Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease

Byler Disease Clinical Trial

Official title:

Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01949766
• Other study ID #: PRO12070385.2
• Status: No longer available
• Phase: N/A
• First received: September 20, 2013
• Last updated: September 20, 2013

Study information

• Verified date: September 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Both
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• Byler Disease

• Cholestasis

• Tolerance of Buphenyl therapy

Exclusion Criteria:

• Allergy/Hypersensitivity to RAVICTI

Study Design

N/A

Related Conditions & MeSH terms

• Byler Disease
• Cholestasis, Intrahepatic

Intervention

Drug:
• Glycerol phenylbutyrate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh