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ICL670

Phase 3

Beta-Thalassemia | Small molecule | Hematology |Novartis AG|Last Updated: Feb 23, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment595

FDA Designations

No designations recorded

Clinical trial landscape

ICL670 · 3 trials · 3 indications

Phase 3 1Phase 2 2
NCT00061750Safety & Efficacy of ICL670 vs. Deferoxamine in Beta-thalassemia Patients With Iron Overload Due to Blood TransfusionsBeta-Thalassemia
COMPLETED595 Analytics
PHASE3COMPLETED
Safety & Efficacy of ICL670 vs. Deferoxamine in Beta-thalassemia Patients With Iron Overload Due to Blood Transfusions
Beta-ThalassemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
Number of Participants With Adverse Events After Start of ICL670
0 - 60 months

Safety as assessed by the number of participants with adverse event or death after the start of ICL670.

To evaluate the safety profile and to provide treatment with ICL670 for patients with or at risk of life-threatening complications due to transfusional iron overload who are unable to tolerate other iron chelators because of documented severe toxicity.
0 - 163 weeks

Secondary Endpoints

Evaluate tolerability profile
Estimate absolute and relative change of LIC and Total body iron excretion
Evaluation relationship between LIC and potential surrogate markers
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ICL670EXPERIMENTAL -
DeferoxamineACTIVE_COMPARATOR -

Interventions

NameTypeDescription
ICL670DRUG -
deferoxamineDRUG -
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Eligibility Criteria

Age Range2 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Beta-thalassemia patients already treated with or suitable for treatment with deferoxamine 20 to 40 mg/kg/day * Liver iron content greater than 2 mg iron/g dw as measured by liver biopsy * Need for regular transfusions 8 or more times per year Exclusion Criteria: * Non-trans...

Countries:United StatesCanadaFranceItalyUnited KingdomGreece
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Frequently asked questions about ICL670

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.