Who is sponsoring NCT00107653?

NCT00107653 is sponsored by Hoffmann-La Roche.

What condition does NCT00107653 study?

NCT00107653 studies Hepatitis C, Chronic.

What drugs are being tested in NCT00107653?

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

What is the status of NCT00107653?

NCT00107653 is currently COMPLETED.

Last reviewed 2016-05-13 · How we verify

A Prospective, Multicenter, Open-label, Comparative, Efficacy Study of Pegasys® Plus Copegus® in Treatment-naïve Latino Patients With Chronic Hepatitis C-genotype 1, as Compared to Treatment-naïve Non- Latino Caucasian Patients With Chronic Hepatitis C-genotype 1

NCT00107653 Phase 4 COMPLETED Results posted

This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.

Details

Lead sponsor	Hoffmann-La Roche
Phase	Phase 4
Status	COMPLETED
Enrolment	569
Start date	2004-10
Completion	2007-09

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin
Peginterferon alfa-2a
Ribavirin
Peginterferon alfa-2a

Primary outcomes

Percentage of Participants With Sustained Virologic Response at Week 72 — At Week 72
Sustained Virologic Response (SVR) is defined as percentage of participants with an undetectable hepatitis C virus-RNA (HCV-RNA) measurement (\<28 International Unit (IU)/millilitre (mL)) assessed 24 weeks post-treatment (week 72) which was assessed by Roche High Pure System/COBAS TaqMan HCV Test.

Countries

United States, Puerto Rico