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

ConditionChronic Primary Immune Thrombocytopenia (ITP)

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-70

SponsorKedrion S.p.A.

About this trial

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

Eligibility criteria

Qualifiers

Male or female, 18-70 years of age.

Patient 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 7 days prior to screening. The second qualifying count will be measured within 7 days before the first KIg10 infusion.

Disqualifiers

Patients incapable of giving informed consent.

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.