AK579 (COBALT) | Aplastic Anemia and MDS International Foundation

ClinicalTrials.gov Identifier:

2016002067

Company

Akari Therapeutics

Contact Info

Dr. Wynne Weston-Davies

trial@akaritx.com

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

Dates

Start: August 2016
End: June 2017

Official Title

AK579 (COBALT)

Purpose

Coversin Global Study:  An Open-Label, Safety and Efficacy Trial in PNH Patients

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. Patients with a diagnosis of PNH confirmed by flow cytometry who, in the opinion of the Investigator, would benefit from treatment with a complement C5 inhibitor
  2.  Aged 18 and above. No upper age limit
  3. Males and females of childbearing potential must agree to use an adequate method of contraception. Females will have a negative pregnancy test before entry to the study
  4. Body weight ≥50kg
  5. The patient has given voluntary written informed consent
  6. Willing to receive immunisation against Neisseria meningitidis and antibiotic prophylaxis in accordance with the local practice of the PI at the trial site. Antibiotic prophylaxis must continue until at least 14 days after the end of complement inhibition by Coversin.
Exclusion Criteria: 
  1. Prior use of eculizumab (Soliris®) within 3 months of entry is prohibited
  2. Any other drug acting directly on the complement system is prohibited
  3. Chemotherapeutic agents within 3 months of enrolment in the study is prohibited
  4. Tizanidine, if using ciprofloxacin prophylaxis, is prohibited
  5. Known sensitivity to the excipients of meningococcal vaccines, ciprofloxacin or any other antibiotic being administered for purposes of meningitis prophylaxis
  6. Participation in other clinical trials within 4 weeks of signing the consent form
  7. Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom)
  8. History of active systemic autoimmune diseases other than the target condition. Dermatologic diseases such as psoriasis will not be a reason for exclusion unless there are associated systemic symptoms such as arthritis
  9. Any systemic disorder that could interfere with the evaluation of the study treatment (e.g. severe renal or hepatic disease that in the opinion of the Investigator would affect the outcome of the study or interfere with interpretation of results)
  10.   Failure to satisfy the investigator of fitness to participate for any other reason or any condition that, in the opinion of the Investigator, could increase the patient's risk by participating in the study or confound the outcome of the study

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