Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2010

Conditions
Hepatitis C, Chronic
Interventions
DRUG

Pegylated Interferon (PEG-IFN) alfa-2a

Pegylated interferon (PEG-IFN) alfa-2a (40 kilodalton \[KD\]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

DRUG

Placebo

Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

DRUG

Ribavirin

Ribavirin, 1000 mg orally (PO) (400 mg in the morning \[=2 tablets\] and 600 mg in the evening \[=3 tablets\]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Trial Locations (5)

13353

Berlin

30625

Hanover

60590

Frankfurt am Main

60594

Frankfurt am Main

66424

Homburg/ Saar

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY

NCT02716779 - Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection | Biotech Hunter | Biotech Hunter