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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00475072
First received: May 16, 2007
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Safety and Effect on Sustained Virological Response of PEGASYS Plus Ribavirin in Patients With Hemophilia A and Chronic Hepatitis C

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • SVR [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: June 2003
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
Drug: ribavirin
1000/1200mg po daily for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male patients, >=18 years of age;
  • hemophilia A;
  • chronic hepatitis C;
  • compensated liver disease.

Exclusion Criteria:

  • therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months before start of study drug;
  • hepatitis A, hepatitis B or HIV infection;
  • chronic liver disease other than chronic hepatitis C.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475072

Locations
Mexico
Mexico City, Mexico, 02990
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00475072     History of Changes
Other Study ID Numbers: ML16814
Study First Received: May 16, 2007
Last Updated: June 3, 2013
Health Authority: Mexico: Secretaria de Salud

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
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 June 18, 2013