Phase 2
N=1
Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)
Paroxysmal Nocturnal Haemoglobinuria (PNH)
Bottom Line
View on ClinicalTrials.gov: NCT02591862 ↗Enrolled (actual)
1
Serious AEs
100.0%
Results posted
Jul 2023
Primary outcome: Primary: Measurement of Ratio of LDH to the Upper Limit of Normal (ULN) — 5.6; 1.9 Ratio of LDH:ULN (250 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
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Ratio of LDH to the Upper Limit of Normal (ULN) |
5.6; 1.9 | — |
| PRIMARY Number and Type of Adverse Events (AE) |
2; 20; 13; 1; 1; 18 | — |
| SECONDARY Measurement of Haemoglobin (Hb) at Days 28, 90, and 180, Absolute and Change From Baseline |
8.2; 7.8; -0.7; 7.8; -0.4; 8.0 | — |
| SECONDARY Measurement of Haptoglobin (Hp) at Days 28, 90 and 180, Absolute and Change From Baseline |
NA; NA; NA; NA | — |
| SECONDARY Measurement of Lactate Dehydrogenase (LDH) at Baseline, Day 90 and Day 180 |
5.6; 1.6; 1.5 | — |
| SECONDARY Change in Functional Assessment of Chronic Illness Therapy (FACIT) Score at Days 0, 28, 90 and 180 |
13.0; 13.3; 11.0 | — |
| SECONDARY Change in Quality Of Life Questionnaire (QOQ) Score at Days 0, 28, 90 and 180 |
16.7; 16.7; 16.7; 6.6; 0.0; 6.6 | — |
| SECONDARY Dependency on Blood Transfusion |
0; 0 | — |
Summary
Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.
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 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)
Data sourced from ClinicalTrials.gov (NCT02591862). 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.