Who is sponsoring NCT00845065?

NCT00845065 is sponsored by Merck Sharp & Dohme LLC.

What condition does NCT00845065 study?

NCT00845065 studies Hepatitis C, Chronic.

What drugs are being tested in NCT00845065?

Interventions: Boceprevir, Placebo, Peginterferon alfa-2a, Ribavirin.

What is the status of NCT00845065?

NCT00845065 is currently COMPLETED.

Last reviewed 2017-03-09 · How we verify

A Phase 3 Safety and Efficacy Study of Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin

NCT00845065 Phase 3 COMPLETED Results posted

Based on previous experience with peginterferon alfa-2b/ribavirin in combination with boceprevir, the combination with peginterferon alfa- 2a/ribavirin and boceprevir is expected to be safe and well tolerated. Given the wide utilization of both peginterferons and the clear benefit of the addition of boceprevir to peginterferon alfa-2b/ribavirin, it is important to demonstrate the safety and efficacy of boceprevir in combination with peginterferon alfa-2a/ribavirin.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	COMPLETED
Enrolment	202
Start date	2009-02
Completion	2010-10

Conditions

Hepatitis C, Chronic

Interventions

Boceprevir
Placebo
Peginterferon alfa-2a
Ribavirin

Primary outcomes

Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population. — Follow-up Week 24
SVR rate was the percentage of participants treated with at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo) who had achieved SVR. SVR was defined as undetectable Hepatitis C Virus-Ribonucleic Acid (HCV RNA).