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Treatment Protocol for Use of Anascorp™ in Patients With Scorpion Sting Envenomation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00624078
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : February 23, 2011
Sponsor:
Collaborator:
University of Arizona
Information provided by:
Instituto Bioclon S.A. de C.V.

Tracking Information
First Submitted Date  ICMJE December 26, 2007
First Posted Date  ICMJE February 26, 2008
Last Update Posted Date February 23, 2011
Study Start Date  ICMJE May 2005
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
Evaluate the adverse events profile of each patient [ Time Frame: immediately after treatment, 24 hrs and 14 days. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
Resolution of systemic signs of scorpion envenomation [ Time Frame: after treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment Protocol for Use of Anascorp™ in Patients With Scorpion Sting Envenomation
Official Title  ICMJE Treatment Protocol for Use of Anascorp™ in Patients With Scorpion Sting Envenomation
Brief Summary

This treatment protocol will enable therapeutic use of Anascorp in the management of systemic manifestations of scorpion sting envenomation, in patients for whom antivenom would otherwise be unavailable. The working hypotheses are as follows:

  1. The investigational antivenom is safe as treatment of scorpion sting envenomation.
  2. The investigational antivenom is effective as treatment of scorpion sting envenomation.
Detailed Description

The purpose of this Open Label, Multi-Center Treatment Protocol, phase III trial is to examine the safety and efficacy of Anascorp, for treatment of patients envenomed by scorpion sting.

The treatment protocol, including up to 25 Arizona sites, increases the total number of subjects receiving Anascorp™, and can provide supplemental safety data for the review process. At the same time, it will prevent a public health crisis in rural Arizona by replacing the dwindling supply of local antivenom before an BLA is approved.

Patients who arrive at the emergency clinic presenting with scorpion sting symptoms will be evaluated for treatment with Anascorp.

Each patient who qualifies for entry into the study, according to inclusion/exclusion criteria, is assigned a patient number in sequential order of entry. Approximately 100 patients could be enrolled in the study per year.

After informed consent has been obtained, a baseline history and physical will be obtained and documented in the patient's chart. This will include an evaluation of the symptoms of systemic scorpion envenomation. The patient's vital signs (blood pressure, pulse and respiration) will be taken. The patient will be questioned as to concomitant medications. Demographic data will also be collected.

Three vials of Anascorp will be administered in a total volume of 50 mL, intravenous over not less than 10 minutes or as permitted by IV access. If clinically indicated by systemic signs, a second dose (one vial) will be administered if clinically indicated by systemic signs. One additional dose may be administered 30 minutes later if indicated by clinically significant signs of envenomation. When clinically significant signs have been absent for at least 30 minutes, a final physical assessment will take place and the patient will be discharged to home.

Twenty four hours and fourteen days after Anascorp™ treatment, all patients will be monitored for signs and symptoms of adverse events, including acute hypersensitivity reactions (anaphylactic and/or anaphylactoid reactions) and delayed serum sickness. All patients who received study drug will be included in the final analyses.

For the individual patient, the study starts at the time the consent is signed and ends at the 14 day telephone interview. The outcome is assessed 14 days after discharge by telephone interview.

Concomitant therapy and medications may be used at any time as needed. All concomitant medication must be documented in the CRF from time of entry into the study until the 14 day follow up telephone interview..

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Scorpion Sting Envenomation
Intervention  ICMJE Drug: Antivenin Centruroides (scorpion) F(ab)2 Anascorp™
three vials diluted in 20 to 50 mL normal saline administered intravenously. Subsequent single vial doses of Anascorp, up to a total of five vials administered at thirty minutes intervals until resolution of symptoms.
Study Arms  ICMJE Experimental: 1
Patients who arrive to emergency room with scorpion sting envenomation will be evaluated according to inclusion/exclusion criteria. After informed consent has been signed they will be assigned to unique treatment arm with Anascorp.
Intervention: Drug: Antivenin Centruroides (scorpion) F(ab)2 Anascorp™
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2011)
1426
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2008)
600
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females of any age presenting for emergency treatment with clinically important systemic signs of scorpion sting envenomation
  • Signed written Informed Consent by patient or legal guardian

Exclusion Criteria:

  • Allergy to horse serum
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00624078
Other Study ID Numbers  ICMJE AL-03/07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Walter Garcia U. MD/Clinical Research Manager, Instituto Bioclon
Study Sponsor  ICMJE Instituto Bioclon S.A. de C.V.
Collaborators  ICMJE University of Arizona
Investigators  ICMJE
Principal Investigator: Leslie Boyer, M.D VIPER Institute
Study Chair: Walter Garcia, M.D Instituto Bioclon S.A. de C.V.
PRS Account Instituto Bioclon S.A. de C.V.
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP