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

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
The University of New South Wales
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00192647
First received: September 13, 2005
Last updated: June 1, 2011
Last verified: June 2011
  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: high dose peg-ifn plus rbv
Drug: standard peg-ifn plus ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

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. [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 896
Study Start Date: August 2004
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Standard dosing peg-ifn plus rbv
Drug: standard peg-ifn plus ribavirin
PEG-IFN: 180 mcg daily subcutaneously RBV: standard weight based dosing taken orally, daily in split doses
Experimental: 1
induction dosing peg-ifn plus rbv
Drug: high dose peg-ifn plus rbv
PEG-IFN: 360 mcg daily subcutaneously RBV: standard weight based dosing taken orally, daily in split doses

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia, New South Wales
Bankstown Hospital
Bankstown, New South Wales, Australia, 2200
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Concord Hospital
Concord, New South Wales, Australia, 2137
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Lismore Hospital
Lismore, New South Wales, Australia, 2480
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Liverpool Sexual Health Clinic
Liverpool, New South Wales, Australia, 2170
St George Private
Miranda, New South Wales, Australia, 2228
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
Nepean Hospital
Penrith, New South Wales, Australia, 2751
Albion Street Clinic
Surry Hills, New South Wales, Australia, 2010
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Greenslopes Private Hospital
Brisbane, Queensland, Australia, 4120
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
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Monash Medical Centre
Clayton, Victoria, Australia, 3168
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Western Hospital
Footscray, Victoria, Australia, 3011
Frankston Hospital
Frankston, Victoria, Australia, 3939
Geelong Hospital
Geelong, Victoria, Australia, 3220
Austin Hospital
Heidelburg, Victoria, Australia, 3084
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3065
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6001
New Zealand
Auckland Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Waikato Hospital
Hamilton, New Zealand
Sponsors and Collaborators
Kirby Institute
Hoffmann-La Roche
The University of New South Wales
Investigators
Principal Investigator: Stuart Roberts, MBBS FRACP The Alfred Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Stuart Roberts, The Alfred Hospital
ClinicalTrials.gov Identifier: NCT00192647     History of Changes
Other Study ID Numbers: ML17908
Study First Received: September 13, 2005
Last Updated: June 1, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Kirby Institute:
chronic hepatitis C, HCV, genotype 1

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

ClinicalTrials.gov processed this record on October 19, 2014