rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study

Phase 3

Completed

Conditions: PNH (acquired heolitic anemia) and aHUS (disruptionof the complement system)
10018911

Registration Number: NL-OMON48556

Lead Sponsor: Akari Therapeutics Plc

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1

Inclusion Criteria

1) Patients 18 years and above successfully treated with rVA576 (Coversin) under other Akari clinical trial protocols and wish to remain on rVA576 (Coversin) at the conclusion of that trial
2) In the opinion of the treating responsible clinician patient is receiving clinical benefit from continued treatment with study drug.
3) Evidence of sustained total complement inhibition by CH50 assay
4) Women of childbearing potential (WOCBP) must agree to use effective contraception consistently throughout the study and have a negative pregnancy test at screening. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of amenorrhea and considered sterile if they have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks previously.
5) Males with a childbearing potential partner must agree to use effective contraception consistently OR have had a vasectomy.
6) Weight >50kg.
7) Received appropriate prophylaxis against Neisseria meningitidis infection, by both immunisation and continuous or intermittent antibiotics.
8) Patient is willing to give voluntary written informed consent.
9) The patient is willing in the process of preparation and self
administration of the study drug.

Exclusion Criteria

1) Patient experienced any safety event in the previous study protocol, which puts the patient at unacceptable risk in the current protocol in the clinical judgement of the investigator and sponsor.
2) Patient is unwilling to complete the Quaity of Life instruments and diary card
3) Evidence of active meningococcal infection (swab testing not required)
4) On concurrent treatment with another complement inhibitor
5) If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 90 days after last dose; or intending to donate ova during such period.
6) If male, the subject intends to donate sperm during this study or for 90 days after last dose.
7) Failure to satisfy the Investigator of fitness to participate for any reason or condition which, in the opinion of the investigator, cold increase the subject's risk from participating in the study or confound
the outcome of the study.
8) Use of prohibited medication (e.g. eculizumab (Soliris®)
9) The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within one year prior to screening.
10) Participation in other clinical trials with investigational product.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Safety and Efficacy Endpoints:<br /><br>Long term safety of rVA576 (Coversin) as assessed by SAEs, AEs, vital signs,<br /><br>immunogenicity assessments, results of appropriate standard laboratory tests<br /><br>(clinical chemistry, haematology, coagulation, urinalysis, and ADA) and results<br /><br>of electrocardiograms (ECGs).</p><br>

Secondary Outcome Measures