Effect of Insulin Resistance on the Safety and Efficacy of Pegylated Interferon and Ribavirin Treatment in HCV (Study P05562)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C, Chronic; Hepatitis C Virus
Intervention: Pegylated Interferon (Biological); Ribavirin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
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 design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study
Secondary outcome: Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at BaselinePercentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline
Detailed description:
consecutive patient sampling
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: May 2008
Last updated: June 4, 2015
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