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NCT04784455

Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy

Terminated Phase 3 Results posted Last updated 5 June 2025
What this trial tests

Phase 3 trial testing nomacopan (rVA576) in Thrombotic Microangiopathies in 10 participants. Terminated before completion.

Timeline
1 February 2021
Primary endpoint
15 May 2024
15 May 2024

Quick facts

Lead sponsorAKARI Therapeutics
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date1 February 2021
Primary completion15 May 2024
Estimated completion15 May 2024
Sites9 locations across United Kingdom, United States, Poland

Drugs / interventions tested

Conditions studied

Sponsor

AKARI Therapeutics — full company profile →

Who can join

Adults 6 Months to 18, any sex, with Thrombotic Microangiopathies. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants NOT Requiring a Red Blood Bell Transfusion (Transfusion Independence) for 28 Days or More OR Number of Participants With a Urine Protein Creatinine Ratio Value of ≤ 2 mg/mg Maintained for 28 Days or More. Primary · 24 weeks

Red blood cell transfusion independence for ≥28 days immediately prior to any scheduled clinical visit up to Week 24 or Urine protein creatinine ratio ≤ 2 mg/mg maintained over ≥ 28 days immediately prior to any scheduled clinical visit up to week 24 Transfusion independence is defined as no RBC transfusion attributable to, or required to manage, thrombotic microangiopathy (TMA). Transfusions required for causes other than TMA will not be considered within the evaluation of the efficacy endpoints.

RBC transfusion independent for ≥ 28 days
GroupValue95% CI
Nomacopan2
Urine protein creatinine ratio (UPCR) ≤ 2 mg/mg for ≥ 28 days
GroupValue95% CI
Nomacopan4
Number of Participants With a Normalised sC5b-9 Value (Where sC5b-9 is the Same Value as the Upper Limit of Normal or Less) Secondary · 24 weeks

Plasma sC5b-9 ≤ upper limit of normal (ULN)

GroupValue95% CI
Nomacopan10
Number of Participants With a Normalised Lactate Dehydrogenase (LDH) Value (Where LDH is the Same Value as the Upper Limit of Normal or Less) Secondary · 24 weeks

Lactate dehydrogenase (LDH) ≤ULN

GroupValue95% CI
Nomacopan2
Normalisation of Lab Parameters Secondary · 24 weeks

Number of participants with a normalised haptoglobin value (where haptoglobin is within the normal ranges)

GroupValue95% CI
Nomacopan4
Number of Participants Not Requiring a Platelet Transfusion (Transfusion Independence) for 28 Days or More. Secondary · 24 weeks

Transfusion independence is defined as no platelet transfusion attributable to, or required to manage, thrombotic microangiopathy (TMA). Transfusions required for causes other than TMA will not be considered within the evaluation of the efficacy endpoints.

GroupValue95% CI
Nomacopan0

Adverse events — posted to ClinicalTrials.gov

Time frame: Duration of the study (Maximum of 2 year follow-up). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nomacopan - 1.7 mg/kg
Serious: 0/1 (0%)
Deaths: 0/1
Nomacopan - 1.3 mg/kg
Serious: 0/3 (0%)
Deaths: 0/3
Nomacopan - 1.0 mg/kg
Serious: 0/6 (0%)
Deaths: 0/6
Nomacopan - 0.30 mg/kg
Serious: 6/10 (60%)
Deaths: 4/10
Nomacopan - 0.45 mg/kg
Serious: 2/3 (67%)
Deaths: 0/3
Nomacopan - 0.60 mg/kg
Serious: 0
Deaths: 0

Serious adverse events (12 terms)

ReactionSystemNomacopan - 1.7 mg/kgNomacopan - 1.3 mg/kgNomacopan - 1.0 mg/kgNomacopan - 0.30 mg/kgNomacopan - 0.45 mg/kgNomacopan - 0.60 mg/kg
Multiple organ dysfunction syndromeGeneral disorders
Respiratory failureRespiratory, thoracic and mediastinal disorders
Cardiac arrestCardiac disorders
CytopeniaBlood and lymphatic system disorders
Device related infectionInfections and infestations
Generalised oedemaGeneral disorders
Generalised tonic-clonic seizureNervous system disorders
HypertensionVascular disorders
HypoglycaemiaMetabolism and nutrition disorders
Pneumonia parainfluenzae viralInfections and infestations
Posterior reversible encephalopathy syndromeNervous system disorders
Thrombotic microangiopathyBlood and lymphatic system disorders
Other adverse events (19 terms — click to expand)

ReactionSystemNomacopan - 1.7 mg/kgNomacopan - 1.3 mg/kgNomacopan - 1.0 mg/kgNomacopan - 0.30 mg/kgNomacopan - 0.45 mg/kgNomacopan - 0.60 mg/kg
HyperkalaemiaMetabolism and nutrition disorders
PyrexiaGeneral disorders
AnaemiaBlood and lymphatic system disorders
LeukopeniaBlood and lymphatic system disorders
HypermagnesaemiaMetabolism and nutrition disorders
ThrombocytopeniaBlood and lymphatic system disorders
HypokalaemiaMetabolism and nutrition disorders
NeutropeniaBlood and lymphatic system disorders
HypoalbuminaemiaMetabolism and nutrition disorders
HypernatraemiaMetabolism and nutrition disorders
HypotensionVascular disorders
HypocalcaemiaMetabolism and nutrition disorders
Blood Creatinine IncreasedInvestigations
HyponatraemiaMetabolism and nutrition disorders
Gamma-glutamyltransferase increasedInvestigations
HypophosphataemiaMetabolism and nutrition disorders
Blood bicarbonate decreasedInvestigations
HypoglycaemiaMetabolism and nutrition disorders
HypomagnesaemiaMetabolism and nutrition disorders

Most-reported serious reactions: Multiple organ dysfunction syndrome, Respiratory failure, Cardiac arrest, Cytopenia, Device related infection, Generalised oedema, Generalised tonic-clonic seizure, Hypertension.

Data from ClinicalTrials.gov NCT04784455 adverse events section.

Sponsor's own description

Multicentre Study of nomacopan in Paediatric Haematopoietic Stem-Cell Transplant Associated Thrombotic Microangiopathy

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Harmonizing Definitions for Diagnostic Criteria and Prognostic Assessment of Transplantation-Associated Thrombotic Microangiopathy: A Report on Behalf of the European Society for Blood and Marrow Transplantation, American Society for Transplantation and Cellular Therapy, Asia-Pac
    Schoettler ML, Carreras E, Cho B, Dandoy CE, et al · · 2023 · cited 91× · PMID 36442770 · DOI 10.1016/j.jtct.2022.11.015
  2. Role of the lectin pathway of complement in hematopoietic stem cell transplantation-associated endothelial injury and thrombotic microangiopathy.
    Gavriilaki E, Ho VT, Schwaeble W, Dudler T, et al · · 2021 · cited 28× · PMID 34924021 · DOI 10.1186/s40164-021-00249-8
  3. Outcomes from the International Society of Nephrology Hemolytic Uremic Syndromes International Forum.
    Kavanagh D, Ardissino G, Brocklebank V, Bouwmeester RN, et al · · 2024 · cited 15× · PMID 39395628 · DOI 10.1016/j.kint.2024.09.012
  4. Application of C5 inhibitors in glomerular diseases in 2021.
    Werion A, Rondeau E. · · 2022 · cited 15× · PMID 35354244 · DOI 10.23876/j.krcp.21.248
  5. Hematopoietic stem cell transplantation-associated thrombotic microangiopathy and the role of advanced practice providers and pharmacists.
    Mahmoudjafari Z, Alencar MC, Alexander MD, Johnson DJ, et al · · 2023 · cited 12× · PMID 37059738 · DOI 10.1038/s41409-023-01951-3
  6. Complement activation in secondary thrombotic microangiopathies.
    Morelle J, Caravaca-Fontan F, Fakhouri F, Frangou E, et al · · 2025 · cited 9× · PMID 40372375 · DOI 10.1093/ndt/gfaf091
  7. Atypical hemolytic uremic syndrome: diagnosis, management, and discontinuation of therapy.
    Java A. · · 2024 · cited 8× · PMID 39644051 · DOI 10.1182/hematology.2024000543
  8. Transplant-associated TMA: the conundrum of diagnosis and treatment.
    Li A, Sartain SE. · · 2024 · cited 6× · PMID 39644048 · DOI 10.1182/hematology.2024000545

Verify or expand the search:

Other trials of nomacopan (rVA576)

Trials testing the same drug.

Other recruiting trials for Thrombotic Microangiopathies

Currently open trials in the same condition.

Other AKARI Therapeutics trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04784455.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing