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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Kedrion S.p.A.
Study ID
NCT07059000
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chronic Primary Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Kedrion IVIG 10% — BIOLOGICAL
    (Intravenous) Human Normal Immunoglobulin (IVIg) 10%

Study Details

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

Key Dates

Start date
Aug 13, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 2 g/kg Kedrion IVIg 10%
    Subjects will receive one course of treatment with 2 g/kg of Kedrion IVIg 10% administered over 2 days

Primary Outcome Measure

Rate of subjects with response (R) [ Time Frame: Treatment to day 14 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033-
East Carolina UniversityGreenvilleNorth Carolina27834-

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By research site
University of Southern California· Los Angeles, CAEast Carolina University· Greenville, NC