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

This study has been completed.

First Received: May 16, 2007 Last Updated: April 15, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00475072

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 (40KD) [PEGASYS] Drug: ribavirin	Phase IV

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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 Completion Date:	July 2006

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [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, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML16814
Study First Received:	May 16, 2007
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00475072 History of Changes
Health Authority:	Mexico: Secretaria de Salud

Study placed in the following topic categories:

Antimetabolites
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Hemophilia A
Ribavirin
Hepatitis, Viral, Human
Angiogenesis Inhibitors

Antiviral Agents
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Liver Diseases
Flaviviridae Infections
Hepatitis, Chronic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents

Growth Inhibitors
RNA Virus Infections
Growth Substances
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2a
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on May 07, 2009