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| Overall Recruitment Status: Active, currently enrolling |
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| Official Title |
| Expanded Access IND Protocol: Use of Tecovirimat (TPOXX) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children |
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Sponsors |
| Colorado |
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| Acronym |
NCT No. |
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NCT00000000 |
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| Study Type |
Phase |
| INTERVENTIONAL |
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| Purpose |
| The purpose of this expanded access IND (compassionate use) program is to provide stockpiled tecovirimat for treatment of non-variola orthopoxvirus infections (e.g., monkeypox, vaccinia, or other human virus infection identified as an orthopoxvirus) and secondary treatment of complications from replication-competent vaccinia vaccine in adults and children.
To monitor clinical use of tecovirimat, including any occurrence of serious adverse events, patient monitoring and outcomes information are also intended to be collected under this expanded access IND program to the extent feasible (e.g., baseline clinical conditions, progression/improvement post treatment, recovered or not recovered from orthopoxvirus infection).
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| Detailed Description |
| Background
Currently, there is no treatment approved by the Food and Drug Administration (FDA) for non-variola orthopoxvirus, including MPX. Although tecovirimat is FDA-approved for treatment of smallpox in adults and children, the approved indication is limited to smallpox. Therefore, this intermediate-size patient population expanded access Investigational New Drug (IND), sponsored by the Centers for Disease Control and Prevention (CDC) and authorized by FDA, is to allow access to and use of stockpiled tecovirimat for treatment of non-variola orthopoxvirus (NV-OPXV) infection in adults and children.
While the effectiveness of tecovirimat in treating human non-variola orthopoxvirus infections, including monkeypox, has not been evaluated, it may be reasonable to anticipate potential treatment benefit based
on animal efficacy data that supported FDA-approval for smallpox treatment and limited clinical uses of tecovirimat in the treatment of NV-OPXV infected individuals to date.
Tecovirimat has been shown to be effective against various orthopoxviruses in multiple animal challenge model. Tecovirimat was approved for smallpox under the FDA?s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.
Objectives
The purpose of this expanded access IND (compassionate use) program is to provide stockpiled tecovirimat for treatment of non-variola orthopoxvirus infections (e.g., monkeypox, vaccinia, or other human virus infection identified as an orthopoxvirus) and secondary treatment of complications from replication-competent vaccinia vaccine in adults and children.
To monitor clinical use of tecovirimat, including any occurrence of serious adverse events, patient monitoring and outcomes information are also intended to be collected under this expanded access IND program to the extent feasible (e.g., baseline clinical conditions, progression/improvement post treatment, recovered or not recovered from orthopoxvirus infection).
On animal efficacy data that supported FDA-approval for smallpox treatment and limited clinical uses of tecovirimat in the treatment of NV-OPXV infected individuals to date.
Tecovirimat has been shown to be effective against various orthopoxviruses in multiple animal challenge model. Tecovirimat was approved for smallpox under the FDA?s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.
Objectives
The purpose of this expanded access IND (compassionate use) program is to provide stockpiled tecovirimat for treatment of non-variola orthopoxvirus infections (e.g., monkeypox, vaccinia, or other human virus infection identified as an orthopoxvirus) and secondary treatment of complications from replication-competent vaccinia vaccine in adults and children.
To monitor clinical use of tecovirimat, including any occurrence of serious adverse events, patient monitoring and outcomes information are also intended to be collected under this expanded access IND program to the extent feasible (e.g., baseline clinical conditions, progression/improvement post treatment, recovered or not recovered from orthopoxvirus infection).
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- Please contact Study team for inclusion information.
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- Please contact Study team for exclusion information.
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