Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip.

Completed · Phase 3 · Has a placebo group

Conditions studied: Snake Bite

In brief

The purpose of this study is to establish if F(ab)2 antivenom (Anavip) is safe for crotalinae envenomation. Confirm its effectiveness in preventing the occurrence of delayed coagulopathies and compare the safety and efficacy with Fab antivenom (CroFab) in patients with Crotalinae envenomation.

Key facts

Study ID

NCT00636116

Run by

Instituto Bioclon S.A. de C.V.

People needed

121

Starts

2008-05-01

Expected to finish

2012-01-01

Last updated by the study team

2012-01-10

Who can join

Age: 2 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women 2 to 80 years of age
• Presenting for emergency treatment of pit viper bite
• Informed consent document read and signed by patient (or parent/legal guardian)

You may not qualify if…

• Current use of any antivenom, or use within the last month
• Current participation in a clinical drug study, or participation within the last month
• Positive urine or blood pregnancy test at screening
• Breast-feeding
• Allergy to horse serum, sheep serum, or papaya
• Underlying medical conditions that significantly alter platelet count or fibrinogen; thrombocytopenia, hemophilia, familial dysfibrinogenemia, leukemia
• Use of any medication expected to affect platelet count, coagulation factors or fibrinogen: chemotherapeutic agents, warfarin, heparin
• No clinical indications of snake bite requiring antivenom for treatment

Where it is running

• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• Maricopa Integrated Health System — Phoenix, Arizona, United States
• Northwest Medical Center — Phoenix, Arizona, United States
• Tucson Medical Center — Tucson, Arizona, United States
• University Physicians Hospital — Tucson, Arizona, United States
• University Medical Center — Tucson, Arizona, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• University of California San Diego — San Diego, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Florida Poison Information Center — Jacksonsville, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• LSU Health Sciences Center, Lousiana Poison Control Center — Shreveport, Louisiana, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• The University of New Mexico Hospital — Albuquerque, New Mexico, United States
• Pitt County Memorial Hospital — Greenville, North Carolina, United States
• St. Joseph Regional Health Center — Bryan, Texas, United States
• West Texas Regional Poison Center at Thomason Hospital — El Paso, Texas, United States
• Scott and White Memorial Hospital — Temple, Texas, United States

Full record on ClinicalTrials.gov

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