At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 449 enrolled
Drug / intervention
tecovirimat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects
In Brief
A Phase 3 clinical trial evaluating tecovirimat and Placebo for Smallpox. Completed, enrolled 449 participants across 11 sites.
Detailed Summary
Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmallpox
CountriesUnited States
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJun 2015
Primary CompletionAug 2016
TodayJul 2026
First PostedJun 18, 2015
Enrollment StartJun 19, 2015
Primary CompletionAug 24, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.0 years ago
Interventions
tecovirimatdrug
Study is based on Animal Regulatory Rule
Placeboother
Does not apply