Recent Updates
Recently added Catalysts

GE-145

Phase 2

Chronic Renal Insufficiency | Small molecule | Cardiovascular |GE HealthCare Technologies Inc.|Last Updated: Aug 29, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment284
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01252810Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary ProcedurePHASE2 COMPLETED 284 — — Nov 1, 2010Dec 1, 2012Aug 29, 20181 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.
After the imaging date for either Ioforminol or Iopamidol.

Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.

Secondary Endpoints
To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration
Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.
Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections
2, 6 and 24 hours post Ioforminol and Iopamidol adminstration
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
GE 145 320mg I/ml injectionEXPERIMENTAL -
Iopamidol 370mg I/ml injectionACTIVE_COMPARATOR -
Interventions
NameTypeDescription
GE-145DRUGGE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.
Unlock Study Design Details
Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Males and females 65 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI. * The subject has at least one of the following comorbidities: * 1\) Chronic renal insufficiency, (eGFR \<60 but 15 mL/min/1.73 m2 accor...

Countries:United States
Unlock Eligibility Criteria