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Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423 AM4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00724893
First received: July 25, 2008
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C 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 HCV-RNA six months post-treatment.


Condition Intervention
Hepatitis C, Chronic
Hepatitis C
 Biological: Peginterferon alfa-2b
Drug: Ribavirin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pegetron® Redipen™ Prospective Optimal Weight-based Dosing Response Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of participants with sustained virologic response (SVR) [ Time Frame: 24 weeks post-treatment (up to 72 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants discontinued from study due to adverse events [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with SVR based on specific demographic characteristics including but not limited to weight, fibrosis level, age, genotype, and race [ Time Frame: 24 weeks post-treatment (up to 72 weeks) ] [ Designated as safety issue: No ]
  • Score on the Medication Adherence Questionnaire [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 1100
Study Start Date: August 2005
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants
Participants receiving Peginterferon alfa-2b according to routine medical practice at participating study sites.
 Biological: Peginterferon alfa-2b
Peginterferon alfa-2b powder for solution administered subcutaneously using the newly approved Redipen. Dosing per approved labeling.
Other Name: SCH 054031
Drug: Ribavirin
Ribavarin capsules administered orally. Dosing in accordance with approved labeling.
Other Name: SCH 018908

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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 HBV infection (HBsAg positive)
  • HIV antibody positive
  • Post liver transplant patients
  • Any other exclusion criteria as per the product Monograph
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00724893     History of Changes
Other Study ID Numbers: P04423
Study First Received: July 25, 2008
Last Updated: September 14, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013