We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00724854
First Posted: July 30, 2008
Last Update Posted: February 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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 ]
    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 ]
    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) ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
First Submitted: July 25, 2008
First Posted: July 30, 2008
Results First Submitted: December 23, 2010
Results First Posted: January 10, 2011
Last Update Posted: February 25, 2015
Last Verified: February 2015

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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs