A Comparison of Crotalinae Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab,

NCT00868309 | Completed Phase 2 Results

• 1 other identifier: AN-03/02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II study was a prospective, randomized, open-label, multi-center study in the United States, involving patients from 18 to 70 years of age, comparing Anavip (Antivenin Crotalinae \[pit viper\] equine immune F(ab)2; Instituto Bioclon, Mexico City, Mexico) against CroFab (Protherics Inc., Nashville, Tennessee), the only currently approved product for treatment of Crotalinae (pit viper) envenomation in the US. The study was designed to evaluate the hypothesis that lasting correction of snakebite induced thrombocytopenia and hypofibrinogenemia are possible following correction with F(ab)2 antivenom, by analyzing in detail the relationships among platelet count, fibrinogen, venom levels, and antivenom levels in subjects presenting with thrombocytopenia following crotaline viper envenomation. In the study we expected to see a fall in platelet count following Fab treatment, commensurate with that reported in the past. We hypothesized that following F(ab)2 treatment there would be a slower drop in post-treatment platelet counts, with a relatively higher platelet count at any given point in the follow-up period. We further hypothesized that an initial rise and later fall in platelet count would correspond with rise and fall in antivenom levels, and would be mirrored by concurrent drop and rise in levels of unbound circulating venom.

Conditions

Snake Bite; Blood Coagulation Disorders

Keywords

Snake Bite; Venom and antivenom kinetics

Outcome Measures

Primary Outcomes (1)

• Detection of Plasma Venom Levels During the Post Acute Treatment Period.

  Follow up after Maintenance doses were completed. Two Weeks.

Secondary Outcomes (1)

• >50,000 Platelets/mm3

  Follow up after maintenance dose

Study Arms (2)

Anavip

EXPERIMENTAL

The initial dose of study drug was administered in a total volume of 500 mL (initial doses only) IV over 30 minutes for Anavip

Biological: Anavip

CroFab

ACTIVE COMPARATOR

The initial dose of study drug was administered in a total volume of 500 mL (initial doses only) IV over 60 minutes for CroFab, or as permitted by IV access.

Biological: CroFab

Interventions

Anavip BIOLOGICAL

Anavip, 10 vials Intravenous (IV) every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs

Also known as: Antivenin Crotalinae (pit viper) equine immune F(ab)2

Anavip

CroFab BIOLOGICAL

CroFab, 5 vials Intravenous (IV) every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs

CroFab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women 18 to 70 years of age
• presenting for emergency treatment of pit viper bite
• informed consent document read and signed by subject

You may not qualify if:

• allergy to horse serum, sheep serum, or papaya
• current use of any antivenom, or use within the last month
• current participation in a clinical drug study, or participation within the last month
• pregnancy or breast-feeding
• underlying medical conditions that significantly alter blood coagulation: thrombocytopenia, hemophilia, familial dysfibrinogenemia, leukemia, recent ingestion of superwarfarin compounds (rat poison)
• use of any medication expected to affect platelet count, coagulation factors, or fibrinogen: chemotherapeutic agents, warfarin, heparin, aspirin
• No clinical indications of snake bite envenomation

Sponsors & Collaborators

• Instituto Bioclon S.A. de C.V.: lead
• University of Arizona: collaborator

Study Sites (1)

Tucson snakebite investigational site

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Snake Bites; Blood Coagulation Disorders

Interventions

anavip; Crotalidae Polyvalent immune Fab

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Walter Garcia
• Organization: Instituto Bioclon S.A. de C.V.

wgarcia@silanes.com.mx

+52 (55)54883700

Study Officials

• Walter García, MD

  Instituto Bioclon

  STUDY DIRECTOR

• Leslie Boyer, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Alejandro Alagón, MD, PhD

  Instituto de Biotecnología UNAM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: March 24, 2009
• Study Start: January 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: February 1, 2007
• Last Updated: April 18, 2016
• Results First Posted: March 24, 2009

Record last verified: 2016-03

Locations

US (1)