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: April 29, 2014
Last verified: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 29, 2014
Health Authority: Brazil: National Health Surveillance Agency

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

ClinicalTrials.gov processed this record on October 23, 2014