Who is sponsoring NCT01641666?

NCT01641666 is sponsored by Merck Sharp & Dohme LLC.

What condition does NCT01641666 study?

NCT01641666 studies Chronic Hepatitis C.

What drugs are being tested in NCT01641666?

Interventions: Boceprevir, Peginterferon Alfa-2b 1.5 mcg/kg/week, Ribavirin.

What is the status of NCT01641666?

NCT01641666 is currently WITHDRAWN.

Last reviewed 2015-09-07 · How we verify

An Open-Label Study to Assess the Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Any Interferon Plus Ribavirin in Vietnam

NCT01641666 Phase 3 WITHDRAWN

This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	WITHDRAWN
Start date	2014-05
Completion	2016-09

Conditions

Chronic Hepatitis C

Interventions

Boceprevir
Peginterferon Alfa-2b 1.5 mcg/kg/week
Ribavirin

Primary outcomes

Percentage of Participants Achieving Sustained Virologic Response (SVR) — Follow-Up Week 24
Percentage of Participants Experiencing a Serious Adverse Event (SAE) During the Study Therapy Period — Treatment Week 1 to Treatment Week 24