Myelodysplastic Syndrome Clinical Trial

Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms

Summary

Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.

View Full Description

Full Description

Coversin, a small protein complement C5 inhibitor which prevents the cleavage of C5 by C5 convertase into C5a and C5b, will be used in an open label, non-comparative clinical trial in patients with PNH and proven resistance to eculizumab due to C5 polymorphisms. Patients will be treated with Coversin by daily subcutaneous injection for 6 months in order to determine the safety and efficacy of the drug in these circumstances. If satisfactory control of the PNH is achieved, and at the discretion of the Principal Investigator (PI), patients will have the option of remaining on Coversin and being entered into the long term follow-up study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients with known PNH.
Aged 18 and above. No upper age limit.
Lactate dehydrogenase (LDH) ≥1.5 upper limit of normal.
Must agree to use two methods of contraception that are ≥99% effective in preventing pregnancy.
Resistance to eculizumab (Soliris®).
Voluntary written informed consent.
Willing to self-inject Coversin daily.
Willing to receive appropriate prophylaxis against Neisseria infection.
Willing to avoid prohibited medications for duration of study.

Exclusion Criteria:

Subjects with body weight <50 kg (110 lb) or >100 kg (220 lb).
Pregnancy or breast feeding (females).
Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).
Unresolved Neisseria meningitidis infection.
Patients who have not received adequate immunization against Neisseria meningitides.
Impaired hepatic function.
Patients with impaired renal function.
Failure to satisfy the Principal Investigator (PI) of fitness to participate for any other reason.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT03427060

Recruitment Status:

Enrolling by invitation

Sponsor:

AKARI Therapeutics

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT03427060

Recruitment Status:

Enrolling by invitation

Sponsor:


AKARI Therapeutics

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider