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

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00705224

Purpose

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.

Condition	Intervention
Hepatitis C, Chronic Hepacivirus	Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908)

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Insulin Ribavirin Peginterferon Alfa-2b Interferons

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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.

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Rates of adverse events and serious adverse events and the effect of insulin resistance during treatment with any pegylated interferon and ribavirin in different populations of patients and in the overall population of patients with chronic hepatitis C. [ Time Frame: Information on adverse events will be collected at Day 0 and at Weeks 4 and/or 12, 24, 48, and 72. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Rates of sustained virological response (SVR), defined as undetectable HCV RNA in serum at 24 weeks after completion of therapy with any pegylated interferon and ribavirin, in different populations of patients with chronic hepatitis C. [ Time Frame: Serum HCV RNA will be measured at Day 0, Week 4 and/or 12, and at Week 48 (for 24-week treatment duration) or Week 72 (for 48-week treatment duration). ] [ Designated as safety issue: No ]
Prevalence of insulin resistance in different populations of patients with chronic hepatitis C. [ Time Frame: Prevalence of insulin resistance will be assessed at Day 0. Insulin resistance will be calculated based on glucose and insulin fasting levels. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	250
Study Start Date:	May 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with chronic hepatitis C 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.	Biological: Peginterferon alfa-2b (SCH 54031) Routine treatment with a combination of any pegylated interferon and ribavirin will be used according to the label/local practice in Russia. The treatment course duration will comply with the labeled dosage regimen. The Sponsor will not provide formal drug supply. Drug: Ribavirin (SCH 18908) Routine treatment with a combination of any pegylated interferon and ribavirin will be used according to the label/local practice in Russia. The treatment course duration will comply with the labeled dosage regimen. The Sponsor will not provide formal drug supply.

Groups/Cohorts

Assigned Interventions

Patients with chronic hepatitis C

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.

Biological: Peginterferon alfa-2b (SCH 54031)

Routine treatment with a combination of any pegylated interferon and ribavirin will be used according to the label/local practice in Russia.

The treatment course duration will comply with the labeled dosage regimen. The Sponsor will not provide formal drug supply.

Drug: Ribavirin (SCH 18908)

Routine treatment with a combination of any pegylated interferon and ribavirin will be used according to the label/local practice in Russia.

The treatment course duration will comply with the labeled dosage regimen. The Sponsor will not provide formal drug supply.

Detailed Description:

consecutive patient sampling

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

Inclusion Criteria:

Confirmed diagnosis of CHC according local regulations
Naïve 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 patients, and those judged by the investigator to be unsuitable for the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705224

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Russian Federation
Coordinating Location	Recruiting
Moscow, Russian Federation

Sponsors and Collaborators

Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05562
Study First Received:	June 23, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00705224
Health Authority:	Russia: Ethics Committee

Study placed in the following topic categories:

Liver Diseases
Metabolic Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Insulin
Hepatitis
Virus Diseases

Hyperinsulinism
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Insulin Resistance
Glucose Metabolism Disorders
Metabolic disorder
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections

Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009