Status:
TERMINATED
rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study
Lead Sponsor:
AKARI Therapeutics
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Long term management of patients with complement related diseases including Paroxysmal Nocturnal Haemoglobinuria and Atypical Haemolytic Uraemic Syndrome
Detailed Description
Patients with diseases requiring complement inhibition who have previously taken part in Akari clinical trials and who wish to continue to receive rVA576 (Coversin) after their active participation in...
Eligibility Criteria
Inclusion
- Patients 18 years and above treated with rVA576 (Coversin) under other Akari clinical trial protocols and wish to remain on rVA576 (Coversin) at the conclusion of that trial.
- In the opinion of the treating responsible clinician patient is receiving clinical benefit from continued treatment with study drug.
- Evidence of sustained complement inhibition by CH50 assay. .
- Women of childbearing potential (WOCBP) must agree to use effective contraception consistently throughout the study and have a negative pregnancy test at screening and a negative urine pregnancy test per the schedule of visits. Women cannot donate their eggs. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of amenorrhea or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks previously.
- Males with a childbearing potential partner must agree to use effective contraception consistently OR have had a vasectomy
- Weight ≥50-100kg
- Willing to receive appropriate prophylaxis against Neisseria meningitidis infection, by both immunisation and continuous or intermittent antibiotics
- The patient is willing to give voluntary written informed consent
- The patient is willing in the process of preparation and self-administration of the study drug.
Exclusion
- Patient experienced any safety event in the previous study protocol, which puts the patient at unacceptable risk in current protocol as judged by the investigator and sponsor.
- Patient is unwilling to complete the Quality of Life instruments and diary card
- Active meningococcal infection (section 4.3.1 for additional information)
- Any other reason for which, in the opinion of the Investigator, it would not be in the interests of the patient to remain on rVA576 (Coversin).
- 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 time period.
- If male, the subject intends to donate sperm while on the study this study or for 90 days after last dose.
- Failure to satisfy the Investigator of fitness to participate for any other reason or any other condition which, in the opinion of the investigator, could increase the subject's risk by participating in the study or confound the outcome of the study.
- Use of prohibited medication
- The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse.
- Participation in other clinical trials with investigational product.
Key Trial Info
Start Date :
March 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03829449
Start Date
March 13 2017
End Date
August 29 2020
Last Update
April 10 2025
Active Locations (1)
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1
Instytut Hematologii i Transfuzjologii
Warsaw, Poland, 02-776