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Trial record 2 of 5 for:
"Monkeypox"
Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure
Expanded access is currently available for this treatment.
Verified August 2016 by U.S. Army Medical Research and Materiel Command
Sponsor:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT02080767
First received: March 4, 2014
Last updated: November 10, 2016
Last verified: August 2016
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Purpose
The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses.
| Condition | Intervention |
|---|---|
| Smallpox Monkeypox | Drug: Tecovirimat |
| Study Type: | Expanded Access What is Expanded Access? |
| Official Title: | Clinical Protocol to Treat Individuals With Tecovirimat (ST-246) After Exposure to Orthopox Viruses |
Resource links provided by NLM:
Further study details as provided by U.S. Army Medical Research and Materiel Command:
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
Criteria
Inclusion Criteria:
- DoD-affiliated personnel (including US civilian employees, contractors and other US personnel and dependents, as well as allied military forces and local nationals) of any age, not breastfeeding
- Has been exposed to or infected with orthopox viruses (ie, variola (smallpox), vaccinia, monkeypox, or cowpox) OR Has developed serious complications from vaccinia vaccination (eg, 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
- Is available for clinical follow-up for duration of the treatment and follow-up period
- Must be able to swallow capsules
Exclusion Criteria:
- Has hypersensitivity to tecovirimat
- Unable or unwilling to cooperate with the requirements of the treatment protocol
- Breast-feeding patients. Note that breast-feeding females will be counseled that tecovirimat has not been studied in breast-feeding women and may opt to cease breast-feeding for the duration of the treatment and at least 30 days after the last dose of drug and thus be eligible for enrollment. Women who choose to continue breast-feeding will not be enrolled in this treatment protocol.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02080767
Please refer to this study by its ClinicalTrials.gov identifier: NCT02080767
Contacts
| Contact: Frances K Devlin | 301-619-9904 | frances.k.devlin.ctr@mail.mil | |
| Contact: James W Karaszkiewicz, PhD | 301-619-6809 | James.W.Karaszkiewicz.ctr@mail.mil |
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
More Information
| Responsible Party: | U.S. Army Medical Research and Materiel Command |
| ClinicalTrials.gov Identifier: | NCT02080767 History of Changes |
| Other Study ID Numbers: |
M-10331 S-11-10 ( Other Identifier: Sponsor ) |
| Study First Received: | March 4, 2014 |
| Last Updated: | November 10, 2016 |
Additional relevant MeSH terms:
|
Smallpox Monkeypox Poxviridae Infections DNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on July 14, 2017