Clinical trial

Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms

Name

AK578

Description

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

Trial arms

Trial start

2016-02-01

Estimated PCD

2018-03-20

Trial end

2018-03-20

Status

Completed

Phase

Early phase I

Treatment

Coversin

Patients enrolled in this protocol will initially be treated with an ablating dose of Coversin and daily repeat maintenance doses calculated according to body weight, the ablating dose to be 0.57mg/kg. Thereafter the daily repeat dose will be titrated according to clinical response and complement inhibition determined by CH50 ELISA. The initial repeat dose will be 25% of the ablating dose and this will be adjusted up or down if necessary once steady state is reached (5 days).

Arms:

Coversin (Nomacopan)

Other names:

rVA576, rEV576

Size

Primary endpoint

Measurement of Ratio of LDH to the Upper Limit of Normal (ULN)

Day 0 and Day 28

Number and Type of Adverse Events (AE)

2 years

Eligibility criteria

Inclusion Criteria: * Patients with known Paroxysmal Nocturnal Haemoglobinuria (PNH) * LDH \>=1.5 Upper Limit of Normal (ULN) * Resistance to Eculizumab proven by both a recognised C5 polymorphism on genetic screening and complement inhibition on CH50 ELISA of \<100% at concentrations of Eculizumab in excess of 50 μg/mL * Willing to self-inject Coversin daily or to receive daily subcutaneous injections by a home nurse or in a doctor's office or hospital clinic * Males or females taking adequate contraceptive precautions if of childbearing potential, 18 - 80 years of age * Body weight ≥50kg and ≤ 100kg * The patient has provided written informed consent. * Willing to avoid prohibited medications for duration of study * Must agree to take appropriate prophylactic precautions against Neisseria infection. * Must be counselled regarding the possible reproductive risks of using Coversin and be advised to use an adequate method of contraception pending further data on reproductive toxicology. Exclusion Criteria: * Body weight \<50kg or\>100kg * Pregnancy (females) * Failure to satisfy the PI of fitness to participate for any other reason * Known allergy to ticks or severe reaction to arthropod venom (e.g., bee or wasp venom)

Protocol

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Updated at

2023-07-12

1 organization

1 product

1 indication

Product

Coversin

Indication

Paroxysmal Nocturnal Haemoglobinuria

Organization

Akari Therapeutics