Effects of 48 Weeks Versus 24 Weeks of Therapy With Peg-Intron/Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 (Study P04143)(TERMINATED)

Hepatitis C, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00255034
• Other study ID #: P04143
• Status: Terminated
• Phase: Phase 4
• First received: November 15, 2005
• Last updated: March 30, 2015
• Start date: February 2005
• Est. completion date: June 2008

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 146
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

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
• 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

Drug:
• Ribavirin
200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 weeks
• Ribavirin
200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy	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.	24 weeks after completion of either up to 24 or 48 weeks of therapy	No