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

NCT ID: NCT00724854

Last Updated: 2015-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1146 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-09-30

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).

Conditions

Hepatitis C, Chronic; Hepatitis C

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Mono-infected with HCV

Participants infected with Hepatitis C Virus (HCV).

PegIntron (peginterferon alfa-2b; SCH 54031)

Intervention Type: BIOLOGICAL

PegIntron administered in accordance with approved labeling

Rebetol (ribavirin; SCH 18908)

Intervention Type: DRUG

Rebetol administered in accordance with approved labeling

Co-infected with HCV and HIV

Participants co-infected with HCV and Human Immunodeficiency Virus (HIV).

PegIntron (peginterferon alfa-2b; SCH 54031)

Intervention Type: BIOLOGICAL

PegIntron administered in accordance with approved labeling

Rebetol (ribavirin; SCH 18908)

Intervention Type: DRUG

Rebetol administered in accordance with approved labeling

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031)

PegIntron administered in accordance with approved labeling

Intervention Type: BIOLOGICAL

Rebetol (ribavirin; SCH 18908)

Rebetol administered in accordance with approved labeling

Intervention Type: DRUG

Other Intervention Names

SCH 54031; SCH 18908

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 21871496 (View on PubMed)

Other Identifiers

001/05

Identifier Type: -

Identifier Source: secondary_id

P05427

Identifier Type: -

Identifier Source: org_study_id