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Ferrum Lek, chewable

Phase 3

Mild and Moderate Iron-deficiency Anaemia | Small molecule | Hematology |Novartis AG|Last Updated: Jul 12, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment267

FDA Designations

No designations recorded

Clinical trial landscape

Ferrum Lek, chewable · 1 trial · 1 indication

Phase 3 1
NCT03993288Study to Test the Hypothesis of Non-inferior Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia), as Compared With MALTOFER® (Vifor S.A., Switzerland), in Subjects With Mild and Moderate Iron Deficiency Anemia.Mild and Moderate Iron-deficiency Anaemia
COMPLETED267 Analytics
PHASE3COMPLETED
Study to Test the Hypothesis of Non-inferior Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia), as Compared With MALTOFER® (Vifor S.A., Switzerland), in Subjects With Mild and Moderate Iron Deficiency Anemia.
Mild and Moderate Iron-deficiency Anaemia
NCT03993288267
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Study Endpoints

Primary Endpoints

Change From Baseline in Blood Hemoglobin Level (g/L)
Baseline and Week 12

Changes in blood hemoglobin level (g/L) after 12-weeks of iron-deficiency anaemia treatment, a non-inferiority comparison, as compared with the baseline value (screening visit) between Ferrum Lek® and MALTOFER® groups

Secondary Endpoints

Change From Baseline in Serum Iron
Baseline, Week 4, 8 and 12
Change From Baseline in Transferrin
Baseline, Week 4, 8 and 12
Change From Baseline in Percent Transferrin Saturation
Baseline, Week 4, 8 and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ferrum LekEXPERIMENTALParticipants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
MALTOFERACTIVE_COMPARATORParticipants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks

Interventions

NameTypeDescription
Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia)DRUGParticipants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland)DRUGParticipants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: 1. The signed and dated written informed consent prior to participation in the study. 2. Men and women aged 18 and older (by the time of screening). 3. Outpatients. 4. Diagnosed iron-deficiency anemia, based on two criteria: 1. hemoglobin level below 110 g/L (in men and wome...

Countries:Russia
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