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

Recruiting Phase 3 Interventional Study
Chronic Primary Immune Thrombocytopenia (ITP)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Kedrion S.p.A. · Industry
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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

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female, 18-70 years of age. 2. Patient has signed the ICF. 3. Diagnosis of chronic (\> 12 months duration) ITP as defined by the International Working Group. 4. Mean screening platelet count of \< 30 × 10\^9/L from two qualifying counts measured at least one calendar …
Contacts

Anna Lotti Suffredini

+39 338 6827568

a.lotti@kedrion.com

CONTACT

Linda Karpiak

973-216-0484

l.karpiak@kedrion.com

CONTACT