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

NCT00724893 | Completed Results

• 2 other identifiers: P04423MK-4031-267
• Study Type: observational
• Target: 2,430
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C, Chronic; Hepatitis C

Outcome Measures

Primary Outcomes (4)

• Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)

  This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid \[HCV-RNA\]) at either of the follow-up evaluation time points (12 weeks \[window 10-14 weeks\] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response "no".

  Up to 72 weeks

• Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)

  This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no".

  Up to 62 weeks

• Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)

  This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  Up to 72 weeks

• Number of Participants Achieving SVR (Stage 2)

  SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".

  Up to 72 weeks

Secondary Outcomes (48)

• Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)

  Up to 48 weeks

• Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)

  Up to 72 weeks

• Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)

  Up to 62 weeks

• Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)

  Up to 72 weeks

• 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)

  Up to 62 weeks

Study Arms (2)

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.

Biological: PegIFN-2b; Drug: Ribavirin

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.

Biological: PegIFN-2b; Drug: Ribavirin

Interventions

PegIFN-2b BIOLOGICAL

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

Also known as: Pegetron®, Pegylated interferon alfa-2b, PegIntron, SCH 054031

Stage 1 Participants; Stage 2 Participants

Ribavirin DRUG

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

Also known as: SCH 018908

Stage 1 Participants; Stage 2 Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Treatment-naïve patients with chronic hepatitis C undergoing treatment with Pegetron Redipen at approximately 100 centers in Canada.

You may qualify if:

• 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

You may not qualify if:

• Active hepatitis B virus (HBV) infection (hepatitis B surface antigen \[HBsAg\] positive)
• HIV antibody positive
• Post liver transplant patients

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 30, 2008
• Study Start: August 1, 2005
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 14, 2015
• Results First Posted: November 20, 2013

Record last verified: 2015-07