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

June 4, 2015 updated by: Merck Sharp & Dohme LLC

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

consecutive patient sampling

Study Type

Observational

Enrollment (Actual)

250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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: Pegylated Interferon

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

The treatment course duration complied with the labeled dosage regimen. Each dose of pegylated interferon was administered as a subcutaneous

injection calculated as 1.5 mcg/kg once a week. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C.

The Sponsor did not provide formal drug supply.

Other Names:
  • PegIntron
  • (SCH 54031)
Drug: Ribavirin

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

The treatment course duration complied with the labeled dosage regimen. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the

morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.

The Sponsor did not provide formal drug supply.

Other Names:
  • Rebetol
  • (SCH 18908)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
Sustained Virological response (SVR) was assessed at the end of the study (Visit 4) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.
24 weeks following completion of 24 or 48 weeks of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
SVR was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as Homeostasis model assessment - of insulin-resistance [HOMA-IR] >3) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.
24 weeks following completion of 24 or 48 weeks of therapy
Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline
Time Frame: Week 24 or 48 after treatment start
Response following treatment (RFT) was assessed at the end of treatment (Visit 3) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the presence or absence of RFT. RFT was defined as undetectable plasma HCV-RNA at end of treatment. Visit 3 was considered Week 24 or Week 48 after treatment start depending on treatment duration.
Week 24 or 48 after treatment start
Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
Virological relapse (VR) was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who demonstrated VR. VR was defined as undetectable plasma HCV-RNA (RFT +) at end of treatment (Visit 3- considered Week 24 or Week 48 after treatment start depending on treatment duration), but lost RFT (considered sustained non-Responders) at end of study (Visit 4- considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively).
24 weeks following completion of 24 or 48 weeks of therapy
Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline
Time Frame: Week 12 after treatment start
Early Virological response (EVR) was assessed at 12 weeks after treatment start (Visit 2) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who achieved EVR. EVR was defined as a substantial (greater than 2 log10) decrease in viral load (measured as International Units/milliliter) and/or negative Polymerase chain reaction (PCR)-based viral load qualitative result as assessed at visit 2 of the study.
Week 12 after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 24, 2008

First Posted (Estimate)

June 25, 2008

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05562

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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