Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease

University of Pittsburgh

Status

Conditions: Byler Disease

Treatments: Drug: Glycerol phenylbutyrate

Study type: Expanded Access

Funder types: Other

Identifiers

NCT01949766

PRO12070385.2

Details and patient eligibility

About

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.

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Byler Disease
• Cholestasis
• Tolerance of Buphenyl therapy

Exclusion criteria

• Allergy/Hypersensitivity to RAVICTI