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Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)

NCT00724893 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2430

Last updated 2015-08-14

Study results available
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Summary

Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b \[PegIFN-2b\] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.

Conditions

  • Hepatitis C, Chronic
  • Hepatitis C

Interventions

BIOLOGICAL

PegIFN-2b

PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen. Dosing per approved labeling

DRUG

Ribavirin

Ribavirin capsules administered orally. Dosing in accordance with approved labelling.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00724893 on ClinicalTrials.gov