NCT05380752No Longer Available不适用
EXPANDED ACCESS PROTOCOL FOR TREATMENT OF INDIVIDUALS FOLLOWING EXPOSURE TO ORTHOPOX VIRUSES WITH TPOXX IV (TECOVIRIMAT INJECTION, 10 mg/mL)
U.S. Army Medical Research and Development Command0 个研究点开始时间: 2022年5月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
研究概览
简要总结
- To provide a therapeutic option for patients not able to take the oral formulation of TPOXX (e.g., cannot swallow, vomiting) and who have confirmed or suspected (based on clinical signs and symptoms with known exposure while laboratory confirmation may be pending) orthopox virus infections OR who have a significant vaccinia adverse reaction (as defined in the protocol) resulting from vaccinia vaccination, secondary transmission, or other exposure;
- To collect data on the safety of TPOXX IV (tecovirimat injection, 10 mg/mL).
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed or suspected (based on clinical signs and symptoms with known or suspected exposure and/or positive or pending laboratory confirmation) orthopox virus infection.
- •Note: Patients with a negative orthopox virus diagnostic test but with epidemiological and clinical evidence of an orthopox viral infection, especially those with evidence of clinical disease progression, may be included. Primary/Treating physician may consult with sponsor's Subject Matter Expert; OR Have developed a significant vaccinia adverse reaction (e.g., eczema vaccinatum, progressive vaccinia, generalized vaccinia that is severe or persistent, and select cases of inadvertent inoculation due to severe pain related to mucosal involvement, ocular involvement) resulting from vaccination, secondary transmission, or other exposure;
- •Be DoD-affiliated personnel (including active and reserve component service members, US civilian employees, contractors, other US personnel, and dependents, as well as allied military forces and local nationals) who have been granted access to the medical facility;
- •Unable to take the oral formulation of TPOXX (e.g., unable to swallow capsules or take medication powder dissolved in soft food or liquid, vomiting);
- •Is available for clinical follow-up for duration of the treatment and follow-up period;
- •Females of childbearing potential must use a highly effective method of contraception during treatment and for 30 days after the last dose of drug. Male patients with a female partner of childbearing potential must use an acceptable method of contraception and refrain from donating sperm during treatment and for 30 days after the last dose.
排除标准
- •Hypersensitivity to tecovirimat;
- •Unable or unwilling to cooperate with the requirements of the protocol;
- •Breastfeeding women: Nursing mothers will be counseled that tecovirimat has not been studied in breast-feeding women. Women who choose to continue breastfeeding will not be enrolled in this protocol. However, if a patient elects to stop breastfeeding for the duration of the study until 30 days after the last dose of the TPOXX IV, she may be enrolled.
研究者
相似试验
Available
不适用
Expanded Access to TriheptanoinLong Chain Fatty Acid Oxidation DisordersNCT03773770Ultragenyx Pharmaceutical Inc
Unknown
不适用
Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular System InjuriesNCT03631056Humacyte, Inc.
已完成
不适用
An Expanded Access Open Label Protocol of Remune (HIV-1 Immunogen) in HIV-1-Infected Adults With CD4 Count 550 Cells /Ml and Greater.HIV InfectionsNCT00002173The Immune Response Corporation
已完成
3 期
An Extension Treatment Protocol for Subjects Who Have Participated in a Study of Tivozanib Versus Sorafenib in Kidney Carcinoma (Protocol AV-951-09-301).Advanced Renal Cell CarcinomaNCT01076010AVEO Pharmaceuticals, Inc.277
No Longer Available
不适用
Expanded Access for PSV Personalized Oncolytic VirusesCancerNCT03529539EpicentRx, Inc.