Clinical Trials of new bivalent snake antivenom immunoglobulins (IgG) for the treatment of envenoming by medically important vipers in Sindh (Phase II study)
Study objective: To evaluate the estimated dose and to determine the effective dose of bivalent snake antivenom immunoglobulins (IgG) in snake bite patients. The main inclusion criteria includes: envenoming by Saw Scaled Viper and Russell’s viper (Daboia Russelii); age above 18 years; 20WBCT shows incoagulable blood; with no (anaphylactic) reaction within 10-30 minutes after initial test dose of investigational product (test ASV); Patient or his/her legally acceptable representative able to understand the informed consent and enter into the study with their free will. The main exclusion criteria includes: patient refusal to take newly produced ASV as the core remedy; chronic or complicating medical conditions, any neuropathy, renal impairment, liver diseases, diabetes mellitus, Hypertension and any CV disease; hypersensitivity to horse (equine) or sheep (ovine) serum in the past and a strong history of atopic diseases (especially severe asthma). Study Population & Sample Size: Total twelve (12) Local Pakistani victims of viper snake’s bite will participate; six (6) of each specie; Echis carinatus sochureki & Daboia russelii. Intervention: Intravenous administration of Bivalent snake antivenom immunoglobulins (IgG) effective against Echis carniatus and Daboia russelli envenoming found in Sindh. Initial dose: 3 vials (30ml) for Daboia russelii and 1 vial (10ml) for Echis carinatus. Outcome Measures: The dose at which maximum patients are treated (permanent restoration of blood coagulability tested by 20WBCT at 6, 12, 18 and 24 hours after dosing) with minimum toxicity. The secondary outcome includes the Incidences of anaphylactic like reactions, pyrogenic reaction and late serum sickness-type reactions
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070218314N1
Registration date:2014-10-07, 1393/07/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-07, 1393/07/15
Registrant information
Name
Naeem Quraishi
Name of organization / entity
Antisnake Venom and Antirabies Serology laboratory
Country
Pakistan
Phone
00922449370260
Email address
pd_naeem@asvsindh.gos.pk
Recruitment status
Recruitment complete
Funding source
Department of health, Government of Sindh, Pakistan
Expected recruitment start date
2014-10-20, 1393/07/28
Expected recruitment end date
2015-03-25, 1394/01/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trials of new bivalent snake antivenom immunoglobulins (IgG) for the treatment of envenoming by medically important vipers in Sindh (Phase II study)
Public title
Clinical Trial of a new snake antivenom for the treatment of viper snake bites in Sindh.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteris: Patient envenomed by Saw Scaled Viper (Echis carinatus Sochureki/ lundi) and Russell’s viper (Daboia Russelii/Daman/Koriala); Adult male or female (non-pregnant) above 18 years. Reached hospital within few hours (within 0-7 hours) of snake bite. However the late reaching patients will be treated according to provincial protocol of snakebite management without inclusion in the study; Snake specie is confirmed by identification of dead snake or the clinical observation of incoagulable blood, or when a description of snake is associated with symptoms and signs consistent with systemic envenoming by viper species such as incoagulable blood, spontaneous systemic bleeding, intravascular hemolysis, (pink plasma, anemia, hemoglobinuria), acute renal failure or oliguria; 20WBCT shows incoagulable blood; Patients show no early (anaphylactic) reaction within 10-30 minutes (itching, urticaria, fever, nausea, vomiting, tachycardia, hypotension, bronchospasm) on administration of 0.3ml of test ASV as initial dose; Patient or his/her legally acceptable representative able to understand the informed consent and enter into the study with their free will by signing the same.
Exclusion Criteria: Not willing to accept newly produced ASV as the core remedy; Debilitated patients and those with other chronic or complicating medical conditions, any neuropathy, renal impairment, liver diseases, diabetes mellitus, Hypertension and any CV disease; Subject with known hypersensitivity to horse (equine) or sheep (ovine) serum in the past (for example after treatment with equine anti-tetanus serum, equine anti-rabies serum or equine or ovine anti-venom) and those with a strong history of atopic diseases (especially severe asthma); Patients showing reaction to initial dose of test ASV; Patients with severe condition, acute renal failure, anuria, generalized rhabdomyolysis evident with myoglobinuria and haemoglobinuria; Pregnant women and patients under 18 years of age; not bitten by any medically important vipers of Sindh.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Single arm dose finding study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Peoples University of medical & health sciences for women Shaheed Benazir Abad.
Street address
Peoples University of medical & health sciences for women , Shaheed Benazir Abad,
City
Nawabshah
Postal code
67450
Approval date
2014-05-14, 1393/02/24
Ethics committee reference number
IRB/IEC/lett-A01
Health conditions studied
1
Description of health condition studied
treatment of envenomation
ICD-10 code
T63.0
ICD-10 code description
Toxic effect of snake venom
Primary outcomes
1
Description
permenant restoration of blood coagulability
Timepoint
6, 12, 18 and 24 hours after dosing.
Method of measurement
measured through 20 minutes whole blood clotting test
Secondary outcomes
1
Description
early and late snake antivenom reactions
Timepoint
after test dose and ful initial dose patients will be monitored for early reaction while patients will be checked on weekly basis for next 24 days after dosing for late serum reaction.
Method of measurement
through clinical sign and symptoms and adverse evnt monitoring
Intervention groups
1
Description
Test drug: Snake antivenom immunoglobulin (IgG)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
District Headqarter Hospital Mithi and peoples medical university hospital Nawabshah
Full name of responsible person
Dr. Naeemul Haque Quraishi, Principal Investigator
Street address
Snake antivenom/antirabies serology lab, old DHo office, Sakrand road
City
Nawabshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of health, Governement of Sindh
Full name of responsible person
Dr. Hafeezul Haque Director General Health Sindh
Street address
Directorate General Health Services Sindh Wahdat Colony
City
Huderabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of health, Governement of Sindh
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Institute of Biochemistry University of Sindh Jamshoro
Full name of responsible person
Professor Dr. Allah Bux Ghanghro Principal Scientific Consultant
Position
Deputy Project Director
Other areas of specialty/work
Street address
Snake antivenom/antirabies serology lab, old DHO office, Sakrand road