rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study

• Register: ClinicalTrials.gov
• Last refreshed on: 5 July 2021
• Main ID: NCT03829449
• Date of registration: 20/12/2018
• Prospective Registration: No
• Primary sponsor: AKARI Therapeutics
• Public title: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study CONSERVE
• Scientific title: CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study
• Date of first enrolment: March 13, 2017
• Target sample size: 15
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03829449
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Poland

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. In the opinion of the treating responsible clinician patient is receiving clinical
benefit from continued treatment with study drug.

3. Evidence of sustained 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 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.

5. Males with a childbearing potential partner must agree to use effective contraception
consistently OR have had a vasectomy

6. Weight =50-100kg

7. Willing to receive appropriate prophylaxis against Neisseria meningitidis infection,
by both immunisation and continuous or intermittent antibiotics

8. The 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 current protocol as judged by the investigator and
sponsor.

2. Patient is unwilling to complete the Quality of Life instruments and diary card

3. Active meningococcal infection (section 4.3.1 for additional information)

4. 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).

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 time period.

6. If male, the subject intends to donate sperm while on the study this study or for 90
days after last dose.

7. 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.

8. Use of prohibited medication

9. The subject has a history of drug abuse (defined as any illicit drug use) or a history
of alcohol abuse.

10. Participation in other clinical trials with investigational product.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Paroxysmal Nocturnal Hemoglobinuria

Intervention(s)

Drug: rVA576 (Coversin)

Primary Outcome(s)

Long term safety and efficacy of rVA576 (Coversin) therapy assessed by AEs, SAEs, Standard Lab tests and ECG results. [Time Frame: 4 years]

Secondary Outcome(s)

Proportion of subjects with median serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 times the upper limit of normal (ULN) over the entire duration of the study. [Time Frame: 4 years]

Time to first Major Adverse Vascular Event (MAVE) for each subject since joining the study. [Time Frame: 4 years]

Time to thrombotic or haemolytic event since joining this study. [Time Frame: 4 years]

Proportion of subjects with serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 times the upper limit of normal (ULN) at each 3-month time period since the start of the study. [Time Frame: 12 weeks]

Proportion of subjects with no adverse change in overall scores of Quality of Life using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F instruments at each 3-month time period since the start of the study. [Time Frame: 12 weeks]

Number of Major Adverse Vascular Events (MAVE) over the entire period of the study. [Time Frame: 4 years]

Proportion of patients experiencing Major Adverse Vascular Events (MAVE) over the entire period of the study. [Time Frame: 4 years]

Time to first transfusion since joining the study. [Time Frame: 4 years]

Proportion of subjects who require PRBC transfusion during each 3-month period since the start of the study and over the entire period of the study [Time Frame: 4 years]

Proportion of subjects with thrombotic and haemolytic event free status during each 3month time period since the start of the study. [Time Frame: 12 weeks]

Proportion of transfusion-independent subjects at each 3-month time point, with haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE [Time Frame: 3 monthly]

Proportion of transfusion-independent subjects over the entire duration of the study with mean haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE [Time Frame: 12 weeks]

Secondary ID(s)

AK581

Source(s) of Monetary Support

Please refer to primary and secondary sponsors