N/A
Completed N=1,082
Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)
Hepatitis C, Chronic · Hepatitis C
Source: ClinicalTrials.gov NCT00724854 ↗
Enrolled (actual)
1,082
Serious AEs
5.2%
Results posted
Jan 2011
Primary outcomePrimary: Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment — 551; 32 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment |
551; 32 | — |
| SECONDARY Number of Participants Who Achieved Sustained Virologic Response (SVR) |
375; 24 | — |
| SECONDARY Number of Participants With RVR Who Also Achieved SVR |
300; 19 | — |
| SECONDARY 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 |
251; 13; 300; 19 | — |
| SECONDARY Assessment of Baseline Characteristics in Participants With SVR |
75; 11; 300; 13; 203; 17 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00724854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.