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Snake BitePhase 4NCT00639951

Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation

A Phase 4 study testing A and Antivipmyn ® in people with Snake Bite, run by Instituto Bioclon S.A. de C.V. at 5 sites in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to compare whether a same total dose given up front as a single dose is more effective and as safe as the same dose given as a fractioned dose. Evaluate the Utility of the the Dry Tube Test Evaluating its Correlation with Coagulation Test Results (fibrinogen, platelets, INR, PT and PTT). Read more about this study

Who is it for?
Ages 6 to 65 years
Conditions the study is for
Snake Bite
What is being tested?
A and Antivipmyn ®
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
5 sitesMexico
Study dates
Jan 2008to Mar 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Men and women 6 to 65 years of age
  • Presenting for emergency treatment of snake bite
  • Requiring treatment with antivenom
  • Informed consent document read and signed by patient (or parent/legal guardian)
  • Participation within the last month on any clinical trial
  • Arrival to Hospital within 24 hours after the snake bite

Who cannot join

  • Allergy to horse serum
  • Underlying medical conditions that significantly alter coagulation (oral anticoagulants, vitamin K deficiency, hepatic disease)
  • Use of AINE 48 hours previously
  • Use of any antivenom 2 weeks previously
  • Pregnancy or breast-feeding women

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Mexico5 sites

  • Ciudad Valles Site

    Ciudad Valles, San Luis Potosí

  • Hospital Universitario de la UANL "Dr. José Eleuterio González"

    Monterrey, Nuevo León, 64460

  • Hermosillo Site

    Sonora, Hermosillo

  • Tempoal Site

    Tempoal de Sánchez, Veracruz, 92061

  • Nayarit Site

    Tepic, Nayarit, 63000

Other trials in Mexico

About this study

Official title: Multicentric, Randomized,Controlled and Comparative Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation

The purpose of this study is to compare whether a same total dose given up front as a single dose is more effective and as safe as the same dose given as a fractioned dose.

Evaluate the Utility of the the Dry Tube Test Evaluating its Correlation with Coagulation Test Results (fibrinogen, platelets, INR, PT and PTT).

Explore the Evolution of some Serum Markers (CK, DHL, metalloproteinase), Amount of Venom and Antivenom Levels and the Progression of Local Lesions.

Read the detailed description

Snake bite Envenomation is a Public Health Problem especially for tropical and subtropical countries. The WHO estimates 40 000 annual deaths in the world for this cause. In México the Ministry of Health estimated 3 882 cases on 2005, being the age of 15-44 the most affected. There are not official numbers of mortality, although the thought is that there are few cases of death, most of them related with a delay on treatment.

There are a broad variety of clinical presentations depending on many factors such as species, snake bite variability or patient conditions. Proteolytic action of venom produces amines and vasoactive peptides such as bradykinin, histamine and serotonin which cause capillary lesions with anticoagulant effects. Coagulopathy is one of the most important systemic consequences. The Dry Tube Test has been proposed as an indirect test to evaluate coagulopathy related to this pathology.

Conditions
Snake Bite
Being tested
A, Antivipmyn ®
Keywords
Snake Bite, Antivenin Treatment
Medical subject headings
Snake Bites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABiological

    Also called Crotalinae (pit viper) equine immune F(ab)2

    20 vials up front in a Single Dose of Antivipmyn

  • Antivipmyn ®Biological

    Also called Crotalinae (pit viper) equine immune F(ab)2

    20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®

Study groups in NCT00639951
Study groupRoleWhat they receive
A Normal dose GroupActive comparator20 vials up front in a Single Dose of Antivipmyn in 500 ml of solution IV, administered in 60 minutes. After 12 hours, it has to be perfomed a clinical evaluation of the patient. Each patient is going to have clinical studies of coagulation time and also the fibrinogen measures, this at 2, 4, 6, 8, 10, 12, 48, 72, 96 hours.All patients who have received at least one dose of medication study will be contacted by telephone to investigate the presence of symptoms suggestive of continuing with effect snake venom, or the presence of an adverse event, or any signs or symptoms indicating the presence of a hypersensitivity response to Antivipmyn® including serum sickness. If symptoms suggestive of an adverse event were discovered, the patient will referred for appropriate treatment.
Receives: Biological: A
B Placebo GroupPlacebo comparator20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®. The treatment schedule for each subject is a dose of 5 vials Antivipmyn® every 2 hours to complete 20 vials, the total duration is 6 hours of the treatment. Each dose IV shall apply in physiological solution 250ml, and finish its application in 15 minutes. For pediatric patients the volume administered should not exceed the recommended fluid volume according to your body weight. After the assessment at 12 hours, it can be administered at the discretion of more antivenom attending by the physician.
Receives: Biological: Antivipmyn ®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resolution of systemic signs and symptoms of snake bite envenomation expressed as % of patients requiring additional antivenom and % of patients that are stable

    Measured: 12 hours after initial treatment

Secondary outcomes (3)

  1. Evaluate the correlation between Dry Tube Test and Coagulation Test (PT, INR, PTT, platelets and fibrinogen)

    Measured: baseline, 2,4,6 hours and after each extra dose of Antivenom

  2. Evaluate Venom and Antivenom Levels with the other parameters

    Measured: baseline, 2 hours after initial treatment and after each extra dose of Antivenom

  3. Evaluate the possible relation of the serum markers (LDH, CPK, metalloproteinases)and local damage evolution.

    Measured: baseline, 2, 4,6 and after each extra dose of Antivenom

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJan 2009
  4. Study completionMar 2009

Why it stopped: Administrative reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00639951
Sponsor's protocol ID
YA-07/01
Status last verified
Jul 2016
First submitted
13 Mar 2008
Last updated
20 Jul 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: Not yet decided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing A and Antivipmyn ® in people with Snake Bite, run by Instituto Bioclon S.A. de C.V. at 5 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administrative reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution of systemic signs and symptoms of snake bite envenomation expressed as % of patients requiring additional antivenom and % of patients that are stable (time frame: 12 hours after initial treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00639951.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.

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