Buphenyl Therapy for Byler's Disease

Byler Disease Clinical Trial

Official title:

Compassionate Use of Buphenyl® in the Treatment of Byler's Disease

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01784718
• Other study ID #: PRO12070385
• Status: No longer available
• Phase: N/A
• First received: February 4, 2013
• Last updated: February 4, 2013

Study information

• Verified date: February 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 Buphenyl (4-phenylbutyrate) will improve the poor bile flow associated with Byler Disease.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Byler Disease

• Cholestasis unresponsive to pharmacologic therapy

Exclusion Criteria:

• Allergy/Hypersensitivity to Buphenyl

Study Design

N/A

Related Conditions & MeSH terms

• Byler Disease
• Cholestasis, Intrahepatic

Intervention

Drug:
• Buphenyl

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh