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

• ClinicalTrials.gov Identifier: NCT00255034
• Recruitment Status: Terminated
• First Posted: November 17, 2005
• Results First Posted: July 23, 2009
• Last Update Posted: April 6, 2017
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: November 15, 2005
• First Posted Date: November 17, 2005
• Results First Submitted Date: June 4, 2009
• Results First Posted Date: July 23, 2009
• Last Update Posted Date: April 6, 2017
• Study Start Date: February 2005
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2014)

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 ]

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.

• Original Primary Outcome Measures: Not Provided
• Change History: Complete list of historical versions of study NCT00255034 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of 48 Weeks Versus 24 Weeks of Therapy With Peg-Intron/Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 (Study P04143)(TERMINATED)
• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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
  Other Name: 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 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
• 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

Study Arms

• Active Comparator: 24 weeks of therapy
  Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
  Interventions:

  • Biological: Peginterferon alfa-2b
  • Drug: Ribavirin
• Experimental: 48 weeks of therapy
  Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
  Interventions:

  • Biological: Peginterferon alfa-2b
  • Drug: Ribavirin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 4, 2009): 146
• Original Enrollment (submitted: November 15, 2005): 624
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Australia, New Zealand

Administrative Information

• NCT Number: NCT00255034
• Other Study ID Numbers: P04143
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

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

• Responsible Party: Merck Sharp & Dohme Corp.
• Study Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: March 2017