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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 Baseline

Percentage 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

Page last updated: August 23, 2015

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