rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study

NCT ID: NCT03829449

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-13
• Study Completion Date: 2020-08-29

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 the parent trial has completed and patients treated under compassionate use or named patient arrangements who wish to continue on rVA576 (Coversin) therapy

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rVA576 Coversin

The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin) for up to 4 years.

Group Type: EXPERIMENTAL

rVA576

Intervention Type: DRUG

The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin).

Interventions

rVA576

The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin).

Intervention Type: DRUG

Other Intervention Names

nomacopan

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AKARI Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wynne Weston Davies

Role: STUDY_DIRECTOR

AKARI Therapeutics

Locations

Instytut Hematologii i Transfuzjologii

Warsaw, , Poland

Countries

Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AK581

Identifier Type: -

Identifier Source: org_study_id