Clinical trial NCT00724854: Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)
Official title: Evaluation of Rapid Virological Response in HCV Patients Treated With PegIntron and Ribavirin - APEGIN Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 1146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

Brief 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).


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

Primary outcomes:
measure: Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment
timeFrame: Assessed at Treatment Week 4
Secondary outcomes:
measure: Number of Participants Who Achieved Sustained Virologic Response (SVR)
timeFrame: Assessed at 24 weeks post-treatment
measure: Number of Participants With RVR Who Also Achieved SVR
timeFrame: Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)
measure: 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
timeFrame: Treatment Week 48 and Treatment Week 72
measure: Assessment of Baseline Characteristics in Participants With SVR
timeFrame: 24 Weeks post-treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Santos C, Reis A, Dos Santos CV, Damas C, Silva MH, Viana MV, Ferraz ML, Carnauba D, El-Far F, Serra F, Diaz RS. The use of real-time PCR to detect hepatitis C virus RNA in dried blood spots from Brazilian patients infected chronically. J Virol Methods. 2012 Jan;179(1):17-20. doi: 10.1016/j.jviromet.2011.06.012. Epub 2011 Jun 24.