Status:
COMPLETED
Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms
Lead Sponsor:
AKARI Therapeutics
Conditions:
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.
Detailed Description
Coversin, a small protein complement C5 inhibitor which prevents the cleavage of C5 by C5 convertase into C5a and C5b, will be used in an open label, non-comparative clinical trial in patients with PN...
Eligibility Criteria
Inclusion
- Patients with known PNH.
- Aged 18 and above. No upper age limit.
- Lactate dehydrogenase (LDH) ≥1.5 upper limit of normal.
- Must agree to use two methods of contraception that are ≥99% effective in preventing pregnancy.
- Resistance to eculizumab (Soliris®).
- Voluntary written informed consent.
- Willing to self-inject Coversin daily.
- Willing to receive appropriate prophylaxis against Neisseria infection.
- Willing to avoid prohibited medications for duration of study.
Exclusion
- Subjects with body weight \<50 kg (110 lb) or \>100 kg (220 lb).
- Pregnancy or breast feeding (females).
- Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).
- Unresolved Neisseria meningitidis infection.
- Patients who have not received adequate immunization against Neisseria meningitides.
- Impaired hepatic function.
- Patients with impaired renal function.
- Failure to satisfy the Principal Investigator (PI) of fitness to participate for any other reason.
Key Trial Info
Start Date :
May 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03427060
Start Date
May 14 2018
End Date
February 3 2021
Last Update
May 4 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065