Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)
APEGIN
Evaluation of Rapid Virological Response in HCV Patients Treated With PegIntron and Ribavirin - APEGIN Trial
2 other identifiers
observational
1,146
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2006
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
January 10, 2011
CompletedFebruary 25, 2015
February 1, 2015
3.1 years
July 25, 2008
December 23, 2010
February 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment
Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.
Assessed at Treatment Week 4
Secondary Outcomes (4)
Number of Participants Who Achieved Sustained Virologic Response (SVR)
Assessed at 24 weeks post-treatment
Number of Participants With RVR Who Also Achieved SVR
Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)
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
Treatment Week 48 and Treatment Week 72
Assessment of Baseline Characteristics in Participants With SVR
24 Weeks post-treatment
Study Arms (2)
Mono-infected with HCV
Participants infected with Hepatitis C Virus (HCV).
Co-infected with HCV and HIV
Participants co-infected with HCV and Human Immunodeficiency Virus (HIV).
Interventions
PegIntron administered in accordance with approved labeling
Rebetol administered in accordance with approved labeling
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 21871496RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 30, 2008
Study Start
August 1, 2006
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
February 25, 2015
Results First Posted
January 10, 2011
Record last verified: 2015-02