Phase 2
N=1
Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Bottom Line
View on ClinicalTrials.gov: NCT03427060 ↗Enrolled (actual)
1
Serious AEs
33.3%
Results posted
May 2025
Primary outcome: Primary: Measurement of Serum Lactate Dehydrogenase (LDH) — 2913; 3056; 1453; 564 U/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Coversin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AKARI Therapeutics
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Serum Lactate Dehydrogenase (LDH) |
2913; 3056; 1453; 564; 351; 368 | — |
| SECONDARY Percentage Change in Haemoglobin (Hb) Compared to Screening |
0; 28; 18; 22; 17; 25 | — |
| SECONDARY Number of Packed Red Blood Cells (PRBC) Transfusions |
1; 2; 1; 2 | — |
Summary
Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.
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 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.
Data sourced from ClinicalTrials.gov (NCT03427060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.