Phase 4
Completed N=57
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00087568 ↗
Enrolled (actual)
57
Serious AEs
3.5%
Results posted
Jun 2016
Primary outcomePrimary: Number of Pegasys and Ribavirin Therapy Completers — 3; 23; 2; 23 Participants
◆ Published Evidence
Established
42citations · ~2 / year
Efficacy and safety of peginterferon alfa-2a/ribavirin in methadone maintenance patients: randomized comparison of direct observed therapy and self-administration.
Summary
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals.
Linked Publications (2)
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Efficacy and safety of peginterferon alfa-2a/ribavirin in methadone maintenance patients: randomized comparison of direct observed therapy and self-administration.
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Peginterferon alfa-2a/ribavirin in hepatitis C virus patients nontolerant or nonresponsive to peginterferon alfa-2b/ribavirin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pegasys and Ribavirin Therapy Completers |
3; 23; 2; 23 | — |
| SECONDARY Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time |
1; 16; 4; 24; 1; 21 | — |
| SECONDARY Number of Participants With Normal Serum Alanine Transaminase Levels Over Time |
21; 21; 18; 19; 9; 19 | — |
| SECONDARY Number of Participants With Serious Adverse Events and Adverse Events |
1; 1; 29; 23 | — |
| SECONDARY Mean Score of Beck Depression Inventory Over Time |
10.93; 15.03; 9.52; 10.68; 8.63; 10.76 | — |
| SECONDARY Mean Score of Fatigue Severity Over Time |
4.66; 5.14; 4.27; 4.50; 4.09; 4.72 | — |
| SECONDARY Number of Participants With Individual Flu-like Symptom |
16; 19; 10; 14; 17; 21 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
5; 3; 5; 6; 6; 3 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs |
1; 0; 1; 0; 0; 1 | — |
| SECONDARY Mean Score for Overall Local Injection Site Reaction |
0.25; 0.48; 0.03; 0.08; 0.00; 0.17 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients at least 18 years of age
- CHC infection, genotype 1
- unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks of treatment
- use of 2 forms of contraception during the study in both men and women
Exclusion Criteria
- women who are pregnant or breast-feeding
- medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
- patients with decompensated cirrhosis
- patients receiving any systemic antiviral therapy or investigational drug, other than PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug
Data sourced from ClinicalTrials.gov (NCT00087568) 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.