CLINICAL TRIALS PROFILE FOR ANTIVENIN
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All Clinical Trials for ANTIVENIN
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00657540 ↗ | Black Widow Spider Antivenin for Patients With Systemic Latrodectism | Completed | Rare Disease Therapeutics Inc. | Phase 3 | 2009-10-01 | The purpose of this study is to test the efficacy and safety of a new antivenom called Analatro® for treating black widow spider bites in patients who present to a hospital emergency room within 24 hours of symptom onset. This study will be a phase III, multi-center, double-blind, randomized controlled study that takes place in emergency departments. The primary aim of this study is to determine the proportion of patients in which pain control was not achieved by 48 hours post treatment. Secondary aims are as follows: 1) a reduction in pain intensity at the end of the treatment phase compared to baseline; 2) the proportion of patients with a clinically significant decrease in pain intensity at 30 minutes post-treatment; 3) the proportion of patients in which drug-related adverse events occurred; and 4) to determine if serious, drug-related adverse events in Analatro-treated patients occurred at a rate greater than one in 10 (10%). |
| NCT00657540 ↗ | Black Widow Spider Antivenin for Patients With Systemic Latrodectism | Completed | Instituto Bioclon S.A. de C.V. | Phase 3 | 2009-10-01 | The purpose of this study is to test the efficacy and safety of a new antivenom called Analatro® for treating black widow spider bites in patients who present to a hospital emergency room within 24 hours of symptom onset. This study will be a phase III, multi-center, double-blind, randomized controlled study that takes place in emergency departments. The primary aim of this study is to determine the proportion of patients in which pain control was not achieved by 48 hours post treatment. Secondary aims are as follows: 1) a reduction in pain intensity at the end of the treatment phase compared to baseline; 2) the proportion of patients with a clinically significant decrease in pain intensity at 30 minutes post-treatment; 3) the proportion of patients in which drug-related adverse events occurred; and 4) to determine if serious, drug-related adverse events in Analatro-treated patients occurred at a rate greater than one in 10 (10%). |
| NCT04848714 ↗ | Pharmacokinetic Study Protocol of ANAWIDOW Lyophilized Powder for Solution for Intravenous Use in Fasting Conditions | Active, not recruiting | Rare Disease Therapeutics Inc. | Phase 1 | 2021-07-01 | A single-dose, open-label, single-treatment, single-period pharmacokinetic study under fasting conditions, in 12 healthy adult. To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for intravenous use. |
| NCT04848714 ↗ | Pharmacokinetic Study Protocol of ANAWIDOW Lyophilized Powder for Solution for Intravenous Use in Fasting Conditions | Active, not recruiting | Laboratorios Silanes S.A. de C.V. | Phase 1 | 2021-07-01 | A single-dose, open-label, single-treatment, single-period pharmacokinetic study under fasting conditions, in 12 healthy adult. To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for intravenous use. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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