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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C, Chronic Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stage 1 Participants

Participants with CHC receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.

PegIFN-2b

Intervention Type BIOLOGICAL

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

Ribavirin

Intervention Type DRUG

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

Stage 2 Participants

Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.

PegIFN-2b

Intervention Type BIOLOGICAL

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

Ribavirin

Intervention Type DRUG

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

Interventions

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PegIFN-2b

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

Intervention Type BIOLOGICAL

Ribavirin

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

Intervention Type DRUG

Other Intervention Names

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Pegetron® Pegylated interferon alfa-2b PegIntron SCH 054031 SCH 018908

Eligibility Criteria

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Inclusion Criteria

* Treatment-naïve patients with chronic hepatitis C
* Adults (\>18 years of age)
* Prescribed Pegetron Redipen
* Must meet all requirements for treatment with Pegetron Redipen
* Must be able to obtain reimbursement of medication through private or provincial coverage