Peginterferon Alfa-2a and Ribavirin for Genotype 2 Chronic Hepatitis C: Duration and Ribavirin Dose Stratified by RVR

PHASE4CompletedINTERVENTIONAL
Enrollment

880

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Chronic Hepatitis C
Interventions
DRUG

Peg-IFN + WB RBV for 16 weeks

"1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (\< 75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) from weeks 1-4~2. Rapid virologic response (RVR) at week 4 of therapy: achieved~3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (\< 75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) from weeks 5-16"

DRUG

Peg-IFN + LD RBV for 16 weeks

"1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (\< 75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) from weeks 1-6~2. Rapid virologic response (RVR) at week 4 of therapy: achieved~3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 6-16"

DRUG

Peg-IFN + WB RBV for 24 weeks

"1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (\< 75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) from weeks 1-4~2. Rapid virologic response (RVR) at week 4 of therapy: not achieved~3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-24"

DRUG

Peg-IFN + WB RBV for 48 weeks

"1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (\< 75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) from weeks 1-4~2. Rapid virologic response (RVR) at week 4 of therapy: not achieved~3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-48"

DRUG

Peg-IFN + LD RBV for 24 weeks

"1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 1-24~2. Rapid virologic response (RVR) at week 4 of therapy: both achieved and not achieved"

Trial Locations (9)

100

National Taiwan University Hospital, Taipei

Unknown

National Taiwan University Hospital, Yun-Lin Branch, Douliu

Kaohsiung Medical University, Kaohsiung City

Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung City

Paochien Hospital, Pingtung City

Taichung Veterans General Hospital, Taichung

Buddhist Xindian Tzu Chi General Hospital, Taipei

Far Eastern Memorial Hospital, Taipei

Ren-Ai Branch, Taipei Municipal Hospital, Taipei

All Listed Sponsors
collaborator

National Science and Technology Council, Taiwan

OTHER_GOV

collaborator

Department of Health, Executive Yuan, R.O.C. (Taiwan)

OTHER_GOV

lead

National Taiwan University Hospital

OTHER

NCT00532701 - Peginterferon Alfa-2a and Ribavirin for Genotype 2 Chronic Hepatitis C: Duration and Ribavirin Dose Stratified by RVR | Biotech Hunter | Biotech Hunter