Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427) (APEGIN)

February 6, 2015 updated by: Merck Sharp & Dohme LLC

Evaluation of Rapid Virological Response in HCV Patients Treated With PegIntron and Ribavirin - APEGIN Trial

The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. The study will also assess whether RVR is a reliable predictor of sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1146

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants infected with Hepatitis C Virus (HCV) who are undergoing treatment with PegIntron and Rebetol in accordance with approved labeling at approximately 60 sites in Brazil. Participants could be treatment-naïve, undergoing re-treatment, or co-infected with Human Immunodeficiency Virus (HIV).

Description

Inclusion Criteria:

  • Willing to participate in the study and sign the Informed Consent Form
  • Established HCV infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction [PCR] test)
  • Can be treatment-naïve, have retreatment, or co-infected with HIV
  • Be under treatment with PegIntron in combination with ribavirin, starting up to 14 days before the screening visit

Exclusion Criteria:

  • Participants who have not confirmed their willingness to participate in the study or have refused to sign the Free and Informed Consent Form
  • Prior treatment with PegIntron (combined with ribavirin or not)
  • History of alcohol abuse in the past 6 months
  • Decompensated liver disease
  • Severe heart disease
  • Decompensated thyroid disorder
  • Neoplasia
  • Type 1 diabetes mellitus - uncontrolled or hardly controlled
  • Seizures - uncontrolled
  • Primary immune deficiency
  • Men and women not using appropriate contraceptive methods
  • Pregnancy or lactation
  • For participants co-infected with HIV: HIV-related opportunistic disease in the past 6 months or CD4 count lower than 200 cells/mm^3

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
Mono-infected with HCV
Participants infected with Hepatitis C Virus (HCV).
Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron administered in accordance with approved labeling
Other Names:
  • SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered in accordance with approved labeling
Other Names:
  • SCH 18908
Co-infected with HCV and HIV
Participants co-infected with HCV and Human Immunodeficiency Virus (HIV).
Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron administered in accordance with approved labeling
Other Names:
  • SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered in accordance with approved labeling
Other Names:
  • SCH 18908

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment
Time Frame: Assessed at Treatment Week 4
Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.
Assessed at Treatment Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Achieved Sustained Virologic Response (SVR)
Time Frame: Assessed at 24 weeks post-treatment
SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.
Assessed at 24 weeks post-treatment
Number of Participants With RVR Who Also Achieved SVR
Time Frame: Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)
RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment.
Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)
Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR
Time Frame: Treatment Week 48 and Treatment Week 72
Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5.
Treatment Week 48 and Treatment Week 72
Assessment of Baseline Characteristics in Participants With SVR
Time Frame: 24 Weeks post-treatment
Baseline characteristics assessed were age, gender, and genotype.
24 Weeks post-treatment

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2006

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (ESTIMATE)

July 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05427
  • 001/05

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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