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Trials / Withdrawn

WithdrawnNCT03972111

A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox

A Phase 4, Observational Field Study to Evaluate the Safety and Clinical Benefit of TPOXX (Tecovirimat)-Treated Patients Following Exposure to Variola Virus and Clinical Diagnosis of Smallpox Disease

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
SIGA Technologies · Industry
Sex
All
Age
Healthy volunteers
Not accepted

Summary

Phase 4, Observational Field Study in Patients Treated With TPOXX for Smallpox Disease

Detailed description

Phase 4, Observational Field Study to evaluate safety and clinical benefit of TPOXX (tecovirimat) in patients treated with TPOXX following exposure to variola virus and a clinical diagnosis of smallpox disease.

Conditions

Interventions

TypeNameDescription
DRUGTPOXX 200Mg CapsuleTPOXX 600 mg (three 200 mg.) capsules twice daily for 14 days

Timeline

Start date
2020-01-01
Primary completion
2024-09-30
Completion
2024-09-30
First posted
2019-06-03
Last updated
2022-10-03

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03972111. Inclusion in this directory is not an endorsement.

A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox (NCT03972111) · Clinical Trials Directory