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

NCT07059000 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-06

No results posted yet for this study

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

Conditions

  • Chronic Primary Immune Thrombocytopenia (ITP)

Interventions

BIOLOGICAL

Kedrion IVIG 10%

(Intravenous) Human Normal Immunoglobulin (IVIg) 10%

Sponsors & Collaborators

  • Kedrion S.p.A.

    lead INDUSTRY

Principal Investigators

  • Mirella Calcinai, MD · Kedrion S.p.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-13
Primary Completion
2026-12-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Italy
  • Romania
  • Serbia
  • Spain
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07059000 on ClinicalTrials.gov