Trial Outcomes & Findings for Randomized, Double-Blind, Placebo-Controlled Study: CroFab® vs Placebo for Copperhead Snake Envenomation (NCT NCT01864200)

Last Updated: 2017-11-22

Results Overview

Patient Specific Functional Scale (PSFS) at 14 day follow-up This is a three-item instrument, administered verbally, that is used to evaluate whether a health condition impacts a patient's ability to perform activities that are important to him/her. On the initial assessment, the patient is asked to identify "up to three important activities that you are unable to do or are having difficulty with as a result of your (snakebite)." The patient then provides a rating for each item, on an 11-point ordinal scale ranging from 0 ("unable to perform activity") to 10 ("able to perform activity at the same level as before the injury or problem"). During reassessments, the subject is prompted to re-rate the same three activities. The average of up to 3 specific activity scores was recorded, and the range of possible scores is 0 - 10. Higher scores indicate less impairment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

74 participants

Primary outcome timeframe

at 14 day follow-up

Results posted on

2017-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	CroFab crotilidae polyvalent immune fab (ovine) per approved labeling crotilidae polyvalent immune fab (ovine): crotilidae antivenom	Saline Placebo Saline placebo Placebo
Overall Study STARTED	45	29
Overall Study COMPLETED	43	26
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	CroFab crotilidae polyvalent immune fab (ovine) per approved labeling crotilidae polyvalent immune fab (ovine): crotilidae antivenom	Saline Placebo Saline placebo Placebo
Overall Study Lost to Follow-up	1	3
Overall Study Protocol Violation	1	0

Baseline Characteristics

Randomized, Double-Blind, Placebo-Controlled Study: CroFab® vs Placebo for Copperhead Snake Envenomation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CroFab n=45 Participants Crotalidae Polyvalent Immune Fab (ovine) per approved labeling Crotalidae Polyvalent Immune Fab (ovine): crotalidae antivenom	Saline Placebo n=29 Participants Saline placebo Placebo	Total n=74 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 17.9 • n=5 Participants	42 years STANDARD_DEVIATION 17.2 • n=7 Participants	43.04 years STANDARD_DEVIATION 17.57 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	16 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	25 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	45 Participants n=5 Participants	29 Participants n=7 Participants	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: at 14 day follow-up

Outcome measures

Outcome measures
Measure	CroFab n=45 Participants crotilidae polyvalent immune fab (ovine) per approved labeling crotilidae polyvalent immune fab (ovine): crotilidae antivenom	Saline Placebo n=28 Participants Saline placebo Placebo
Patient Specific Functional Scale Score	8.62 units on a scale Standard Error 0.550	7.45 units on a scale Standard Error 0.603

Adverse Events

CroFab

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Saline Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CroFab n=45 participants at risk crotilidae polyvalent immune fab (ovine) per approved labeling crotilidae polyvalent immune fab (ovine): crotilidae antivenom	Saline Placebo n=29 participants at risk Saline placebo Placebo
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.2% 1/45 • Number of events 1 • Envenomation + 28 days	0.00% 0/29 • Envenomation + 28 days
Injury, poisoning and procedural complications Venom poisoning	0.00% 0/45 • Envenomation + 28 days	3.4% 1/29 • Number of events 1 • Envenomation + 28 days

Other adverse events

Other adverse events
Measure	CroFab n=45 participants at risk crotilidae polyvalent immune fab (ovine) per approved labeling crotilidae polyvalent immune fab (ovine): crotilidae antivenom	Saline Placebo n=29 participants at risk Saline placebo Placebo
Skin and subcutaneous tissue disorders Rash	6.7% 3/45 • Number of events 3 • Envenomation + 28 days	0.00% 0/29 • Envenomation + 28 days
Skin and subcutaneous tissue disorders Urticaria	11.1% 5/45 • Number of events 5 • Envenomation + 28 days	0.00% 0/29 • Envenomation + 28 days
General disorders Pyrexia	8.9% 4/45 • Number of events 4 • Envenomation + 28 days	0.00% 0/29 • Envenomation + 28 days
Gastrointestinal disorders Nausea	8.9% 4/45 • Number of events 4 • Envenomation + 28 days	6.9% 2/29 • Number of events 2 • Envenomation + 28 days
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 3/45 • Number of events 4 • Envenomation + 28 days	0.00% 0/29 • Envenomation + 28 days
Nervous system disorders Dizziness	8.9% 4/45 • Number of events 4 • Envenomation + 28 days	6.9% 2/29 • Number of events 3 • Envenomation + 28 days
Nervous system disorders Headache	11.1% 5/45 • Number of events 8 • Envenomation + 28 days	3.4% 1/29 • Number of events 1 • Envenomation + 28 days
Nervous system disorders Paraesthesia	6.7% 3/45 • Number of events 3 • Envenomation + 28 days	6.9% 2/29 • Number of events 2 • Envenomation + 28 days
Skin and subcutaneous tissue disorders Pruritus	11.1% 5/45 • Number of events 5 • Envenomation + 28 days	3.4% 1/29 • Number of events 1 • Envenomation + 28 days

Additional Information

Shirley Steiner, Director of Clinical Operations

BTG

Phone: 610 943 3631

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place