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Optimal Dose of Antivenom for Daboia Siamensis Envenomings

NCT04210141 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-04-01

No results posted yet for this study

Summary

The aim of the study is to identify an 'optimal' initial dosing of the new Burma Pharmaceutical Industry (BPI) lyophilized mono-specific antivenom for patients with systemic Daboia siamensis envenoming. The initial dosing will aim to reverse venom-induced coagulopathy (as demonstrated by a negative 20 minutes Whole Blood Clotting Time (20WBCT) at 6 hours in 95% of patients whilst causing less than 5% anaphylactic reaction.

Conditions

  • Daboia Siamensis Envenoming

Interventions

BIOLOGICAL

lyophilized BPI viper antivenom

Antivenom

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

  • Myanmar Oxford Clinical Research Unit

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2027-02-01
Completion
2027-11-01

Countries

  • Burma

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04210141 on ClinicalTrials.gov