CClinicalTrials.gg
No longer availableNCT01949766Updated Sep 24, 2013

Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease

An expanded access record providing Glycerol phenylbutyrate in Byler Disease, sponsored by University of Pittsburgh. No longer available. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2013-09-24.

Sponsored by University of Pittsburgh · Expanded access

Study type
Expanded access
Ages
6 Months and older
Sex
All
01

Study 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.

02

Conditions studied

  • Byler Disease
03

In context

Cholestasis, Intrahepatic

44 studies on the registry are indexed under Cholestasis, Intrahepatic; 12 are open to participants now.

Browse Cholestasis, Intrahepatic studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All

Inclusion criteria

  • Byler Disease
  • Cholestasis
  • Tolerance of Buphenyl therapy

Exclusion criteria

Exclusion Criteria:

  • Allergy/Hypersensitivity to RAVICTI
05

Access details

Study type
Expanded access

Available treatment

  • DrugGlycerol phenylbutyrate

    Also known as: RAVICTI

06

Where to request access

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01949766
Lead sponsor
University of Pittsburgh
Responsible party
Sponsor
First posted
Sep 24, 2013
Last update
Sep 24, 2013
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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