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

NCT03972111 | Withdrawn FDA Drug

• 1 other identifier: SIGA-246-021
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smallpox

Outcome Measures

Primary Outcomes (1)

• Assess survival

  To assess the overall survival at Day 44 following treatment with TPOXX

  44 days post first dose of TPOXX

Secondary Outcomes (2)

• Survival status

  14 days post first dose of TPOXX

• Time to death

  From date of treatment with TPOXX until the date of death from any cause, whichever came first, assessed up to 44 days after TPOXX treatment

Other Outcomes (1)

• Exploratory objective-TPOXX plasma concentration

  Plasma samples will be collected to determine the plasma concentration of TPOXX from Days 1-14 of the TPOXX treatment period for inpatients. This data will be reported.

Interventions

TPOXX 200Mg Capsule DRUG

TPOXX 600 mg (three 200 mg.) capsules twice daily for 14 days

Also known as: tecovirimat

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult and pediatric patients who weigh ≥13 kg who receive FDA-approved TPOXX as part of their medical treatment for variola virus (VARV) infection in the United States (US). These patients will have suspected, probable, or confirmed smallpox. The purpose of this field study is to evaluate the safety, survival status, time to death, and smallpox rash progression in patients who are receiving TPOXX for the treatment of smallpox in the US

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• SIGA Technologies: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

Investigator Site

Corvallis, Oregon, 97333, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

smallpox lesion samples and blood collected to assess viral DNA levels and conduct genotypic resistance analysis and phenotypic analysis if possible.

MeSH Terms

Conditions

Smallpox

Interventions

tecovirimat

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Dennis E. Hruby, PhD

  SIGA Technologies

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: January 1, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

US (1)