NL-OMON47227
已完成
不适用
Repeated Controlled Human Hookworm Infection in Healthy Dutch Volunteers - ReCHHI1
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Hookworm infection
- 发起方
- eids Universitair Medisch Centrum
- 入组人数
- 24
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Subject is aged \* 18 and \* 45 years and in good health.
- •2\. Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- •3\. Subject is able to communicate well with the investigator, is available to attend all study visits.
- •4\. Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period.
- •5\. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
- •6\. Subject has signed informed consent.
排除标准
- •1\. Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immune\-deficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following:
- •\* Body Mass Index (BMI) \<18\.0 or \>35\.0 kg/m2 at screening;
- •\* positive HIV, HBV or HCV screening tests;
- •\* the use of immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti\-histamines exempted) or expected use of such during the study period;
- •\* Having one of the following laboratory abnormalities: ferritine \<10ug/L, transferrine \<2\.04g/L or Hb \<7\.0 mmol/L for females or \<8\.0 mmol/L for males.
- •\* history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years;
- •\* any history of treatment for severe psychiatric disease by a psychiatrist in the past year;
- •\* history of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.
- •2\. Known hypersensitivity to or contra\-indications for use of albendazole. Including co\-medication known to interact with albendazole metabolism (e.g. carbamazepine, phenobarbital, phenytoin, cimetidine, theophylline, dexamethasone)
- •3\. Known allergy to amphotericin B or gentamicin.
结局指标
主要结局
未指定
相似试验
招募中
不适用
Maintaining Controlled Human Hookworm Infection Model studies at Leiden University Medical CenterNL-OMON55129eids Universitair Medisch Centrum4
尚未招募
不适用
Maintaining Controlled Human Hookworm Infection Model studies at Leiden University Medical CentrehookwormNL-OMON24634MC (Prof. M. Yazdanbakhsh)4
招募中
不适用
Establishing a Controlled Human Hookworm Infection Model at Leiden University Medical CenterNL-OMON42940eids Universitair Medisch Centrum4
已完成
不适用
Therapeutic Hookworm Phenotyping Studyautoimmune diseasesallergic diseasesInflammatory and Immune System - Autoimmune diseasesAlternative and Complementary Medicine - Other alternative and complementary medicineACTRN12619001129178Malaghan Institute of Medical Research18
已完成
不适用
Repeated Controlled Human Hookworm InfectionNecator Americanus InfectionNCT03257072Meta Roestenberg24