N/A N=99

Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)

Hepatitis C, Chronic · Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT00728494 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2009

Primary outcome: Primary: The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C — 51; 32 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological); Rebetol (ribavirin; SCH 18908) (Drug); Patient Assistance Program (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C	51; 32	—
PRIMARY The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment	29; 7	—
PRIMARY The Number of Participants Who Relapsed at 6 Months Post-treatment	17; 4	—
SECONDARY Average Length of Treatment	6; 5; 3; 2; 13; 9	—
SECONDARY Average Dosage of PegIntron	1.46; 1.45	—
SECONDARY Average Dosage of Rebetol	12.63; 12.01	—

Summary

Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.

Eligibility Criteria

Inclusion Criteria

According to PegIntron/Rebetol label.
Only HCV genotype 1 infected patients will be enrolled in the study.

Exclusion Criteria

According to PegIntron/Rebetol label.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00728494). 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.