Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)

March 8, 2017 updated by: Merck Sharp & Dohme LLC

SEASON South East Asian Study Of Novel Genotypes in Hepatitis C Infection: Pegylated-Interferon and Ribavirin Therapy (PEGATRON REDIPEN Combination Therapy (PEG-Intron® REDIPEN Plus REBETOL®)) in Treatment Naive Patients With Genotypes 1, 6, 7, 8, 9: A Comparison of Race and Genotype on Treatment Outcome.

This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. This study is also designed to provide a randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at 24 weeks after therapy completion.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • Able to give written informed consent and adhere to study visit schedule.
  • South East Asian ethnicity (except for Caucasian Gt1/1b in comparator arm) i.e. born in Vietnam, Cambodia, Laos, Thailand, Hong Kong, and China or have both parents born in these countries.
  • Genotype 1, 1a, 1b, 6, 6a, 6b, 7, 8, or 9, as classified by INNO-LiPA assay.
  • Hemoglobin >=120 g/L (females), >=130 g/L (males).
  • Platelet count >=100 x 10^9/L.
  • Neutrophil count >=1.5 x 10^9/L.
  • Negative pregnancy test for females.
  • Thyroid stimulating hormone (TSH) within normal limits.

Exclusion Criteria:

  • Participation in any other investigational drug program within 30 days of the Screening Visit.
  • Human immunodeficiency virus (HIV) antibody positive or hepatitis B surface antigen (HBsAg) positive.
  • Genotype 2, 3, 4, or 5, as classified by INNO-LiPA assay.
  • Non South East Asian ethnicity (unless recruited to Caucasian GT1 comparator arm).
  • Evidence of liver disease due to other disorders (e.g., hemachromatosis, Wilson's disease).
  • Ongoing drug or alcohol abuse which in the opinion of the investigator would jeopardize the patient's ability to comply with study requirements.
  • Inability to comply with study requirements for other reasons.
  • Decompensated cirrhosis (Ascites, history of encephalopathy or bleeding varices, serum albumin <35 g/L, prothrombin time (PT) prolonged by greater than 3 sec).
  • Present or prior history of severe psychiatric disease requiring hospitalization or medication.
  • History of severe seizure disorder.
  • History of autoimmune disorders (e.g., rheumatoid arthritis, inflammatory bowel disease, immune thrombocytopenic purpura, systemic lupus erythematosus, or other mixed connective tissue disease, psoriasis, optic neuritis).
  • Poorly controlled thyroid disease.
  • Creatinine clearance <50 mL/min.
  • Severe cardiovascular disease.
  • Hepatocellular cancer.
  • Clinically significant ophthalmologic disorders.
  • Hemoglobinopathies (e.g., thalassemia, sickle-cell anemia).
  • Treatment or recent treatment with immunosuppressive agents (excluding short-term corticosteroid withdrawal), and immunosuppressed transplant recipients scheme.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Genotype 1 SEA PEG-IFN/RIB 48 w
Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PEG-Intron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
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 REDIPEN
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
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 REDIPEN
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
Active Comparator: Genotype 1 Caucasian PEG-IFN/RIB 48 w
Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
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 REDIPEN
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
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 REDIPEN
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
Experimental: Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
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 REDIPEN
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
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 REDIPEN
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
Active Comparator: Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
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 REDIPEN
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
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 REDIPEN
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Achieved a Sustained Virologic Response (SVR)
Time Frame: 24 weeks after completion of either up to 24 or 48 weeks of therapy
SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed.
24 weeks after completion of either up to 24 or 48 weeks of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04212

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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