Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-31 @ 1:00 PM
Study NCT ID:
NCT06615960
Status:
RECRUITING
Last Update Posted:
2024-09-27
First Post:
2024-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of PANAF-Premium TM Snake Venom Antiserum As Standard Treatment for Snakebites
Sponsor:
Premium Serums & Vaccines Pvt.Ltd.
Organization:
Study Overview
Official Title:
The Safety and Effectiveness of PANAF- Premium TM Snake Venom Antiserum-Pan Africa Administered As a Standard Treatment for Cases of Snakebites- a Phase IV Open Label Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMS
Brief Summary:
Snakebite envenomation (SBE) is a major public health problem in many developing countries. Standard snake antivenom (SA) remains the primary treatment and has been shown to reduce mortality in observational studies conducted in several sub-Saharan African (SSA) countries. Although it is relatively available in other endemic contexts such as Asia and Latin America, there have been major challenges with the reliable supply of effective products in sub-Saharan Africa for many years. Premium Serums \& Vaccines Pvt. Ltd. (PSVPL) recently introduced its SA brand, namely PANAF-Premium TM, manufactured to address unmet treatment needs in the local context. This serum has received WHO approval for use in sub-Saharan Africa and is used in Cameroon with neutralizing efficacy for 24 species represented in Africa.
This is an open-label, Phase IV post-marketing surveillance study to collect safety and effectiveness data systematically following the administration of PANAF-Premium TM. The study will describe the types, severity, and number of adverse events recorded following the administration of PANAF-Premium TM and its effectiveness for snakebite management. Epidemiological data will also be collected, along with information on the snake species typically responsible for bites in the North region of Cameroon, the type of envenomation, the total dose of SA required for reversal of envenomation, and the total time required for clinical recovery. This will complement the international and national pool of pharmacovigilance data.
This is an open-label, Phase IV post-marketing surveillance study to collect safety and effectiveness data systematically following the administration of PANAF-Premium TM. The study will describe the types, severity, and number of adverse events recorded following the administration of PANAF-Premium TM and its effectiveness for snakebite management. Epidemiological data will also be collected, along with information on the snake species typically responsible for bites in the North region of Cameroon, the type of envenomation, the total dose of SA required for reversal of envenomation, and the total time required for clinical recovery. This will complement the international and national pool of pharmacovigilance data.
Detailed Description:
Background: Snakebite envenomation (SBE) is a major public health problem in many developing countries. Conventional snake antivenom (SA) remains the primary treatment and has been shown to reduce mortality in observational studies conducted in several sub-Saharan African (SSA) countries. Although it is relatively available in other endemic contexts such as Asia and Latin America, there have been major challenges with the reliable supply of effective products in sub-Saharan Africa for many years. Premium Serums \& Vaccines Pvt. Ltd. (PSVPL) recently introduced its SA brand, namely PANAF-Premium TM, manufactured to the latest standards, providing a solution to address unmet treatment needs in the local context. This serum has received WHO approval for use in sub-Saharan Africa and is used in Cameroon with neutralizing efficacy for 24 species represented in Africa. Since antivenom is of animal origin, it can cause adverse reactions ranging from mild itching to fatal anaphylaxis; therefore, patients should be treated appropriately or given prophylactic premedication. Approximately 20% of cases may develop early (within a few hours) or late (five days or more) allergic reactions after administration of snake antivenom. This open-label, Phase IV post-marketing surveillance study aims to collect safety and effectiveness data systematically following administration of PANAF-Premium TM. The study will describe the types, severity, and number of adverse events recorded following administration of PANAF-Premium TM and its effectiveness for snakebite management. Additionally, epidemiological data will be collected regarding the snake species typically responsible for bites in the North Cameroon region, the type of envenomation, the total dose of SA required for reversal of envenomation, and the total time required for clinical recovery. This will also contribute to the international and national pool of pharmacovigilance data.
Method: An open-label, Phase IV post-marketing surveillance trial will be conducted to describe the types, severity, and number of adverse events recorded during snakebite management. The average dose of SA used will be identified, and the duration of recovery, as well as the type of snakes prevalent in the area, will be explored. Eligible patients will be admitted to the hospital, and case management will be in accordance with the standard protocol followed in Cameroon and adapted from the guidelines of the African Society of Venomology. Any medication or procedure necessary to save the patient will be permitted. If antivenom serum is needed, the study drug to be used is PANAF-Premium TM (Snake Venom Antiserum-Pan Africa), manufactured by Premium Serums \& Vaccines Pvt. Ltd. Any suspicious or unexpected serious adverse events (SAEs) will be recorded immediately and reported to the sponsor/ethics committee for further action. There will be no restrictions on the use of any concomitant medication or other interventions or investigations mandated by the patient\'s clinical condition.
Method: An open-label, Phase IV post-marketing surveillance trial will be conducted to describe the types, severity, and number of adverse events recorded during snakebite management. The average dose of SA used will be identified, and the duration of recovery, as well as the type of snakes prevalent in the area, will be explored. Eligible patients will be admitted to the hospital, and case management will be in accordance with the standard protocol followed in Cameroon and adapted from the guidelines of the African Society of Venomology. Any medication or procedure necessary to save the patient will be permitted. If antivenom serum is needed, the study drug to be used is PANAF-Premium TM (Snake Venom Antiserum-Pan Africa), manufactured by Premium Serums \& Vaccines Pvt. Ltd. Any suspicious or unexpected serious adverse events (SAEs) will be recorded immediately and reported to the sponsor/ethics committee for further action. There will be no restrictions on the use of any concomitant medication or other interventions or investigations mandated by the patient\'s clinical condition.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: