NCT00624325已完成2 期
Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders
Foundation for Liver Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and tolerability of high-dose continuous subcutaneous infused IFN-a2b (serious adverse events, grade 4 NCI toxicity, percentage of patients completing treatment or reasons for dose adjustments).
研究概览
简要总结
For chronic hepatitis C patients unresponsive to previous (PEG-)IFN/RBV combination therapy we propose continuous subcutaneous administration of high-dose IFN-a2b (Intron A®) for 48 weeks in combination with 15 mg/kg/day RBV (Rebetol®) and optimal management of side effects in order to maintain the highest possible dosages of both IFN-a2b and RBV for 48 weeks. We expect improved tolerability with continuous subcutaneous pump delivery of IFN-a2b compared to thrice weekly or daily subcutaneous injection of IFN-a2b, and increased antiviral activity and biologic potency due to sustained and higher levels of a fully potent interferon protein.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatitis C genotype 1 unresponsive to (peg)interferon /ribavirin therapy
- •In the past, peginterferon or conventional interferon plus ribavirin combination therapy for at least 12 weeks and less than 2-log HCV RNA decrease at week 12, HCV RNA positivity at week 24, breakthrough during therapy or relapse after therapy
- •At least 12 weeks between end of (peg)interferon/ribavirin therapy and start of high-dose IFN/ribavirin therapy
- •Persistent indication for antiviral therapy such as persistently elevated serum ALT or histological evidence of continuing or progressive fibrosis
- •Age 18-60 years
排除标准
- •Signs of progressive liver disease since end of previous therapy, beyond generally accepted criteria for HCV antiviral therapy:
- •serum bilirubin >35 μmol/l, albumin <36 g/l, prothrombin time >4 sec prolonged or platelets <100,000/mm3
- •decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, gastric bleeding, esophageal varices or encephalopathy)
- •Hepatic imaging (US, CT or MRI) with the evidence of hepatocellular carcinoma (hepatic imaging should be performed within 3 months prior to screening) or an alpha fetoprotein >50 ng/ml
- •Other acquired or inherited causes of liver disease that could explain liver disease activity
- •Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
- •Other significant medical illness that might interfere with this study: significant cardiovascular, pulmonary or renal dysfunction, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g.: HIV positivity, steroid therapy, organ transplants other than cornea and hair transplant)
- •History of a severe seizure disorder or current anticonvulsant use
- •History of thyroid disease poorly controlled on prescribed medications
- •Contra-indications for IFN and/or ribavirin:
- •Severe psychiatric disorder, such as major psychoses, suicidal ideation, suicidal attempt and/or manifest depression during previous (peg)interferon therapy. Severe depression would include the following: (a) subjects who have been hospitalized for depression, (b) subjects who have received electroconvulsive therapy for depression, or (c) subjects whose depression has resulted in a prolonged absence of work and/or significant disruption of daily functions. Subjects with a history of mild depression may be considered for entry into the protocol provided that a pretreatment assessment of the subject's mental status supports that the subject is clinically stable and that there is ongoing evaluation of the patient's mental status during the study
- •Reactivation of immunological disorders during previous therapy
- •Visual symptoms related to retinal abnormalities
- •Pregnancy, breast-feeding or inadequate contraception
- •Thalassemia, spherocytosis
- •Substance abuse, such as alcohol (³80 gm/day) and I.V. drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 years
- •Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
研究组 & 干预措施
1
Experimental
12 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
干预措施: interferon alfa-2b (Drug)
2
Experimental
9 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
干预措施: interferon alfa-2b (Drug)
3
Experimental
6 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin
干预措施: interferon alfa-2b (Drug)
结局指标
主要结局
Safety and tolerability of high-dose continuous subcutaneous infused IFN-a2b (serious adverse events, grade 4 NCI toxicity, percentage of patients completing treatment or reasons for dose adjustments).
时间窗: 48 weeks
次要结局
- HCV RNA negativity at week 48 and 24 weeks after end of treatment(48 weeks)
- Biological activity of IFN-a2b(48 weeks)
- Pharmacokinetics by IFN-a2b levels(48 weeks)
- HCV-specific immune responses(48 weeks)
- Quality of life assessment using SF-36 and SCL-90 questionnaires(48 weeks)
研究者
研究点 (1)
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