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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
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Byler Disease

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All Sexes

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

    First Posted
    September 20, 2013
    Last Updated
    September 20, 2013
    Sponsor
    University of Pittsburgh
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    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

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