A multicenter, open-label, double-arm trial to evaluate the efficacy and safety of oral tecovirimat therapy for patients with mpox or smallpox.

Phase 2

Recruiting

• Conditions: Mpox, Smallpox

• Registration Number: JPRN-jRCTs031220169
• Lead Sponsor: Morioka Shinichiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-28
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) Patients who can provide written consent for participation in the study.
2) Male or female patients whose weight is 13kg or more.
3)Patients who are diagnosed with mpox or smallpox.However, smallpox is diagnosed when the pathogen is detected in a blister, pustule, crust,pharyngeal swab, or blood specimen, etc., and Mpox is diagnosed when the pathogen is detected in a skin or mucosal lesion, blister contents, nasopharyngeal swab, pharyngeal swab, anorectal swab, other mucosal swab, blood, urine, or other materials suitable for the test method, by the following methods. The diagnosis is made when pathogens are detected in pharyngeal swab fluid, anorectal swab fluid, other mucous membrane swab fluid, blood, urine, or other materials suitable for the test metho
d by the following methods
-Direct observation of virus particles by electron microscopy
-Detection of pathogens by isolation and identification
-Detection of pathogen antigens by fluorescent antibody method
-Detection of pathogen genes by PCR method
4)Patients who agree to be hospitalised until the first Tecovirimat course of oral treatment is completed, if oral
Tecovirimat is administerd.
5) Patients with severe mpox or mpox with high risk of severe disease
All of 1)-3) must be met. As for mpox patients, 4) and 5) also must be met.

Exclusion Criteria

1) Patients who have experienced any anaphylactic reaction to oral Tecovirimat or its ingredients.
2)Patients whom the study doctor considered to be ineligible.

Note 1) breast-feeding females will be counseled that tecovirimat has not been studied in breast-feeding women and may opt to cease breast-feedingfor the duration of the treatment and at least 30 days after the last dose of drug and thus be eligible for the treatment arm. Women who choose to continue breast-feeding will not be enrolled in the treatment arm.

Note 2) Although reproductive toxicity has not been adequately evaluated in animal studies, no cle
ar reproductive toxicity has been demonstrated to date. However, due to the lack of actual experience with administration to pregnant human women, the drug's package insert states that administration of Tecovilimat during pregnancy is not recommended. However, because there are no other candidates for effective treatment against mpox or smallpox, and because mpox can be transmitted transplacental to the fetus, causing miscarriage, premature delivery, or stillbirth, pregnant individuals should be fully aware of the above advantages and disadvantages of tecovirimat administration before they are eligible to participate as a dosing group The pregnant woman must fully understand the advantages and disadvantages of Tecovilimat administration described above to be eligible to participate in the study.

Note 3) In the case that a patient in the non-treatment arm wishes to join the treatment arm, the patient will be allowed to do so if the study doctor judges appropriate, after withdrawing the consent and providing another written consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified