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Trial record 32 of 538 for:    IFNA2 AND RBV AND Hepatitis

A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

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ClinicalTrials.gov Identifier: NCT00623428
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : June 24, 2013
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: peginterferon alfa-2a
Drug: Ribavirin
Enrollment 235
Recruitment Details Patients with Chronic Hepatitis C, Genotype 2 or 3 who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care during a pre-study run-in phase and did not achieve a rapid viral response defined as HCV RNA <15 IU/mL at Week 4 of treatment were eligible and entered the screening phase between treatment Weeks 4-8.
Pre-assignment Details 235 patients enrolled and continued with the dose regimens they were taking prior to enrolment up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (compared to HCV RNA prior to treatment initiation) or had HCV RNA <15 IU/mL and who were still taking study medication at Week 24, were randomized at Week 24.
Arm/Group Title PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Hide Arm/Group Description After 24 weeks of treatment with pegylated-interferon (peginterferon) alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period. After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
Period Title: Treatment Period
Started 95 93
Completed 95 [1] 66 [2]
Not Completed 0 27
Reason Not Completed
Adverse event/intercurrent illness             0             9
Death             0             1
Did not cooperate / refused treatment             0             13
Insufficient therapeutic response             0             2
Other             0             1
Withdrawal by Subject             0             1
[1]
Patients who completed 24 weeks of treatment
[2]
Patients who completed 48 weeks of treatment
Period Title: Follow-up Period
Started 95 93
Completed 66 [1] 78 [2]
Not Completed 29 15
Reason Not Completed
Relapse post-treatment             11             3
Failure to return             10             2
Patient withdrew consent             5             4
HCV-RNA detectable at end of treatment             2             1
Did not cooperate             0             3
Reason not specified             1             1
Death             0             1
[1]
Patients who had an HCV RNA sample at 48 weeks of follow-up
[2]
Patients who had an HCV RNA sample at 24 weeks of follow-up
Arm/Group Title PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks Total
Hide Arm/Group Description After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period. After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period. Total of all reporting groups
Overall Number of Baseline Participants 95 93 188
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 93 participants 188 participants
48.8  (9.83) 48.6  (10.12) 48.7  (9.95)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 93 participants 188 participants
≤ 50 years 47 53 100
> 50 years 48 40 88
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 93 participants 188 participants
Female
40
  42.1%
39
  41.9%
79
  42.0%
Male
55
  57.9%
54
  58.1%
109
  58.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 93 participants 188 participants
Caucasian or white 82 81 163
Black 8 6 14
Asian or oriental 1 2 3
Other 4 4 8
Hepatitis C virus (HCV) genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 93 participants 188 participants
HCV Genotype 2 19 19 38
HCV Genotype 3 76 74 150
Pre-treatment HCV ribonucleic acid (RNA)  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 95 participants 93 participants 188 participants
6.11  (0.624) 6.17  (0.773) 6.14  (0.700)
Region   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 93 participants 188 participants
Non-U.S. 85 82 167
U.S. 10 11 21
[1]
Measure Description: Region (US and non-US) was used for stratification.
1.Primary Outcome
Title Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment
Hide Description

Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.

Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.

Time Frame 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients.
Arm/Group Title PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Hide Arm/Group Description:
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
Overall Number of Participants Analyzed 95 93
Measure Type: Number
Unit of Measure: percentage of participants
52 57
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a + Ribavirin for 24 Weeks, PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Comments In order to detect an improvement in SVR rate across all strata equivalent to an odds ratio of 2 (i.e. an increase in SVR by 15 to 16 percentage points at a power of 80% and a two-sided significance level of 0.05, 160 patients per treatment group (320 patients in total) were required.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4557
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.45 to 1.43
Estimation Comments

The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.

(second column).

2.Primary Outcome
Title Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment
Hide Description Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.
Time Frame 24 weeks after actual end of treatment (range from Week 48 to Week 72).
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients.
Arm/Group Title PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Hide Arm/Group Description:
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
Overall Number of Participants Analyzed 95 93
Measure Type: Number
Unit of Measure: percentage of participants
52 61
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a + Ribavirin for 24 Weeks, PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1934
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.38 to 1.21
Estimation Comments The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.
3.Secondary Outcome
Title Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation
Hide Description

Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.

Participants without Week 72 measurements were considered non-responders in the analysis.

Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients.
Arm/Group Title PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Hide Arm/Group Description:
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
Overall Number of Participants Analyzed 95 93
Measure Type: Number
Unit of Measure: percentage of participants
44 57
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a + Ribavirin for 24 Weeks, PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0788
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.33 to 1.06
Estimation Comments The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.
4.Secondary Outcome
Title Percentage of Participants With Virological Response at End of Treatment
Hide Description Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.
Time Frame End of Treatment (Week 24 and Week 48 for each treatment group respectively).
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients. A backward imputation approach was used when the HCV RNA measurement at end of treatment was missing and HCV RNA was <15 IU/mL at the first measurement after the end of treatment time window (the patient was regarded as having virological response at end of treatment).
Arm/Group Title PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Hide Arm/Group Description:
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
Overall Number of Participants Analyzed 95 93
Measure Type: Number
Unit of Measure: percentage of participants
93 90
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a + Ribavirin for 24 Weeks, PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5654
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.48 to 3.87
Estimation Comments The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.
5.Secondary Outcome
Title Percentage of Participants With Virological Relapse
Hide Description

Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.

Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.

Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end.

Time Frame End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized patients with virological response at the end of treatment and at least one post-treatment HCV RNA measurement.
Arm/Group Title PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Hide Arm/Group Description:
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
Overall Number of Participants Analyzed 83 80
Measure Type: Number
Unit of Measure: percentage of participants
41 29
6.Secondary Outcome
Title Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment
Hide Description Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.
Time Frame 12 weeks after actual end of treatment (range from Week 36 to Week 60)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients.
Arm/Group Title PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Hide Arm/Group Description:
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
Overall Number of Participants Analyzed 95 93
Measure Type: Number
Unit of Measure: percentage of participants
52 61
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a + Ribavirin for 24 Weeks, PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1934
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.38 to 1.21
Estimation Comments The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.
7.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as "incapacitating with inability to work or perform normal daily activity". A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above.
Time Frame From Week 1 through Week 72.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Hide Arm/Group Description:
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
Overall Number of Participants Analyzed 95 93
Measure Type: Number
Unit of Measure: participants
Any AE 81 88
Severe AE 13 24
AE related to PEG-IFN alfa-2a 78 86
AE related to ribavirin 72 83
Serious AE 4 11
SAE related to PEG-IFN alfa-2a 0 7
SAE related to ribavirin 0 4
Deaths 0 1
Time Frame 72 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Hide Arm/Group Description After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period. After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
All-Cause Mortality
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   4/95 (4.21%)   11/93 (11.83%) 
Blood and lymphatic system disorders     
Anaemia  1  1/95 (1.05%)  1/93 (1.08%) 
Thrombocytopenia  1  0/95 (0.00%)  1/93 (1.08%) 
Congenital, familial and genetic disorders     
Pyloric stenosis  1  1/95 (1.05%)  0/93 (0.00%) 
Gastrointestinal disorders     
Oesophageal varices haemorrhage  1  1/95 (1.05%)  0/93 (0.00%) 
Rectal haemorrhage  1  0/95 (0.00%)  1/93 (1.08%) 
Vomiting  1  0/95 (0.00%)  1/93 (1.08%) 
Infections and infestations     
Cellulitis  1  0/95 (0.00%)  1/93 (1.08%) 
Sepsis  1  0/95 (0.00%)  1/93 (1.08%) 
Injury, poisoning and procedural complications     
Road traffic accident  1  1/95 (1.05%)  0/93 (0.00%) 
Metabolism and nutrition disorders     
Hypertriglyceridaemia  1  0/95 (0.00%)  1/93 (1.08%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  0/95 (0.00%)  1/93 (1.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  1/95 (1.05%)  0/93 (0.00%) 
Diffuse large B-cell lymphoma  1  0/95 (0.00%)  1/93 (1.08%) 
Nervous system disorders     
Cerebrovascular accident  1  0/95 (0.00%)  1/93 (1.08%) 
Convulsion  1  0/95 (0.00%)  1/93 (1.08%) 
Psychiatric disorders     
Psychotic disorder  1  0/95 (0.00%)  1/93 (1.08%) 
Alcohol abuse  1  1/95 (1.05%)  0/93 (0.00%) 
Depression  1  0/95 (0.00%)  1/93 (1.08%) 
Renal and urinary disorders     
Mesangioproliferative glomerulonephritis  1  0/95 (0.00%)  1/93 (1.08%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/95 (0.00%)  1/93 (1.08%) 
Skin and subcutaneous tissue disorders     
Skin reaction  1  0/95 (0.00%)  1/93 (1.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   81/95 (85.26%)   87/93 (93.55%) 
Blood and lymphatic system disorders     
Anaemia  1  8/95 (8.42%)  9/93 (9.68%) 
Neutropenia  1  7/95 (7.37%)  7/93 (7.53%) 
Gastrointestinal disorders     
Nausea  1  13/95 (13.68%)  24/93 (25.81%) 
Diarrhoea  1  7/95 (7.37%)  14/93 (15.05%) 
Abdominal pain upper  1  7/95 (7.37%)  8/93 (8.60%) 
Dyspepsia  1  2/95 (2.11%)  10/93 (10.75%) 
Abdominal pain  1  3/95 (3.16%)  5/93 (5.38%) 
Vomiting  1  3/95 (3.16%)  5/93 (5.38%) 
Dry mouth  1  2/95 (2.11%)  5/93 (5.38%) 
General disorders     
Fatigue  1  33/95 (34.74%)  47/93 (50.54%) 
Asthenia  1  18/95 (18.95%)  14/93 (15.05%) 
Pyrexia  1  11/95 (11.58%)  11/93 (11.83%) 
Influenza like illness  1  14/95 (14.74%)  7/93 (7.53%) 
Irritability  1  12/95 (12.63%)  4/93 (4.30%) 
Chills  1  1/95 (1.05%)  5/93 (5.38%) 
Investigations     
Weight decreased  1  7/95 (7.37%)  9/93 (9.68%) 
Metabolism and nutrition disorders     
Decreased appetite  1  8/95 (8.42%)  15/93 (16.13%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  8/95 (8.42%)  18/93 (19.35%) 
Arthralgia  1  10/95 (10.53%)  13/93 (13.98%) 
Pain in extremity  1  7/95 (7.37%)  6/93 (6.45%) 
Back pain  1  9/95 (9.47%)  3/93 (3.23%) 
Nervous system disorders     
Headache  1  17/95 (17.89%)  30/93 (32.26%) 
Dizziness  1  6/95 (6.32%)  9/93 (9.68%) 
Psychiatric disorders     
Insomnia  1  21/95 (22.11%)  21/93 (22.58%) 
Depression  1  13/95 (13.68%)  11/93 (11.83%) 
Sleep disorder  1  6/95 (6.32%)  6/93 (6.45%) 
Anxiety  1  5/95 (5.26%)  4/93 (4.30%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/95 (7.37%)  12/93 (12.90%) 
Dyspnoea  1  9/95 (9.47%)  9/93 (9.68%) 
Dyspnoea exertional  1  8/95 (8.42%)  5/93 (5.38%) 
Epistaxis  1  5/95 (5.26%)  5/93 (5.38%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  17/95 (17.89%)  20/93 (21.51%) 
Alopecia  1  15/95 (15.79%)  17/93 (18.28%) 
Dry skin  1  13/95 (13.68%)  14/93 (15.05%) 
Rash  1  8/95 (8.42%)  9/93 (9.68%) 
Vascular disorders     
Hypertension  1  2/95 (2.11%)  8/93 (8.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00623428     History of Changes
Other Study ID Numbers: MV21371
2007-004993-15
First Submitted: February 18, 2008
First Posted: February 26, 2008
Results First Submitted: May 2, 2013
Results First Posted: June 24, 2013
Last Update Posted: July 22, 2013