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Crofab

Clinical Pharmacology
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Clinical Pharmacology

Crofab

The ICA was based on the investigator†s clinical judgment as to whether the patient had a:

† Clinical response (pre-treatment signs and symptoms of envenomation were arrested or improved after treatment)

† Partial response (signs and symptoms of envenomation worsened, but at a slower rate than expected after treatment)

† Non-response (the patient†s condition was not favorably affected by the treatment).

Safety was assessed by monitoring for early allergic events, such as anaphylaxis and early serum reactions during CroFab infu-sion, and late events, such as late serum reactions.

TAb001:

In the first clinical study of CroFab, 11 patients received an intravenous dose of 4 vials of CroFab over 60 minutes. An additional 4-vial dose of CroFab was administered after completion of the first CroFab infusion, if deemed necessary by the investigator. At the 1-hour assessment,10 out of 11 patients had no change or a decrease in their ES. Ten of 11 patients were also judged to have a clinical response by the ICA. Several patients, after initial clinical response, subsequently required additional vials of CroFab to stem progressive or recurrent symptoms and signs. No patient in this first study experienced an anaphylactic or anaphylactoid response or evidence of an early or late serum reaction as a result of administration of CroFab.

TAb002:

Based on observations from the first study, the second clinical study of CroFab compared two different dosage schedules. Patients were given an initial intravenous dose of 6 vials of CroFab with an option to retreat with an additional 6 vials,if needed, to achieve initial control of the envenomation syndrome. Initial control was defined as complete arrest of local manifestations, and return of coagulation tests and systemic signs to normal. Once initial control was achieved, patients were randomized to receive additional CroFab either every 6 hours for 18 hours (Scheduled Group) or as needed (PRN Group).

In this trial, CroFab was administered safely to 31 patients with minimal or moderate crotalid envenomation. All 31 patients enrolled in the study achieved initial control of their envenomation with CroFab, and 30,25 and 26 of the 31 patients achieved a clinical response based on the ICA at 1,6 and 12 hours respectively following initial control. Additionally, the mean ES was significantly decreased across the patient groups by the 12-hour evaluation time point (p=0.05 for the Scheduled Group; p=0.05 for the PRN Group) (see Table 4).There was no statistically significant difference between the Scheduled Group and the PRN Group with regard to the decrease in ES.

Table 4. Summary of Patient Efficacy Scores for Scheduled and PRN Groups

Time Period

Scheduled Group (n=15) Efficacy Score* Mean± SD

PRN Group (n=16) Efficacy Score* Mean ± SD

Baseline

4.0 ± 1.3

4.7 ± 2.5

End of Initial Control Antivenin Infusion(s)

3.2 ± 1.4

3.3 ± 1.3

1 hour after Initial Control achieved

3.1 ± 1.3

3.2 ± 0.9

6 hours after Initial Control achieved

2.6 ± 1.5

2.6 ± 1.3

Brand Name: Crofab
Generic Name: Crotalidae Polyvalent Immune Fab Ovine
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