Phase II b Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment.
研究概览
简要总结
Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There are currently no drugs that are easily administered and have low toxicity, and might thus be used as tools to support disease control.
This study aims to compare the safety and efficacy of DB289, a new, orally administered dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of several partners from academia, industry and from the Democratic Republic of Congo Ministries of Health.
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has early stage T. b. gambiense infection i.e. parasitologically confirmed infection in the blood or lymph node aspirate and greater than or equal to 5 WBC mm-3 detected in the CSF by microscopic examination
- •Patient is 15 to 50 years old
- •Patient has a minimal weight of 35 kilograms
- •If the patient is female of child bearing potential (a women will be considered of non-child bearing potential only if she has been post menopausal for over 2 years or has had a hysterectomy):
- •she is not lactating,
- •she had a negative urine pregnancy test result within 24 hours prior to DB289 treatment and
- •she agrees to use a medically proven method of contraception (abstinence from sexual intercourse is an acceptable method) from the day of consent on until the end of the observation period (day 7).
- •Patient has understood and signed the Informed Consent. If the patient is minor, a legal guardian has signed the Informed Consent
排除标准
- •The patient has late stage T.b. gambiense infection i.e. presence of parasite in the CSF upon microscopic examination or a WBC count of > 5mm-1
- •Active clinically relevant medical conditions that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to: significant liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, infection including known HIV infection, CNS trauma or seizure disorders (A list of typical signs and symptoms is provided for guidance of the investigator in attachment 1)
- •Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8)
- •Withdrawal of consent at any time during the study
- •Any condition which compromises ability to communicate with the investigator as required for the completion of this study.
- •The subject has been previously treated for African Trypanosomiasis.
- •The subject has been previously enrolled in the study. -
研究组 & 干预措施
DB289
Pafuramidine maleate (DB289), 100 mg BID orally
干预措施: DB289 (Drug)
Pentamidine
Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM
干预措施: Pentamidine (Drug)
结局指标
主要结局
The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment.
时间窗: 3 months
The primary outcome measure for safety analysis was the rate of occurrence of Grade 3 or higher adverse events during the observation period.
时间窗: 12 day
次要结局
- The secondary outcome measure was the incidence rate of adverse events (all Grades combined) during the 7- to 9-day observation period in Treatment Sequence 1 and during the 12-day observation period in Treatment Sequence 2.(12 day)
- The number and percentage of subjects with parasitological cure, subjects with confirmed (parasitological) treatment failure, and subjects with suspected treatment failure at 6, 12, and 24 months after completion of treatment.(6, 12, 24 months)