Brief Summary

This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (\>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram \[mg\]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up. Participants with detectable HCV-RNA and less than (\<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

236

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jun 2007

Typical duration for phase_3

Geographic Reach

2 countries

23 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

June 1, 2007

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2007

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed

6.7 years until next milestone

Results Posted

Study results publicly available

January 23, 2017

Completed

Last Updated

January 23, 2017

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

June 7, 2007

Results QC Date

November 25, 2016

Last Update Submit

November 25, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)
SVR was defined as success if the participant had HCV RNA levels \<15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.
At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)

Secondary Outcomes (2)

Percentage of Participants With SVR (Groups C, D, E, and F)
At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)
Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)
Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)

Study Arms (7)

Pegylated-interferon Alfa-2a + Ribavirin (Group A)

EXPERIMENTAL

Participants with HCV RNA levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, will receive pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 milligrams (mg) orally daily for 48 weeks.