Clinical trial NCT00705224: Effect of Insulin Resistance on the Safety and Efficacy of Pegylated Interferon and Ribavirin Treatment in HCV (Study P05562)
Official title: Observational Multicenter Study to Evaluate Influence of Insulin Resistance on the Safety and Efficacy (as Measured by Sustained Virological Response) of Treatment With Any Pegylated Interferon and Ribavirin (Standard of Care) in Different Populations of HCV Patients in Russia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepatitis C Virus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include naïve patients with chronic hepatitis C (CHC) of any genotype who will be treated with a standard treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice in Russia.

Brief 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.

Detailed description: consecutive patient sampling

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.

Primary outcomes:
measure: Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
Secondary outcomes:
measure: Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
measure: Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline
timeFrame: Week 24 or 48 after treatment start
measure: Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
measure: Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline
timeFrame: Week 12 after treatment start
Other outcomes:
Locations:
Study officials:
References: