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Antiviral

ABCDE for Smallpox

Phase 4
Waitlist Available
Research Sponsored by SIGA Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 38 days
Awards & highlights

Study Summary

This trial looks at how well TPOXX works when taken with phosphate binders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~38 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 38 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma PK Parameter for TPOXX
Secondary outcome measures
Safety of 600 mg oral TPOXX administered with 4 different phosphate binders

Trial Design

4Treatment groups
Experimental Treatment
Group I: AEDCBExperimental Treatment1 Intervention
Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg coadministered with a single oral dose of 500 mg lanthanum carbonate chewable tablet. Single oral dose of TPOXX 600 mg coadministered with a single oral dose of 1334 mg calcium acetate Single oral dose of TPOXX 600 mg coadministered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet Single oral dose of TPOXX 600 mg coadministered with single oral dose of 1600 mg sevelamer carbonate
Group II: ADBECExperimental Treatment1 Intervention
Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet
Group III: ACEBDExperimental Treatment1 Intervention
Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate
Group IV: ABCDEExperimental Treatment1 Intervention
Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TPOXX
2022
Completed Phase 4
~520

Find a Location

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED
80 Previous Clinical Trials
909,351 Total Patients Enrolled
4 Trials studying Smallpox
1,612 Patients Enrolled for Smallpox
PPDIndustry Sponsor
159 Previous Clinical Trials
36,871 Total Patients Enrolled
1 Trials studying Smallpox
34 Patients Enrolled for Smallpox
SIGA TechnologiesLead Sponsor
10 Previous Clinical Trials
1,729 Total Patients Enrolled
6 Trials studying Smallpox
1,062 Patients Enrolled for Smallpox

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can partake in this research project?

"This clinical trial is looking for 44 individuals with smallpox aged between 18 and 50 who meet the following criteria: Phosphorus levels should be within standard laboratory reference ranges, either the subject or their partner has undergone sterilization surgery, must have gone 12 consecutive months without menstruation due to natural causes and a documented plasma follicle-stimulating hormone level of over 40 IU/mL."

Answered by AI

For what ailments is this remedy typically prescribed?

"This experimental intervention has been successfully applied to manage variola major (smallpox), hemodialysis, and astringent."

Answered by AI

What is the participant count of this medical experiment?

"This trial is presently inactive, as the last modification made to its posting was on October 6th 2022. However, there are 3 trials for smallpox and 9 clinical trials recruiting patients for this specific treatment that you could explore instead."

Answered by AI

How can patients be assured of their safety with this therapy?

"The established safety of this approved treatment earns it a score of 3 on our team's scale. This is because the trial has progressed to Phase 4, meaning there is considerable evidence demonstrating its efficacy and safety."

Answered by AI

Does this trial have any age restrictions on its participant pool?

"This clinical trial has an age restriction of between 18 to 50. For those younger than 18, there are 2 studies available and for people above 65, 7 trials can be found."

Answered by AI

Has this treatment been tested in any other research studies?

"Presently, there are 9 active trials researching this particular intervention - 4 of which have reached Phase 3. Although the bulk of these medical studies take place in Austin, Texas, 38 different sites across the country are conducting clinical research related to it."

Answered by AI

Are there any openings in this research program for participants?

"Contrary to what is listed on clinicaltrials.gov, this investigation has closed its enrollment period and is no longer recruiting participants. Initially posted on June 8th 2022, the trial was last modified October 6th 2022; however, there are 12 other trials presently seeking out patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders
2022. "Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04485039.
~16 spots leftby Apr 2025
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