A Phase 4, Observational Field Study to Evaluate TPOXX in... | NCT03972111

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

NCT03972111

Sponsor

SIGA Technologies

Status

Withdrawn

Last Update Posted

Oct 3, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Smallpox

Interventions

TPOXX 200Mg Capsule

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

commitment fulfilled

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Sep 30, 2024Estimated

First Submitted Date

May 30, 2019

First Submission Date that Met QC Criteria

May 31, 2019

First Posted Date

Jun 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2022

Last Update Posted Date

Oct 3, 2022Actual

Name	Class
Biomedical Advanced Research and Development Authority	FED

Description Module

Brief 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
TPOXX 200Mg Capsule	Drug	TPOXX 600 mg (three 200 mg.) capsules twice daily for 14 days		tecovirimat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess survival	To assess the overall survival at Day 44 following treatment with TPOXX	44 days post first dose of TPOXX

Secondary Outcomes

Measure	Description	Time Frame
Survival status	Survival status after completion of 14 days of TPOXX treatment will be assessed by physician for inpatients and collected from patient via patient diary question or follow up telephone contact.	14 days post first dose of TPOXX
Time to death

Other Outcomes

Measure	Description	Time Frame
Exploratory objective-TPOXX plasma concentration	To evaluate the plasma concentration of TPOXX from any available samples	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.

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

ID	Term
D011213	Poxviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections