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WITHDRAWN

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

NCT03972111•SIGA Technologies

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Able to provide informed consent or assent themselves or through a guardian or legally authorized representative, receiving or initiating treatment with TPOXX, and willing and able to adhere to the recommended procedures in the protocol.
•Determined, per the clinical definition of smallpox, that the patient presenting with a case of acute, generalized vesicular/pustular rash meets Centers for Disease Control and Prevention (CDC) criteria of having confirmed, suspected, or probable smallpox and/or is at high or moderate risk for developing smallpox.
•The CDC in coordination with the Department of Health and Human Services/Assistant Secretary for Preparedness and Response (ASPR) has released TPOXX to the physician or designated health authorities for patient treatment, and the CDC has provided physician contact information to PPD, the contract research organization.

Exclusion Criteria

•Known allergy to tecovirimat and/or excipients of TPOXX.

Locations (1)

Investigator Site

Corvallis, Oregon, United States

Key Dates

Start Date

January 1, 2020

Primary Completion Date

September 30, 2024

Completion Date

September 30, 2024

Last Updated

October 3, 2022

Conditions

Smallpox

Interventions

TPOXX 200Mg Capsule

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa

Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS

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