Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms | Aplastic Anemia and MDS International Foundation

ClinicalTrials.gov Identifier:

NCT02591862

Company

Akari Therapeutics

Contact Info

Dr. Wynne Weston-Davies

trial@akaritx.com

+44 (0)20 7025 7911 or +44 (0)7801 281283

Dates

Start: February 2016
End: January 2017

Official Title

Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms

Purpose

Coversin in paroxysmal nocturnal haemoglobinuria (PNH) in patients with resistance to eculizumab due to complement C5 polymorphisms

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Recruiting
Associated Drug(s): 
Phase: 
Phase 2
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
Inclusion Criteria: 
  1. Males or females taking adequate contraceptive precautions if of childbearing potential, 18 – 80 years of age.
  2. Body weight ≥50kg and  ≤ 100kg.
  3. The patient has provided written informed consent.
  4. Willing to avoid prohibited medications for duration of study (see Exclusion Criteria).
  5. Must agree to take appropriate prophylactic precautions against Neisseria  infection.
  6. Must be counselled regarding the possible reproductive risks of using Coversin and be advised to use an adequate method of contraception pending further data on reproductive toxicology.
Exclusion Criteria: 
  1. Body weight <50kg or > 100kg
  2. Pregnancy

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