Induction Dosing With Pegylated Interferon Alfa 2a and Ribavirin in Patients With Chronic Hepatitis C Genotype 1 - Full Text View

Sponsors and Collaborators:	The National Centre in HIV Epidemiology and Clinical Research Hoffmann-La Roche The University of New South Wales
Information provided by:	The National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier:	NCT00192647

Purpose

The purpose of the study is to compare the effectiveness of two treatment regimens in clearing the Hepatitis C Virus in patients infected with Hepatitis C genotype 1.

The study aims to determine whether a higher dose of pegylated interferon given in combination with ribavirin for the first 12 weeks of therapy results in a higher rate of viral clearance and whether it is safe and tolerable.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: pegylated interferon alfa 2a Drug: ribavirin	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferon alfa-n1 Interferon alfa-2a Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IV, Randomised, Multi-Centre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1.

Further study details as provided by The National Centre in HIV Epidemiology and Clinical Research:

Primary Outcome Measures:

To evaluate the effect of peginterferon alfa-2a (Pegasys) plus ribavirin combination therapy induction dosing versus no induction dosing on the clearance of HCV viremia 24 weeks after completion of a 48 week treatment period.

Secondary Outcome Measures:

- To compare the effect of Pegasys plus ribavirin on sustained biochemical response rates

Estimated Enrollment:	816
Study Start Date:	August 2004
Estimated Study Completion Date:	June 2008

Detailed Description:

EFFICACY

Primary Variable:

- Sustained virological response rate defined as percentage of patients with non-detectable qualitative HCV-RNA at 24 weeks post completion of the 48 week treatment period. Response rate will be calculated as the number of patients with a sustained virological response divided by the number of patients who are randomised and received at least one dose of study medication.

Secondary Variables:

- Percentage of patients with non-detectable HCV-RNA and/or 2-log drop in HCV RNA at study week 4, 8, 12, 24 and 48.

SAFETY

- Clinical adverse events, laboratory tests, vital signs

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients >18 and ≤75 years of age
Serologic evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and/or HCV-RNA positive)
HCV Genotype 1
Liver biopsy consistent with CHC (a maximum window of 3 years is permitted between biopsy and study enrolment)
Compensated liver disease, Child Pugh score <7
Serum HCV-RNA >600 IU/mL
Patients who are naïve to any hepatitis C therapy (i.e. have not been previously treated with an interferon or with IFN plus ribavirin)
No clinical or radiological evidence of hepatocellular carcinoma and a serum AFP <100 ng/mL within 2 months of randomisation
Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end

AUSTRALIAN/NEW ZEALAND SITES ONLY:

Patients are not required to have a liver biopsy
Must meet section 100 (AUS) or PHARMAC (NZ) requirements for treatment with Peginterferon alfa-2a and ribavirin

Exclusion Criteria:

Standard exclusion criteria for pegylated interferon and ribavirin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192647

Locations

Australia, New South Wales
Bankstown Hospital
Bankstown, New South Wales, Australia, 2200
Concord Hospital
Concord, New South Wales, Australia, 2137
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Nepean Hospital
Penrith, New South Wales, Australia, 2751
Liverpool Sexual Health Clinic
Liverpool, New South Wales, Australia, 2170
St George Private
Miranda, New South Wales, Australia, 2228
Albion Street Clinic
Surry Hills, New South Wales, Australia, 2010
Lismore Hospital
Lismore, New South Wales, Australia, 2480
Australia, Queensland
Nambour Hospital
Cotton Tree, Queensland, Australia, 4558
Townsville Hospital
Douglas, Queensland, Australia, 4814
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Greenslopes Private Hospital
Brisbane, Queensland, Australia, 4120
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Austin Hospital
Heidelburg, Victoria, Australia, 3084
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Western Hospital
Footscray, Victoria, Australia, 3011
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3065
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Geelong Hospital
Geelong, Victoria, Australia, 3220
Frankston Hospital
Frankston, Victoria, Australia, 3939
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Royal Perth Hospital
Perth, Western Australia, Australia, 6001
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
New Zealand
Auckland Hospital
Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
Christchurch Hospital
Christchurch, New Zealand

Sponsors and Collaborators

The National Centre in HIV Epidemiology and Clinical Research

Hoffmann-La Roche

The University of New South Wales

Investigators

Principal Investigator:

Stuart Roberts, MBBS FRACP

The Alfred Hospital

More Information

National Centre in HIV Epidemiology and Clinical Research Homepage This link exits the ClinicalTrials.gov site

Study ID Numbers:	ML17908
Study First Received:	September 13, 2005
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00192647
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The National Centre in HIV Epidemiology and Clinical Research:

chronic hepatitis C, HCV, genotype 1

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
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
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009