NCT00207363

Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With CHC

Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With Chronic Hepatitis C

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 610 (actual)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see which of two doses of PEG (polyethylene glycol) interferon alfa-2b in combination with Ribavirin for 48 weeks is more effective at elimination of hepatitis C. The primary objective of this study is to compare the efficacy of Induction PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) in patients with chronic hepatitis C.

Detailed description

The purpose of this study is to determine if the use of induction dose PEG-Intron in combination with Rebetol will enhance the elimination of Hepatitis C in treatment naïve patients with genotype 1 and 4. Currently PEG-Interferon alfa-2b plus Ribavirin results in a sustained response in 54-61% of patients with Hepatitis C. Those with genotype 1and 4 and high viral loads are the most likely to have a less favorable response. The administration of induction dose interferon in combination with Ribavirin may yield an improved sustained response rate in these more difficult to treat patients with chronic Hepatitis C.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Ribavirin, Peg interferon alfa 2b	Peg interferon alfa 2b 1.5mcg/kg/wk for 48 weeks ribavirin 13+/-2 mg/kg daily for 48 weeks
DRUG	induction therapy	Peg Intron 3.0mcg/kg/wk for 12 weeks then Peg interon 1.5mcg/kg/week for 36 weeks

Timeline

• Start date: 2002-02-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2005-09-21
• Last updated: 2012-02-14

Locations

1 site across 1 country: United States