Effect of Insulin Resistance on the Safety and Efficacy of Pegylated Interferon and Ribavirin Treatment in HCV (Study P05562)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C, Chronic; Hepatitis C Virus

Treatments: Biological: Pegylated Interferon; Drug: Ribavirin

Study type: Observational

Funder types: Industry

Identifiers

NCT00705224

P05562

Details and patient eligibility

About

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.

Full description

consecutive patient sampling

Enrollment: 250 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 1 patient group

Patients with chronic hepatitis C

Description:

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.

Treatment:

Drug: Ribavirin

Biological: Pegylated Interferon