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ICL670, deferoxamine

Phase 2

Anemia, Sickle Cell | Small molecule | Hematology |Novartis AG|Last Updated: Aug 22, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment195

FDA Designations

No designations recorded

Clinical trial landscape

ICL670, deferoxamine · 1 trial · 1 indication

Phase 2 1
NCT00067080Safety of ICL670 vs. Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood TransfusionsAnemia, Sickle Cell
COMPLETED195 Analytics
PHASE2COMPLETED
Safety of ICL670 vs. Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood Transfusions
Anemia, Sickle CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the safety and tolerability of multiple doses of ICL670
1 year

Secondary Endpoints

Estimate the absolute and relative change of liver iron content (LIC) and total body iron excretion (TBIE)
at baseline, after 24 weeks and at 1year (end of study)
Evaluate the pharmacokinetics
24 hours post-dose @ 4, 12, 24 and 52 weeks
Evaluate the relationship between pharmacokinetics, pharmacodynamics and safety variables
at 24 and 52 weks pre-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ICL670 + deferoxamineEXPERIMENTAL -

Interventions

NameTypeDescription
ICL670, deferoxamineDRUG -
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Eligibility Criteria

Age Range2 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * Age greater than or equal to 2 years * Sickle cell disease patients already treated with or suitable for treatment with deferoxamine 20 to 40 mg/kg/day * Serum ferritin greater than 1000 mg/ml * Liver iron content greater than 2 mg iron/g dw assessed by means of superconductin...

Countries:United States
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Frequently asked questions about ICL670, deferoxamine

What is ICL670 used for?

ICL670 is an investigational small molecule being developed for beta-thalassemia, sickle cell disease, anemia, sickle cell, and transfusional iron overload. It is studied in patients with iron overload due to blood transfusions, including those with beta-thalassemia and sickle cell disease.

Who makes ICL670?

ICL670 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of ICL670 in patients with transfusional iron overload.

What phase is ICL670 in?

ICL670 is in Phase 3 clinical development. One Phase 3 trial has been completed, along with several Phase 2 trials. The drug is investigational and has not been approved by regulatory authorities, as it remains under clinical investigation.

What clinical trials is ICL670 in?

ICL670 has been studied in several completed trials. NCT00061750 is a Phase 3 trial in beta-thalassemia patients with iron overload. NCT00067080 and NCT01090323 are Phase 2 trials in sickle cell disease. NCT01044186 is a Phase 2 trial for patients with life-threatening complications of transfusional iron overload.

How does ICL670 compare to deferoxamine in trials?

In clinical trials, ICL670 has been compared to deferoxamine, an active control. The Phase 3 trial NCT00061750 evaluated safety and efficacy of ICL670 versus deferoxamine in beta-thalassemia patients. Other trials also used deferoxamine as a comparator in sickle cell disease and iron overload settings.