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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: peginterferon alfa-2b (Biological); ribavirin (Drug); peginterferon alfa-2b (Biological); ribavirin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.


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.

Clinical Details

Official title: 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.

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

Primary outcome: Number of Subjects Who Achieved a Sustained Virologic Response (SVR)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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.

Locations and Contacts

Additional Information

Starting date: March 2005
Last updated: February 4, 2015

Page last updated: August 23, 2015

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