CONSERVE: Coversin Long Term Study
Research type
Research Study
Full title
CONSERVE: Coversin Long Term Safety and Efficacy Surveillance Study
IRAS ID
220284
Contact name
Austin Kulasekararaj
Contact email
Sponsor organisation
Akari Therapeutics Plc
Eudract number
2016-004129-18
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) are extremely rare, life-threatening diseases of the blood, characterised by the destruction of red blood cells by the immune system. Breakdown of the red blood cells causes blood clots and anaemic symptoms such as fatigue. Both diseases are caused by one or several mutations in genes that result in uncontrolled and excessive activation of the ‘complement’ system (a part of the body’s immune system). High risk of blood clots results in renal failure in most patients.
Most therapies for PNH and aHUS aim to ease symptoms. Iron supplements and folic acid are usually given to patients to offset the high turnover of red blood cells. Blood transfusions may be required, or warfarin to reduce the risk of blood clots however both have risks and are not always effective. The only current therapy for PNH and aHUS is Eculizumab which inhibits the complement system, however this drug must be given by a healthcare professional every 2 weeks. There is an unmet need for the use of a more convenient treatment with fewer risks.
Akari Therapeutics PLC have developed a new drug, Coversin, that has been designed to inhibit the complement system.
This study is being done to demonstrate the long-term safety of Coversin in patients with PNH or aHUS who have received Coversin in previous clinical trials preceding entry in to this study.
This is an open-label, multicentre study which will take place across Europe, involving approximately 50 patients who have completed participation in preceding clinical trials with Coversin across Europe.
Patients will continue to receive Coversin by injection under the skin at the same dose as they were receiving at the end of the previous trial for 3 years.
REC name
London - Harrow Research Ethics Committee
REC reference
17/LO/0070
Date of REC Opinion
17 Mar 2017
REC opinion
Further Information Favourable Opinion