N/A
Completed N=250
Effect of Insulin Resistance on the Safety and Efficacy of Pegylated Interferon and Ribavirin Treatment in HCV (Study P05562)
Hepatitis C, Chronic · Hepatitis C
Source: ClinicalTrials.gov NCT00705224 ↗
Enrolled (actual)
250
Serious AEs
0.8%
Results posted
Sep 2011
Primary outcomePrimary: Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study — 81.2 Percentage of Participants
Summary
Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice in Russia. The objective of this study is to examine the influence of insulin resistance on the safety and efficacy of treatment with pegylated interferon and ribavirin and to determine the prevalence of insulin resistance in different populations of CHC patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study |
81.2 | — |
| SECONDARY Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline |
45.7; 47.5; 14.3; 7.5; 38.6; 45.0 | — |
| SECONDARY Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline |
50.6; 52.9; 12.2; 5.9; 35.9; 41.2 | — |
| SECONDARY Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline |
83.3; 72.7; 0; 0; 16.7; 27.3 | — |
| SECONDARY Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline |
51.3; 54.0; 12.7; 6.0; 34.8; 40.0 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of CHC according to local regulations
- Naïve Pegylated Interferon (PEG-IFN) CHC patient
- No contraindications for PEG-IFN CHC therapy
- Negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end
- Willingness to give written informed consent and willingness to participate in and comply with the study requirements.
Exclusion Criteria
- PEG-IFN treatment in history
- Contraindications for PEG-IFN CHC therapy
- Females who are pregnant or breast-feeding
- Male partners of females who are pregnant
- Potentially unreliable participants, and those judged by the investigator to be unsuitable for the study.
Data sourced from ClinicalTrials.gov (NCT00705224). 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.