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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724854
First received: July 25, 2008
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention
Hepatitis C, Chronic
Hepatitis C
Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
Drug: Rebetol (ribavirin; SCH 18908)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Rapid Virological Response in HCV Patients Treated With PegIntron and Ribavirin - APEGIN Trial

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment [ Time Frame: Assessed at Treatment Week 4 ] [ Designated as safety issue: No ]
    Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.


Secondary Outcome Measures:
  • Number of Participants Who Achieved Sustained Virologic Response (SVR) [ Time Frame: Assessed at 24 weeks post-treatment ] [ Designated as safety issue: No ]
    SVR was defined as non-detectable HCV RNA 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) ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Assessment of Baseline Characteristics in Participants With SVR [ Time Frame: 24 Weeks post-treatment ] [ Designated as safety issue: No ]
    Baseline characteristics assessed were age, gender, and genotype.


Enrollment: 1146
Study Start Date: August 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered in accordance with approved labeling
Other Name: 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 Name: SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered in accordance with approved labeling
Other Name: SCH 18908

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724854     History of Changes
Other Study ID Numbers: P05427, 001/05
Study First Received: July 25, 2008
Results First Received: December 23, 2010
Last Updated: March 7, 2014
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014