Clinical trial NCT00724893: Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)
Official title: Pegetron® Redipen™ Prospective Optimal Weight-based Dosing Response Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 2430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Treatment-naïve patients with chronic hepatitis C undergoing treatment with Pegetron Redipen at approximately 100 centers in Canada.

Brief 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.


Eligibility criteria: 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

Exclusion Criteria:

* Active hepatitis B virus (HBV) infection (hepatitis B surface antigen \[HBsAg\] positive)
* HIV antibody positive
* Post liver transplant patients
* Any other exclusion criteria as per the product Monograph

Primary outcomes:
measure: Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)
timeFrame: Up to 62 weeks
measure: Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving SVR (Stage 2)
timeFrame: Up to 72 weeks
Secondary outcomes:
measure: Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)
timeFrame: Up to 48 weeks
measure: Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)
timeFrame: Up to 62 weeks
measure: Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)
timeFrame: Up to 72 weeks
measure: The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)
timeFrame: Up to 62 weeks
measure: The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)
timeFrame: Up to 72 weeks
measure: The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)
timeFrame: Up to 62 weeks
measure: The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)
timeFrame: Up to 62 weeks
measure: Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving SVR by Viral Load (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving SVR by Weight (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving EVR (Stage 1)
timeFrame: From Week 10 to Week 14
measure: Number of Participants Achieving SVR by EVR Type (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving SVR by Gender (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving SVR by Race (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants With End of Treatment (EOT) Response (Stage 1)
timeFrame: Up to 48 weeks
measure: Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)
timeFrame: Up to 72 weeks
measure: Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)
timeFrame: Week 12
measure: Relapse Rate by HCV Genotype (Stage 1)
timeFrame: Up to 48 weeks
measure: Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)
timeFrame: Up to 48 weeks
measure: Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)
timeFrame: Week 4
measure: Number of Participants Achieving EVR (Stage 2)
timeFrame: Week 12
measure: Number of Participants Achieving RVR by Race (Stage 2)
timeFrame: Week 4
measure: Number of Participants Achieving EVR by Race (Stage 2)
timeFrame: Week 12
measure: Number of Participants Achieving SVR by Race (Stage 2)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving RVR Who Achieved SVR (Stage 2)
timeFrame: Week 4
measure: Number of Participants Achieving EVR Who Achieved SVR (Stage 2)
timeFrame: Week 12
measure: Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)
timeFrame: Week 4
measure: Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)
timeFrame: Week 12
measure: Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving RVR by Weight (Stage 2)
timeFrame: Week 4
measure: Number of Participants Achieving EVR by Weight (Stage 2)
timeFrame: Week 12
measure: Number of Participants Achieving SVR by Weight (Stage 2)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)
timeFrame: Week 4
measure: Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)
timeFrame: Week 12
measure: Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving RVR by Gender (Stage 2)
timeFrame: Week 4
measure: Number of Participants Achieving EVR by Gender (Stage 2)
timeFrame: Week 12
measure: Number of Participants Achieving SVR by Gender (Stage 2)
timeFrame: Up to 72 weeks
measure: Number of Participants Achieving RVR by HIV Status (Stage 2)
timeFrame: Week 4
measure: Number of Participants Achieving EVR by HIV Status (Stage 2)
timeFrame: Week 12
measure: Number of Participants Achieving SVR by HIV Status (Stage 2)
timeFrame: Up to 72 weeks
measure: Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)
timeFrame: Up to 72 weeks
Other outcomes:
Locations:
Study officials:
References: