NCT00127777Unknown4 期
Randomized, Multi-Center, Partially Placebo-Controlled Phase IV-Study to Compare Efficacy and Tolerability of 48-Week Combined Therapy With Peginterferon Alfa-2a, Ribavirin and Amantadine Sulphate Versus Placebo in Untreated Patients With Chronic Hepatitis C Virus-Genotype-1-Infection
University Hospital, Saarland0 个研究点目标入组 700 人开始时间: 2002年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 700
- 主要终点
- Proof that peginterferon alfa-2a, ribavirin and amantadine sulphate over a period of 50 weeks improves the permanent virological efficacy by more than 10% compared to peginterferon alfa-2a and ribavirin
研究概览
简要总结
This was a randomized, multi-center, partially placebo-controlled Phase IV study to compare the efficacy and tolerability of a 48-week combined therapy with pegylated interferon alpha-2a, ribavirin and amantadine sulphate versus placebo in untreated patients with chronic hepatitis C virus-genotype-1-infection. The hypothesis was that there will be an increase in sustained response rate for triple therapy compared to current standard treatment.
详细描述
Primary Objective:
- Proof that a triple-therapy (peginterferon alfa-2a, ribavirin and amantadine sulphate) dispensed over a period of 50 weeks, improves the permanent virological efficacy by more than 10% as compared to a combination therapy with peginterferon alpha-2a and ribavirin, defined as negative HCV-RNA result obtained by a molecular verification method (e.g. Roche AmplicorTM HCV, v.2.0, sensitivity <50 IE/ml) 24 weeks after the end of the therapy.
Secondary Objectives:
- Verification of the initial virological efficacy up to week 12, defined as negative HCV-RNA test results by means of quantitative proof methods, e.g. Roche AmplicorTM HCV Monitor v.2.0 (sensitivity <600 IE/ml).
- Biochemical efficacy, defined by the serum GPT values 24 weeks after the end of the therapy.
- Virological efficacy, measured on the basis of the HCV-RNA values at the end of the therapy.
- Biochemical efficacy defined by the serum GPT values at the end of the therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male subjects over 18 years of age and below 70 years of age
- •Serological indication of chronic hepatitis C infection with positive anti-HCV test and serum HCV-RNA quantification >600 IE/ml by means of quantitative proof methods, e.g. Roche AmplicorTM HCV Monitor test, v.2.
- •Untreated patients with HCV-induced chronic infection.
- •Indication of a genotype HCV-1 on the basis of the reverse hybridizing assay Inno LiPA from Bayer Versant (Innogenetics).
- •Increased GPT serum level on at least one determination date within the 56-day screening phase prior to start of administration of study medication.
- •Histological identification of inflammatory activity in the liver, with or without an indication of compensated cirrhosis, during the 24 months prior to start of the study.
- •Compensated liver disease (Child-Pugh Grade A).
- •Negative urine or serum pregnancy test in fertile female subjects within 24 hours before taking the first dose of study medication.
- •During the administration of study medication and for 24 weeks after the treatment has stopped, patients must apply two approved contraception methods, one of which must have a barrier effect on the male, e.g. condom.
- •If one or more of the above inclusion criteria are not fulfilled, the patient is excluded from the study!
排除标准
- •Any known sensitive reaction to interferon, ribavirin or amantadine sulphate.
- •Pregnant or breast-feeding women and fertile women who do not practice contraception.
- •Male partners of pregnant women.
- •Previous treatment with interferon and/or ribavirin.
- •Treatment with systemic anti-neoplastic or immunomodulatory medication (supraphysiologic doses of steroids or radiation included) within the last 6 months prior to the study and throughout the whole study.
- •Immunosuppressed/immunocompromised patients.
- •Participation in a clinical study within the last three months.
- •Infection with HCV genotype-2, -3, -4, -5 or -
- •Positive indication of HBsAg, HIV antibodies in the screening phase.
- •Non-hepatitis C virus-induced chronic hepatitis (e.g. hematochromatosis, autoimmune hepatitis, metabolic or alcoholic liver disease).
- •Decompensated liver cirrhosis or liver disease; Child-Pugh Grade B or C; or threshold compensated liver disease.
- •Signs of a hepatocellular carcinoma within 2 months before the randomization, coupled with existing or developing cirrhosis.
- •History of oesophagus varices haemorrhage.
- •Hemoglobin <12 g/dl in female subjects and <13 g/dl in male subjects in the screening phase.
- •Subjects with a higher risk of anemia (e.g. thalassemia, spherocytosis, history of gastrointestinal bleeding) or subjects for whom anemia could be a highly potential medical risk.
- •Neutropenia <1500 /µl or thrombocytopenia <90,000 /µl diagnosed in the screening phase.
- •Serum creatinine >1.5 mg/dl in the screening phase.
- •History of severe psychiatric diseases, especially severe depression, whereby severe psychiatric disease is defined as any anti-depressive or anti-psychotic therapy of at least 3 months in the history, or any indication of suicidal inclination or hospitalization caused by a psychiatric disease.
- •Epilepsy.
- •Autoimmune disease (e.g. inflammatory intestinal diseases, idiopathic thrombocytopenic purpura, lupus erythematosus sclerodermia, severe psoriasis, rheumatoid arthritis, etc.).
- •History of thyroid disease, poorly controlled by prescribed medications
- •Chronic pulmonary disease with functional restriction.
- •History of severe cardiac disease, e.g. cardiac insufficiency New York Heart Association (NYHA) class III or IV; myocardial infarction within the last 6 months; ventricular tachyarrhythmia requiring treatment; unstable angina pectoris; cerebrovascular circulation disorders; or other significant cardiovascular diseases.
- •Patients with pacemakers.
- •Cardiomyopathy and myocarditis
- •Atrioventricular (AV)-block Grade II and III.
- •Previously known bradycardia rating under 55 strokes/minute
- •Known, lengthy QT-interval (QTc as per Bazett > 420 ms) or recognizable U waves or hereditary QT-syndrome in the family history.
- •History of a severe ventricular arrythmia including Torsade de pointes.
- •Simultaneous therapy with budipine or other QT-extending medication such as:
- •Certain antiarrhythmias of class IA (e.g. quinidine, disopyramide, procainamide) and class III (such as amiodarone, sotalol);
- •Certain antipsychotics (e.g. thioridazine, chlorpromazine, haloperidol, pimozide);
- •Certain tri- and tetracyclic anti-depressive medications (e.g. amitriptyline);
- •Certain antihistaminic medications (e.g. astemizol, terfenadin);
- •Certain macrolide antibiotics (e.g. erythromycin, clarithromycin);
- •Certain gyrase inhibitors (e.g. sparfloxacin);
- •Azole-antimycotics and other medications such as halofantrine, cotrimoxazol, pentamidine, cisapride or bepridil;
- •Simultaneous treatment with Memantine.
- •Morbus Parkinson.
- •History of major organ transplantations, with the exception of cornea transplantation.
- •Cancer or any other disease, which, in the opinion of the investigator, is an exclusion criterion for the study.
- •Evidence of severe retinopathy (e.g. cytomegalovirus [CMV] retinitis or macular degeneration).
- •Patients with narrow-angle glaucoma.
- •Active drug abuse (excessive alcohol consumption included) within the last year prior to study (with the exception of a prescribed substitute).
- •Patients with state of agitation or confusion
- •Patients with a history of acute brain syndrome or exogenous psychosis
- •Patients are already enrolled in the study.
- •Prostate hypertrophy
- •Simultaneous administering of diuretics of combination type triamterene/hydrochlorothiazide.
- •Unwillingness or incapability to give written consent after receiving medical information; doubts about the proper protection of patient data; and general reluctance to take part in the study and to adhere to the study terms.
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结局指标
主要结局
Proof that peginterferon alfa-2a, ribavirin and amantadine sulphate over a period of 50 weeks improves the permanent virological efficacy by more than 10% compared to peginterferon alfa-2a and ribavirin
次要结局
- Verification of the initial virological efficacy up to week 12, defined as negative HCV-RNA test results by means of quantitative proof methods, e.g. Roche AmplicorTM HCV Monitor v.2.0 (sensitivity <600 IE/ml)
- Biochemical efficacy, defined by the serum GPT values 24 weeks after the end of the therapy
- Virological efficacy, measured on the basis of the HCV-RNA values at the end of the therapy
- Biochemical efficacy defined by the serum GPT values at the end of the therapy
研究者
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