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.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 121
- 主要终点
- Number of Subjects Who Achieved a Sustained Virologic Response (SVR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: peginterferon alfa-2b (Biological)
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
干预措施: ribavirin (Drug)
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
干预措施: peginterferon alfa-2b (Biological)
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
干预措施: ribavirin (Drug)
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
干预措施: peginterferon alfa-2b (Biological)
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
干预措施: ribavirin (Drug)
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
干预措施: peginterferon alfa-2b (Biological)
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
干预措施: ribavirin (Drug)
结局指标
主要结局
Number of Subjects Who Achieved a Sustained Virologic Response (SVR)
时间窗: 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.
次要结局
未报告次要终点