EUCTR2015-003778-34-NLActive, not recruitingPhase 1
Coversin in Paroxysmal Nocturnal Haemoglobulinuria (PNH) in patients with resistance to Eculizumab due to complement C5 Polymorphisms - Coversin in PNH patients with resistance to Eculizumab
Volution Immuno Pharmaceuticals (UK) Ltd0 sites6 target enrollmentStarted: December 10, 2015Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients with known paroxysmal nocturnal haemoglobinuria (PNH)
- •LDH >= 1.5 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 ug/ml
- •Willing to self-inject Coversin daily of to receive daily subcutaneous injections by a home nurse or in a doctor's office or hospital clinic.
- •Willing to receive appropriate prophylaxes against neisseria infection by either or both immunisation or continuous or intermittent antibiotics.
- •Males or females taking adequate contraceptives 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 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Body weight <50kg or >100kg
- •Pregnancy (females)
- •Use of tizanidine (if on ciprofloxacin)
- •Use of eculizumab should be discontinued before coversin therapy is commenced. Ideally this should be 2 of more weeks before.
- •Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom)
- •Failure to satisfy the PI off fitness to participate for any other reason.
Investigators
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