Phase 4
Completed N=569
Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00107653 ↗
Enrolled (actual)
569
Serious AEs
15.9%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response at Week 72 — 33.5; 49.3 Percentage of participants — p=<0.0001
◆ Published Evidence
Highly cited
182citations · ~11 / year
Peginterferon alfa-2a and ribavirin in Latino and non-Latino whites with hepatitis C.
Summary
This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.
Linked Publications
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Peginterferon alfa-2a and ribavirin in Latino and non-Latino whites with hepatitis C.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response at Week 72 |
33.5; 49.3 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Virologic Response |
13.8; 20.0; 48.0; 63.0; 59.5; 73.3 | 0.0454 sig |
| SECONDARY Percentage of Participants With Early Virologic Response at Week 4 |
71.0; 78.7 | 0.0353 sig |
| SECONDARY Percentage of Participants With Early Virologic Response at Week 12 |
75.5; 86.0 | 0.0014 sig |
| SECONDARY Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time |
-2.3; -2.9; -3.9; -4.5; -4.2; -4.8 | — |
| SECONDARY Percentage of Participants With Biochemical Response |
42.8; 57.0; 56.1; 72.0; 53.2; 68.0 | 0.0006 sig |
| SECONDARY Percentage of Participants With ISHAK Histological Activity Index Response |
47.1; 58.7 | 0.0285 sig |
| SECONDARY Mean Change From Baseline in ISHAK HAI Activity (Necroinflammatory) at Week 72 |
-1.4; -2.1 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72 |
-1.05; -2.64; -1.49; -2.04 | — |
| SECONDARY Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score |
24.8; 42.3; 52.9; 39.8; 22.3; 17.9 | — |
| SECONDARY Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72 |
-0.34; -0.51; 0.04; -0.12 | — |
| SECONDARY Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score |
54.1; 48.8; 7.0; 3.0; 38.9; 48.3 | — |
| SECONDARY Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score |
71.3; 66.2; 15.3; 11.4; 13.4; 22.4 | — |
| SECONDARY Mean Change From Baseline in Fat Score at Week 72 |
-0.15; -0.25 | — |
| SECONDARY Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72 |
47.8; 51.2; 20.4; 16.4; 31.8; 32.3 | — |
| SECONDARY Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score |
19.1; 18.4; 3.2; 2.0; 19.7; 9.5 | — |
| SECONDARY Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72 |
0.9; 1.5; -0.1; 0.1; 14.8; 25.4 | <0.0001 sig |
| SECONDARY Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72 |
-4.3; -8.4; -1.4; -1.8; -6.1; -6.3 | <0.0001 sig |
| SECONDARY Number of Participants With Any Adverse Events and Serious Adverse Events |
264; 292; 42; 48 | — |
| SECONDARY Number of Participants With Marked Abnormal Laboratory Parameters |
49; 67; 99; 126; 78; 103 | — |
| SECONDARY Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities |
8; 12; 4; 5; 3; 6 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients 18-65 years of age
- chronic hepatitis C , genotype 1
- serologic evidence of CHC infection by an antibody test
- chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months
- compensated liver disease
- use of 2 forms of contraception during the study in both men and women
Exclusion Criteria
- previous interferon or ribavirin therapy
- systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study
- medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
- decompensated liver disease
- women who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00107653) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.