A study to determine the safety and tolerability of PF-05230907 in ICH
Research type
Research Study
Full title
A phase 1B multicentre, open-label study to evaluate the safety and tolerability and determine the maximum tolerated dose of PF-05230907 in subjects with intracerebral haemorrhage (ICH)
IRAS ID
199690
Contact name
Jamil Ahmed
Contact email
Sponsor organisation
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eudract number
2015-005703-83
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Spontaneous intracerebral haemorrhage (bleeding in the brain) is a major cause of death and disability accounting for approximately 10-15% of stroke cases worldwide. Intracerebral Haemorrhage (ICH) continues to be associated with poor clinical outcomes. Approximately 35-52% of patients die within one month, mortality at 6 months ranges from 23-58% and a large number of individuals fail to regain functional independence by six months. The current management of ICH is largely supportive and the lack of effective treatment for ICH remains a critical and unmet need.
In the body a blood clotting factor called FXa is involved a process that activates platelets in the blood to form a thrombus (a blood clot) to prevent bleeding. A thrombus is a healthy response to injury intended to prevent bleeding, but can be harmful in thrombosis, when clots obstruct blood flow through healthy blood vessels.
In principle, replacement therapy with direct FXa infusion could correct bleeding, however the therapeutic potential of FXa is limited as it does not last for very long in the blood and the potential for excessive coagulation due to activation of other coagulation factors.The study drug PF-0520907 being tested is a variant form of this coagulation factor FXa. PF-05230907 may establish, localised blood clotting without excessive risk of thrombosis, at the site of bleeding in a number of clinical situations of uncontrolled bleeding such as ICH. PF-05230907 is being developed as a single dose treatment for patients with ICH.
Due to the life threatening and severely disabling nature of ICH and the lack of effective treatment for ICH, treatment with PF 05230907 may have the potential for benefit in this vulnerable population.
This study will determine the maximum tolerated dose (MTD) of PF-05230907 and evaluate the safety and tolerability of a single administration of PF-05230907 in participants with ICH.There will be about 51 people taking part in this study. The study is being done at about 30 different hospitals in 6 countries (US, Canada, Germany, UK, Sweden and Spain).
REC name
Scotland A: Adults with Incapacity only
REC reference
16/SS/0134
Date of REC Opinion
14 Sep 2016
REC opinion
Further Information Favourable Opinion