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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	June 23, 2008
Last Updated Date	May 6, 2009
Start Date ^†	May 2008
Current Primary Outcome Measures ^† (submitted: June 24, 2008)	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 ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00705224 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: June 24, 2008)	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 ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	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.
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
Study Phase
Study Type ^†	Observational
Study Design ^†	Cohort, Prospective
Condition ^†	Hepatitis C, Chronic Hepacivirus
Intervention ^†	Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908)
Study Arms / Comparison Groups	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.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	250
Estimated Completion Date	September 2010
Estimated Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility 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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	Russian Federation
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00705224
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Secondary IDs ^††
Study Sponsor ^†	Schering-Plough
Collaborators ^††
Investigators ^†
Information Provided By	Schering-Plough
Verification Date	May 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.