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Completed

NCT Number: NCT00724854

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

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).

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PegIntron (peginterferon alfa-2b; SCH 54031)

Biological

PegIntron administered in accordance with approved labeling

Other names: SCH 54031

REBETOL (ribavirin; SCH 18908)

Drug

Rebetol administered in accordance with approved labeling

Other names: SCH 18908

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Assessment of Baseline Characteristics in Participants With SVR

    Time frame: 24 Weeks post-treatment

    Baseline characteristics assessed were age, gender, and genotype.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Acronym: APEGIN

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jul 30, 2008
Registry last updated
Feb 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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