Disease Drug: Glycerol phenylbutyrate

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Study Type : Expanded Access
Official Title: Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease



Intervention Details:
  • Drug: Glycerol phenylbutyrate
    Other Name: RAVICTI

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Byler Disease
  • Cholestasis
  • Tolerance of Buphenyl therapy

Exclusion Criteria:

  • Allergy/Hypersensitivity to RAVICTI

No Contacts or Locations Provided

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Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01949766    
Other Study ID Numbers: PRO12070385.2
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
4-phenylbutyric acid
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents