RecruitingPhase 3

A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)

United States, Czechia, Germany40 participantsStarted 2025-08-13

Plain-language summary

The purpose of this study is to evaluate the efficacy and safety of KIg 10 (Intravenous Immunoglobulin 10%) in adult patients with chronic primary ITP

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Male or female, 18-70 years of age.
✓. Patient and/or legal authorized representative has signed the ICF.
✓. Diagnosis of chronic (\> 12 months duration) ITP as defined by the International Working Group.
✓. Mean screening platelet count of \< 30 × 10\^9/L from two qualifying counts measured at least one calendar day apart. The first qualifying count can be from historical data if measured within 14 days prior to the first KIg10 infusion. The second qualifying count will be measured within 7 days before the first KIg10 infusion.
✓. Platelet count of \< 30 × 10\^9/L at the Baseline Visit.
✓. Patient is willing to comply with all requirements of the protocol.
✓. Women of childbearing potential must have a negative urine pregnancy test at screening and agree to employ adequate birth control measures during the study.
✓. Authorization to access personal health information.

Exclusion criteria

✕. Patients with secondary ITP (all forms of immune-mediated thrombocytopenia except primary ITP). e.g., lupus erythematosus, rheumatoid arthritis, drug-related ITP, and Human Immunodeficiency Virus (HIV).
✕. Patients with Evans Syndrome.
✕. Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV.
✕. History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.
✕. Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients.
✕. Patient unresponsive previously to IVIg or anti-D Ig treatment.
✕. Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA.
✕. Splenectomy within 4 weeks of the Baseline Visit or planned splenectomy throughout the study period.

What they're measuring

Rate of subjects with response (R)

Timeframe: Treatment to day 14

Trial details

NCT IDNCT07059000

SponsorKedrion S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Anna Lotti Suffredini

+39 338 6827568 a.lotti@kedrion.com

View on ClinicalTrials.gov More Chronic Primary Immune Thrombocytopenia (ITP) trials