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CONSERVE: rVA576 Long Term Safety and Efficacy Surveillance
NCT03829449Phase 3
Key facts
- Status
- Terminated
- Start
- Mar 2017
- Primary completion
- Aug 2020
- Countries
- 1
- Sponsor
- Akari Therapeutics
- Modality
- rProtein (Recombinant Protein), Biologic
- Drugs
- nomacopan
- Conditions
- paroxysmal nocturnal hemoglobinuria (PNH)atypical hemolytic uremic syndrome (aHUS)
01
Overview
Phase 3, open-label, single-arm trial of nomacopan in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), sponsored by Akari Therapeutics. Primary endpoint: Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. Started Mar 2017; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
rVA576 Coversin
Patients continuing rVA576 (nomacopan) treatment from previous trials.
03
Who it enrols
Patients 18 years and above who have completed a previous Akari clinical trial with rVA576 (nomacopan) and wish to continue treatment. Patients must have evidence of sustained complement inhibition and be willing to receive meningococcal prophylaxis.
04
Endpoints
Primary
Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results
Secondary
Proportion of Subjects With Thrombotic and Haemolytic Event Free Status
Time to Thrombotic or Haemolytic Event Since Joining This Study
Proportion of Subjects Who Require PRBC Transfusion
Time to First Transfusion Since Joining the Study
Proportion of Subjects With no Adverse Change in Overall Scores of Quality of Life
Proportion of Subjects With Serum Lactate Dehydrogenase (LDH) Categories
Proportion of Transfusion-independent Subjects With Haemoglobin Above Baseline
Major Adverse Vascular Events (MAVE)
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