Schering-Plough starts new hepatitis C study in liver transplant patients

By Elaine Rigoli

Tampa, Fla., May 23 - Schering-Plough said Tuesday that it has started a large, multi-center clinical trial in the United States to evaluate the safety and efficacy of Peg-Intron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) combination therapy in liver transplant recipients with recurrent hepatitis C virus infection.

Known as the Protect study, the trial is targeted to enroll 125 hepatitis C virus patients at about 28 liver transplant centers nationwide.

Protect is single-arm, multi-center, open-label phase 4 study evaluating the efficacy and safety of Peg-Intron (1.5 mcg/kg once weekly) and Rebetol (400-1,200 mg daily) in patients after orthotopic liver transplantation with chronic hepatitis C recurrence, according to a news release.

All patients will be enrolled within the first 12 months of this 72-week study and will be treated with up to 48 weeks of Peg-Intron and Rebetol therapy, the release said.

Based in Kenilworth, N.J., Schering-Plough is a global science-based health care company.

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