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

NCT00255034 | Terminated Phase 4 Results

• 1 other identifier: P04143
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis C, Chronic

Keywords

chronic hepatitis C; pegylated interferon alfa-2b; ribavirin; Australia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

24 weeks of therapy

ACTIVE COMPARATOR

Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks

Biological: Peginterferon alfa-2b; Drug: Ribavirin

48 weeks of therapy

EXPERIMENTAL

Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks

Biological: Peginterferon alfa-2b; Drug: Ribavirin

Interventions

Peginterferon alfa-2b BIOLOGICAL

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

Also known as: SCH 54031, PegIntron

24 weeks of therapy

Ribavirin DRUG

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

Also known as: SCH 18908 Rebetol

24 weeks of therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

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.

Results Point of Contact

• Title: Senior Vice Predsident, Global Clinical Development
• Organization: Merck, Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 17, 2005
• Study Start: February 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 6, 2017
• Results First Posted: July 23, 2009

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share