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

Hepatitis C Clinical Trial

— APEGIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724854
• Other study ID #: P05427
• Secondary ID: 001/05
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: February 6, 2015
• Start date: August 2006
• Est. completion date: September 2009

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1146
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Biological:
• PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron administered in accordance with approved labeling

Drug:
• Rebetol (ribavirin; SCH 18908)
Rebetol administered in accordance with approved labeling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants Who Achieved Sustained Virologic Response (SVR)	SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.	Assessed at 24 weeks post-treatment	No
Secondary	Number of Participants With RVR Who Also Achieved 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.	Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)	No
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	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.	Treatment Week 48 and Treatment Week 72	No
Secondary	Assessment of Baseline Characteristics in Participants With SVR	Baseline characteristics assessed were age, gender, and genotype.	24 Weeks post-treatment	No