Trial Outcomes & Findings for Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for HCV Genotype 1-infected Patients (NCT NCT00495131)

NCT ID: NCT00495131

Last Updated: 2009-09-10

Results Overview

Undetectable HCV RNA 6 months off therapy

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 308 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2009-09-10

Participant Flow

Recruitment period: 2006 June to September Location: academic centers

No wash out period in the study; all were treatment-naive All the patients who were eligible in the study were assigned to either groups without exclusion.

Participant milestones

Measure	Peginterferon and Ribavirin (24 Weeks) Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 24 weeks	Peginterferon and Ribavirin (48 Weeks) Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 48 weeks
Overall Study STARTED	154	154
Overall Study COMPLETED	147	148
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Measure	Peginterferon and Ribavirin (24 Weeks) Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 24 weeks	Peginterferon and Ribavirin (48 Weeks) Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 48 weeks
Overall Study Adverse Event	6	2
Overall Study Lack of Efficacy	0	2
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for HCV Genotype 1-infected Patients

Baseline characteristics by cohort

Measure	Peginterferon and Ribavirin (24 Weeks) n=154 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 24 weeks	Peginterferon and Ribavirin (48 Weeks) n=154 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 48 weeks	Total n=308 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	122 Participants n=5 Participants	128 Participants n=7 Participants	250 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants	26 Participants n=7 Participants	58 Participants n=5 Participants
Age Continuous	54 years STANDARD_DEVIATION 10 • n=5 Participants	53 years STANDARD_DEVIATION 11 • n=7 Participants	53 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	67 Participants n=7 Participants	133 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	87 Participants n=7 Participants	175 Participants n=5 Participants
Region of Enrollment Taiwan	154 participants n=5 Participants	154 participants n=7 Participants	308 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Intention-to-treat (ITT) analysis by last observation carried forward

Undetectable HCV RNA 6 months off therapy

Outcome measures

Measure	Peginterferon and Ribavirin (24 Weeks) n=154 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 24 weeks	Peginterferon and Ribavirin (48 Weeks) n=154 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 48 weeks
Sustained Virologic Response	87 participants	117 participants

PRIMARY outcome

Timeframe: 18 months

Population: Patients with end of follow-up alanine aminotransferase (ALT) levels

Sustained biochemical response (SBR): alanine aminotransferase (ALT) normalization

Outcome measures

Measure	Peginterferon and Ribavirin (24 Weeks) n=147 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 24 weeks	Peginterferon and Ribavirin (48 Weeks) n=148 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 48 weeks
Sustained Biochemical Response	75 Participants	107 Participants

SECONDARY outcome

Timeframe: 18 months

Treatment-related withdrawal rate: patients who prematurely discontinued treatment due to treatment-related adverse events

Outcome measures

Measure	Peginterferon and Ribavirin (24 Weeks) n=154 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 24 weeks	Peginterferon and Ribavirin (48 Weeks) n=154 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 48 weeks
Treatment-related Withdrawal Rate	6 Participants	14 Participants

SECONDARY outcome

Timeframe: 18 months

Population: Data included for analysis only for patients with paired liver biopsies.

Histologic response: improvement of at least 2 grade of scores by Ishak liver histologic classification by end of follow up liver biopsy to baseline liver biopsy

Outcome measures

Measure	Peginterferon and Ribavirin (24 Weeks) n=120 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 24 weeks	Peginterferon and Ribavirin (48 Weeks) n=124 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 48 weeks
Histologic Response	71 Participants	97 Participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chen-Hua Liu, MD

National Taiwan University Hospital

Phone: 886223123456

Email: jacque_liu@mail2000.com.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place