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A-001

Phase 2

Sickle Cell Disease | Small Molecules | Hematology |Anthera Pharmaceuticals, Inc.|Trials Updated: Mar 4, 2014

A-001 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Feb 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

A-001 clinical trials

A-001 · 1 trial · 3 indications

Phase 2 1
NCT00434473IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest SyndromeSickle Cell Disease
COMPLETED30 Analytics
PHASE2COMPLETED
IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome
Sickle Cell Disease
NCT0043447330
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Study Endpoints

Primary Endpoints

To determine the safety and tolerability of different doses of A 001 therapy when administered as a 2-day continuous infusion to sickle cell disease (SCD) patients at-risk for the acute chest syndrome (ACS).
Study end

Secondary Endpoints

To determine the pharmacokinetic profile of A-001 in SCD patients
Study end
To confirm the ability of A-001 infusion to suppress serum sPLA2 activity in SCD patients with elevated serum sPLA2
Study end
To determine the efficacy of A-001 infusion in preventing ACS in SCD patients with the combination of vaso-occlusive crisis (VOC), fever, and elevated serum sPLA2
Study end
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
A-001EXPERIMENTAL -

Interventions

NameTypeDescription
A-001DRUGA-001
PlaceboOTHERPlacebo
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Eligibility Criteria

Age Range5 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Patients are eligible for inclusion if they meet the following criteria: * Sickle cell variant (Hb SS, Hb SC, sickle β°-thalassemia, sickle β+-thalassemia) * Pain consistent with vaso-occlusive crisis * Elevated serum sPLA2 level (measured on-site) * Fever * Age ≥5 years (through adult) Patients m...

Countries:United States
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Competitive Landscape -Sickle Cell Disease 38 trials

Top 11 of 12 competitors

CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO6PHASE3Etavopivat
Novartis AG Sponsored ADRNVS4PHASE3Crizanlizumab, ITU512, OTQ923
Agios Pharmaceuticals, Inc.AGIO3PHASE3Mitapivat, Tebapivat
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, Rilzabrutinib
Vertex Pharmaceuticals IncorporatedVRTX3PHASE3CTX001
Pfizer Inc.PFE1PHASE3Osivelotor
Bristol-Myers Squibb CompanyBMY1PHASE2BMS-986470
Travere Therapeutics, Inc.TVTX1PHASE3L-Citrulline
Beam Therapeutics, Inc.BEAM2PHASE2BEAM-101
Editas Medicine, Inc.EDIT2PHASE2EDIT-301
Disc Medicine, Inc.IRON1PHASE1DISC-3405
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