Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)

Phase 3

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Biological: PEGASYS (peginterferon alfa-2a); Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: REBETOL (ribavirin; SCH 18908); Drug: COPEGUS (ribavirin)

• Registration Number: NCT00081770
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.

Detailed Description

PegIntron Dose will be administered once weekly subcutaneously on the same day of the week:

Screening 2 Weight 40-50 kg Volume to Inject (mL) 0.22; Screening 2 Weight 51-60 kg Volume to Inject (mL) 0.28; Screening 2 Weight 61-75 kg Volume to Inject (mL) 0.33; Screening 2 Weight 76-85 kg Volume to Inject (mL) 0.41; Screening 2 Weight 86-104 kg Volume to Inject (mL) 0.48; Screening 2 Weight 105-125 kg Volume to Inject (mL) 0.58 from two vials

REBETOL Dosage (for Use With PegIntron):

Screening 2 Weight 40-65 kg Daily Dose 800 mg; Screening 2 Weight \>65-85 kg Daily Dose 1000 mg; Screening 2 Weight \>85-105 kg Daily Dose 1200 mg; Screening 2 Weight \>105-125 kg Daily Dose 1400 mg

The PEGASYS dose of 1 mL (180 µg) will be administered once weekly subcutaneously on the same day of the week

COPEGUS Dosage (for Use With PEGASYS):

Screening 2 Weight \<75 kg Daily Dose 1000 mg; Screening 2 Weight \> or = 75 kg Daily Dose 1200mg

NOTE: Double Blind for PegIntron; Open Label for REBETOL, PEGASYS and COPEGUS

NOTE: REBETOL is the Schering-Plough brand name for ribavirin. COPEGUS is the Hoffman-La Roche brand name for ribavirin.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2004-04-20
• Study First Submitted QC: 2004-04-21
• Study First Posted: 2004-04-22
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2008-11-03
• Results First Submitted QC: 2009-09-24
• Results First Posted: 2009-10-30
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4469

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PegIntron 1.0 ug/kg/wk plus REBETOL	REBETOL (ribavirin; SCH 18908)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PEGASYS 180 ug/wk Plus COPEGUS	PEGASYS (peginterferon alfa-2a)	PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PegIntron 1.5 ug/kg/wk plus REBETOL	REBETOL (ribavirin; SCH 18908)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PegIntron 1.0 ug/kg/wk plus REBETOL	PegIntron (peginterferon alfa-2b; SCH 54031)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PegIntron 1.5 ug/kg/wk plus REBETOL	PegIntron (peginterferon alfa-2b; SCH 54031)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PEGASYS 180 ug/wk Plus COPEGUS	COPEGUS (ribavirin)	PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up

Primary Outcome Measures

Name	Time	Method
Sustained Virologic Response (SVR) Rate	Assessed at the end of a 24-week post-treatment follow-up	SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.

Secondary Outcome Measures

Name	Time	Method
Virologic Response Rate at Treatment Week 12	Assessed at Treatment Week 12	Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12
Mean Change From Baseline in the Log Viral Load at Treatment Week 2	Assessed at Baseline and Treatment Week 2	The difference between viral load levels in the blood at the start of the study and Treatment Week 2, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.
Mean Change From Baseline in the Log Viral Load at Treatment Week 4	Assessed at Baseline and Treatment Week 4	The difference between viral load levels in the blood at the start of the study and Treatment Week 4, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.