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.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00255034
First received: November 15, 2005
Last updated: April 28, 2014
Last verified: April 2014
  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
Biological: Peginterferon alfa-2b
Drug: 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: 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]
    No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfill the recruitment target.


Enrollment: 146
Study Start Date: February 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 24 weeks of therapy
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
Biological: Peginterferon alfa-2b
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 weeks
Other Name: SCH 54031, PegIntron
Drug: Ribavirin
200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 weeks
Other Name: SCH 18908 Rebetol
Experimental: 48 weeks of therapy
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
Biological: Peginterferon alfa-2b
Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
Other Name: SCH 54031 PegIntron
Drug: Ribavirin
200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks
Other Name: SCH 18908 Rebetol

  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 10^9/L
    • Neutrophil count ≥1.5 x 10^9/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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00255034     History of Changes
Other Study ID Numbers: P04143
Study First Received: November 15, 2005
Results First Received: June 4, 2009
Last Updated: April 28, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Merck Sharp & Dohme Corp.:
chronic hepatitis C
pegylated interferon alfa-2b
ribavirin
Australia

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
Ribavirin
Interferon-alpha
Peginterferon alfa-2b
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014