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)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 146
- 主要终点
- Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy
研究概览
简要总结
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.
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.
- •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.
排除标准
- •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.
研究组 & 干预措施
24 weeks of therapy
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
干预措施: Ribavirin (Drug)
24 weeks of therapy
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
干预措施: Peginterferon alfa-2b (Biological)
48 weeks of therapy
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
干预措施: Peginterferon alfa-2b (Biological)
48 weeks of therapy
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy
时间窗: 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.
次要结局
未报告次要终点