ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effects of 48 Weeks Versus 24 Weeks of Therapy With Peg-Intron/Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 (Study P04143)(TERMINATED)

This study has been terminated.
( Recruitment targets were unachievable in the currently available population. )

Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00255034
  Purpose

This is an Australian, open-label, multicenter, randomized, double-blind clinical trial designed to assess the efficacy of combination therapy with pegylated interferon alfa-2b and ribavirin for 48 weeks versus 24 weeks in the treatment of chronic hepatitis C (treatment-naïve genotype 3 subjects with high viral loads who have a METAVIR score of at least F1A2). The primary endpoint will be a sustained virological response defined by undetectable HCV RNA in serum at 24 weeks after completion of therapy.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Combination of pegylated interferon alfa-2b and ribavirin
Phase IV

MedlinePlus related topics:   Hepatitis    Hepatitis C   

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

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:   Phase IV Study of Tailored Therapy With Peg Interferon Alfa 2b and Ribavirin for Patients With Genotype 3 and High Viral Load. Genotype 3 Extended Treatment for HCV (GET-C Study)

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Sustained virological response (SVR), defined by undetectable HCV RNA in serum at 24 weeks after completion of therapy [ Time Frame: 24 weeks after completion of either up to 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Log reduction in HCV RNA viral load as a predictor of SVR [ Time Frame: At weeks 2, 4, and 12 of treatment period ] [ Designated as safety issue: No ]
  • Compliance in relation to SVR [ Time Frame: During 24- or 48-week treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment:   624
Study Start Date:   February 2005
Estimated Study Completion Date:   August 2008
Estimated Primary Completion Date:   August 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
24 weeks of therapy: Active Comparator
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
Drug: Combination of pegylated interferon alfa-2b and ribavirin
(a) Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks (g) 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks
48 weeks of therapy: Experimental
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
Drug: Combination of pegylated interferon alfa-2b and ribavirin
(a) Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks (g) 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Comply with all current Australian Schedule of Pharmaceutical Benefits S100 eligibility criteria.
  • Chronic hepatitis C genotype 3 infection with a viral load of at least 2 million copies per mL.
  • Able to give written informed consent.
  • Understand and be able to adhere to the dosing and visit schedules.
  • Compensated liver disease with the following minimum hematologic and biochemical criteria:

    • Hemoglobin ≥120 g/L (females), ≥130 g/L (males)
    • Platelets ≥100 x 109/L
    • Neutrophil count ≥1.5 x 109/L
    • Creatinine clearance >50 mL/minute
    • Thyroid stimulating hormone (TSH) within normal limits
  • Serum hepatitis B surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative.
  • Negative pregnancy test.

Exclusion Criteria:

  • Suspected hypersensitivity to interferon, pegylated interferon alfa-2b, or ribavirin.
  • Participation in any other investigational drug program within 30 days of the screening visit for this protocol.
  • Any cause of liver disease based on patient history and biopsy other than chronic hepatitis C, including but not limited to: hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, autoimmune hepatitis, alcoholic liver disease, drug-related liver disease.
  • Hepatocellular carcinoma.
  • Decompensated cirrhosis (ascites, history of encephalopathy or bleeding varices, serum albumin <35 g/L, prothrombin time (PT) prolonged by greater than 3 sec).
  • Significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, myocardial infarction, severe hypertension, or significant arrhythmia) or participants with an ECG showing clinically significant abnormalities.
  • Immunologically-mediated disease, (e.g. inflammatory bowel disease), idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis).
  • Hemophilia or any hemoglobinopathy, including but not limited to thalassemia major.
  • Severe psychiatric condition, including major depression, a history of major psychoses, current suicidal ideation, and/or suicidal attempts.
  • Ongoing substance abuse, e.g. alcohol, I.V. drugs or inhalants that in the opinion of the investigator would jeopardize the patient's ability to comply with study requirements.
  • Clinically significant ophthalmological disorders.
  • Treatment or recent treatment with immunosuppressive agents (excluding short-term corticosteroid withdrawal) and immunosuppressed transplant recipients.
  • Poorly controlled thyroid disease.
  • Any other condition that in the opinion of the investigator would make the patient unsuitable for enrolment, or could interfere with the patient participating in and completing the clinical trial program.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255034

Sponsors and Collaborators
Schering-Plough

Investigators
Principal Investigator:     Stephen Pianko, MBBS, FRACP     GE Society of Australia    
  More Information


Responsible Party:   Schering-Plough ( Leanne Wall, MD - Medical Director, Australia Country Operations )
Study ID Numbers:   P04143
First Received:   November 15, 2005
Last Updated:   March 20, 2008
ClinicalTrials.gov Identifier:   NCT00255034
Health Authority:   Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Schering-Plough:
chronic hepatitis C  
pegylated interferon alfa-2b  
ribavirin  
Australia  

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-2b
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

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 November 06, 2008




Links to all studies - primarily for crawlers