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.
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 …
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