Trial Outcomes & Findings for A Comparison of Crotalinae Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab, (NCT NCT00868309)
NCT ID: NCT00868309
Last Updated: 2016-04-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Follow up after Maintenance doses were completed. Two Weeks.
Results posted on
2016-04-18
Participant Flow
Subjects arriving at participating centers with a pit viper bite were evaluated with respect to the inclusion/exclusion criteria.
Participant milestones
| Measure |
Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom
Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
|
CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom
CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Crotalinae Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab,
Baseline characteristics by cohort
| Measure |
Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom
n=6 Participants
Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
|
CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom
n=6 Participants
CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 16.5 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Follow up after Maintenance doses were completed. Two Weeks.Outcome measures
| Measure |
Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom
n=6 Participants
Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
|
CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom
n=6 Participants
CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
|
|---|---|---|
|
Detection of Plasma Venom Levels During the Post Acute Treatment Period.
Detectable venom
|
0 participants
|
4 participants
|
|
Detection of Plasma Venom Levels During the Post Acute Treatment Period.
Undetectable venom
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Follow up after maintenance doseThrombocytopenia during follow up period. Two weeks
Outcome measures
| Measure |
Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom
n=6 Participants
Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
|
CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom
n=6 Participants
CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
|
|---|---|---|
|
>50,000 Platelets/mm3
Thrombocytopenia present
|
0 participants
|
3 participants
|
|
>50,000 Platelets/mm3
Thrombocytopenia absent
|
6 participants
|
3 participants
|
Adverse Events
Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom
n=6 participants at risk
Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
|
CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom
n=6 participants at risk
CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
|
|---|---|---|
|
Blood and lymphatic system disorders
Rehospitalization for treatment of thrombocytopenia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom
n=6 participants at risk
Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
|
CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom
n=6 participants at risk
CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Chest discomfort
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Puncture site hemorrhage
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ecchymosis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
dry skin
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
dermatitis contact
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
pruritus generalised
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
petechiae
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
erythema
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
pruritus
|
33.3%
2/6 • Number of events 2
|
83.3%
5/6 • Number of events 5
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
axillary pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
fatigue
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
hypoaesthesia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
migraine
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
burning sensation
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
headache
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
paraesthesia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
tremor
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal discomfort
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
insomnia
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Blood and lymphatic system disorders
anaemia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Investigations
body temperature increased
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
anorexia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Reproductive system and breast disorders
genital pruritus female
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
hypotension
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60