Phase 4
Completed N=385
Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00087607 ↗
Enrolled (actual)
385
Serious AEs
8.0%
Results posted
Jul 2016
Primary outcomePrimary: Change From Baseline in Viral Load (log10 Reduction) at Week 12 — -3.26; -3.27 log (IU/mL) — p=0.978
Summary
This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Viral Load (log10 Reduction) at Week 12 |
-3.26; -3.27 | 0.978 |
| SECONDARY Mean Change From Baseline in Viral Load (log10 Reduction) at Week 4 and Week 8 |
-1.95; -2.22; -2.88; -2.95 | 0.080 |
| SECONDARY Weekly Viral Load Assessed at Drug Trough |
6.46; 6.48; 5.69; 5.70; 5.26; 5.12 | — |
| SECONDARY The Area Under the HCV-RNA Curve Estimated From the Two Adjacent Pre-dose Assessments at Each Week |
6.5; 6.5; 6.1; 6.1; 5.5; 5.4 | — |
| SECONDARY Mean Value of Area Under the HCV-RNA Curve Minus Baseline From Week 1 to Week 12 |
0.4; 0.4; 1.0; 1.1; 1.4; 1.6 | — |
| SECONDARY Cumulative Viral Absolute Area Under the HCV RNA Curve Minus Baseline Averaged Over the 12-week Period |
26.9; 28.7 | 0.304 |
| SECONDARY Weekly Viral Absolute Area Under the HCV RNA Curve Estimated in the Frequent-sampling Cohort for Weeks 1 and 8 |
6.0; 6.0; 3.4; 3.5; 5.8; 5.5 | — |
| SECONDARY Percentage of Participants With a ≥ 2-log10 Decrease or Undetectable (< 60 International Units Per Milliliter) HCV RNA at Each Visit |
6.9; 9.9; 20.1; 30.4; 31.7; 42.4 | 0.2814 |
| SECONDARY Percentage of Participants With Undetectable HCV RNA (< 60 International Units/Milliliter) at Each Visit |
0.5; 0.5; 1.6; 2.1; 2.6; 6.3 | 0.9940 |
| SECONDARY Number of Participants With Marked Hematologic Abnormalities |
64; 69; 41; 31; 72; 90 | — |
| SECONDARY Number of Participants With Marked Biochemical Test Abnormalities |
5; 12; 17; 11; 23; 18 | — |
| SECONDARY Number of Participants With Marked Abnormalities in Thyroid Function Tests |
4; 3; 4; 2; 1; 1 | — |
| SECONDARY Mean Trough Interferon Concentrations at Each Week |
6730; 119; 9530; 144; 11082; 125 | — |
| SECONDARY Area Under the Curve for Interferon in the Frequent-Sampling Cohort |
6376.0; 315.2; 14399.9; 472.1 | 0.024 sig |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events |
185; 187; 5; 2 | — |
| SECONDARY Percentage of Participants With Each of the Identified HCV Quasispecies at Baseline and Weeks 1, 4, 8, and 12 |
— | — |
| SECONDARY Weekly AUC for IFN Concentrations for Pegasys and PEG-Intron Estimated by Population Pharmacokinetic Modeling |
— | — |
Eligibility Criteria
Inclusion Criteria
- adult patients at least 18 years of age
- CHC infection, genotype 1
- use of 2 forms of contraception during study in both men and women
Exclusion Criteria
- previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory agents
- medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
- decompensated liver disease
- women who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00087607). 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.