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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Biological: Peginterferon alfa-2b; Biological: Peginterferon alfa-2b; Drug: Ribavirin; Drug: Ribavirin

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: SCH 54031, PegIntron; 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 Names: 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 Names: SCH 18908 Rebetol; Drug: Ribavirin; 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks; Other Names: 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 24 weeks; Other Names: SCH 54031, PegIntron; 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 Names: 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 Names: SCH 18908 Rebetol; Drug: Ribavirin; 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks; Other Names: SCH 18908 Rebetol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: November 15, 2005
• First Submitted That Met QC Criteria: November 15, 2005
• First Posted (Estimate): November 17, 2005

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: ribavirin; Australia; chronic hepatitis C; pegylated interferon alfa-2b
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Immunologic Factors; Interferon-alpha; Ribavirin; Peginterferon alfa-2b
• Other Study ID Numbers: P04143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php