EUCTR2013-003763-56-IT进行中（未招募）1 期
Proof of Concept Study of Eurartesim® in Patients with Imported Uncomplicated Plasmodium Vivax Malaria - Evaluation of efficacy and safety of Eurartesim® in patients with Imported Uncomplicated Plasmodium
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.0 个研究点目标入组 100 人开始时间: 2013年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Have read the Information for the Patient and signed the Informed Consent Form;
- •2.Aged =18 years;
- •3.Ability to swallow oral medication;
- •4.Body weight comprised between 24 kg and 100 kg (included) for males and females;
- •5.Uncomplicated malaria with microscopically confirmed monoinfection by Plasmodium vivax or mixed infection (i.e. infection with P. vivax and other Plasmodium species);
- •6.Willingness to comply with the study protocol and the study visit schedule.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Participation in any investigational drug study during the previous 30 days;
- •2.Antimalarial treatment with chloroquine and quinine within the previous 6 weeks, with piperaquine-based compounds or mefloquine or lumefantrine within the previous 3 months and with halofantrine within the previous 30 days prior to screening;
- •3.Known hypersensitivity to piperaquine and/or dihydroartemisinin;
- •4.P. vivax/Plasmodium species asexual stage parasitaemia = 5% RBCs (in cases of mixed infection);
- •5.Clinical and/or laboratory features of severe malaria according to WHO criteria (WHO 2010);
- •6.ECG abnormality that requires urgent management (i.e. clinically significant arrhythmias, AV block II and III degree etc.);
- •7.Family history of sudden death, or known congenital prolongation of the QT interval
- •8.Lengthening of QT interval on ECG: QTc (Fridericia’s correction) =450 ms for males and =470 ms for females;
- •9.Concomitant administration of any treatment which can induce a lengthening of QT interval (i.e. antihistamines, macrolides, etc.) and of any antimalarial drugs (for the full list of prohibited drugs refer to section 8.3);
- •10.Any contraindication to blood sampling (i.e. important haemorrhagic diathesis);
- •11.Presence of intercurrent illness or any condition (i.e. severe vomiting and dehydration) which in the judgement of the Investigator would place the patient at undue risk or interfere with the study results;
- •12.Hypoglycaemia (blood glucose levels < 2.2 mmol/L or < 40 mg/dL);
- •13.Splenectomy;
- •14.Pregnant or lactating women. During the study period (Day 0- Day 42), fertile women who are sexually active must use an adequate birth control method. They should utilize oral or patch contraceptives, contraceptive implant or depot injection or an intrauterine device from at least one month before screening and during the whole study period. In all the other cases they have to agree to remain inactive or use condoms with a spermicidal agent during the study period;
- •15.Presence of jaundice;
- •16.Known renal impairment (serum creatinine > 2X the upper limit of the hospital laboratory reference range);
- •17.Known liver insufficiency (AST and/or ALT > 3X the upper limit of the hospital laboratory reference range);
- •18.Relevant anaemia (Hb< 8 g/dL).
研究者
相似试验
进行中（未招募）
1 期
Evaluation of efficacy and safety of Eurartesim® in patients with imported uncomplicated Plasmodium Vivax Malaria, contracted in endemic countries.Patients affected by uncomplicated Plasmodium vivax malariaMedDRA version: 17.0 Level: PT Classification code 10035503 Term: Plasmodium vivax infection System Organ Class: 10021881 - Infections and infestationsEUCTR2013-003763-56-DESigma-Tau Industrie Farmaceutiche Riunite S.p.A.100
进行中（未招募）
1 期
Evaluation of efficacy and safety of Eurartesim® in patients with imported uncomplicated Plasmodium Vivax Malaria, contracted in endemic countries.Patients affected by uncomplicated Plasmodium vivax malariaMedDRA version: 16.1Level: PTClassification code 10035503Term: Plasmodium vivax infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2013-003763-56-ESSigma-Tau Industrie Farmaceutiche Riunite S.p.A.27
撤回
2 期
Proof of Concept Study of Eurartesim® in Patients with Imported Uncomplicated Plasmodium Vivax Malaria10037072MalariaNL-OMON40593Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.10
进行中（未招募）
1 期
Evaluation of efficacy and safety of Eurartesim® in patients with imported uncomplicated Plasmodium Vivax Malaria, contracted in endemic countries.Patients affected by uncomplicated Plasmodium vivax malariaMedDRA version: 16.1Level: PTClassification code 10035503Term: Plasmodium vivax infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2013-003763-56-NLSigma-Tau Industrie Farmaceutiche Riunite S.p.A.27
已完成
1 期
Safety Study on the Effect of Eurartesim™ on QT/QTc Interval Compared to Riamet in Healthy VolunteersMalaria, FalciparumNCT01103830sigma-tau i.f.r. S.p.A.287