Fibrolase: Trials and Tribulations
Author Information
Author(s): Markland Francis S., Swenson Steve
Primary Institution: University of Southern California
Hypothesis
Can fibrolase serve as an effective thrombolytic agent compared to traditional methods?
Conclusion
Fibrolase shows promise as a rapid and effective thrombolytic agent, but clinical trials did not meet expected endpoints.
Supporting Evidence
- Fibrolase was shown to have very effective thrombolytic activity in a canine model.
- Alfimeprase was successful in Phase I and II clinical trials for peripheral arterial occlusion.
- Alfimeprase did not meet expected endpoints in Phase III trials.
Takeaway
Fibrolase is a special enzyme from snake venom that helps dissolve blood clots quickly, but it had mixed results in human tests.
Methodology
The enzyme was purified using a three-step HPLC procedure and tested in various animal models and clinical trials.
Potential Biases
Potential bias due to the involvement of multiple institutions and funding sources.
Limitations
The clinical trials faced issues with endpoints and enrollment, leading to the discontinuation of further development.
Participant Demographics
20 patients with chronic peripheral arterial occlusion, all over 18 years old.
Statistical Information
P-Value
0.022
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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