Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT07059000

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

Led by Kedrion S.p.A. · Updated on 2026-03-13

40

Participants Needed

27

Research Sites

50 weeks

Total Duration

On this page

Sponsors

K

Kedrion S.p.A.

Lead Sponsor

I

ICON plc

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 18-70 years of age.
  • Signed informed consent form by patient or legal representative.
  • Diagnosis of chronic (> 12 months) primary Immune Thrombocytopenia (ITP) as defined by the International Working Group.
  • Mean screening platelet count less than 30 x 10^9/L from two qualifying counts at least one day apart.
  • Platelet count less than 30 x 10^9/L at the Baseline Visit.
  • Willingness to comply with all study requirements.
  • Women of childbearing potential must have a negative urine pregnancy test at screening and agree to use adequate birth control during the study.
  • Authorization to access personal health information.
Not Eligible

You will not qualify if you...

  • Secondary ITP or other immune-mediated thrombocytopenias such as lupus, rheumatoid arthritis, drug-related ITP, or HIV.
  • Evans Syndrome.
  • Known infection with hepatitis B, hepatitis C, or HIV.
  • History of thrombotic events including deep vein thrombosis, stroke, pulmonary embolism, transient ischemic attacks, or myocardial infarction.
  • Hypersensitivity to IVIg, other injectable IVIg forms, or any excipients.
  • Previous unresponsiveness to IVIg or anti-D Ig treatment.
  • Known Immunoglobulin A (IgA) deficiency with antibodies against IgA.
  • Splenectomy within 4 weeks before Baseline Visit or planned during the study.
  • Known inherited thrombocytopenia such as MYH-9 disorders.
  • Myelodysplastic syndrome (MDS).
  • Use of certain immunosuppressive or platelet-enhancing treatments within specified time frames before Baseline Visit, except stable doses of some medications.
  • Blood or blood product transfusions within 1 month before Baseline Visit.
  • Rituximab treatment within 6 months before Baseline Visit.
  • Platelet transfusion or blood product containing platelets within 7 days before Day 1.
  • Recombinant activated factor VII within 7 days before Baseline Visit.
  • Live attenuated virus vaccines within 3 months before Baseline Visit.
  • Use of loop diuretics within 1 week before Baseline Visit.
  • High risk of thrombotic events.
  • Uncontrolled hypertension (diastolic >100 mmHg and/or systolic >160 mmHg).
  • Severe heart conditions including congestive heart failure NYHA III/IV, cardiomyopathy, arrhythmias with thromboembolic events, unstable ischemic heart disease, or hyperviscosity.
  • Significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.
  • Hyperproteinemia, increased serum viscosity, or hyponatremia.
  • Severe liver or kidney disease beyond specified laboratory limits.
  • Severe anemia with hemoglobin less than 7 g/dL or hemodynamic instability.
  • Body mass index over 40 kg/m2 or IVIg dose risk for fluid overload.
  • History of malignant disease within 3 years except certain skin or cervical cancers.
  • Participation in other investigational clinical studies within 30 days before Baseline Visit.
  • Any condition likely to interfere with study drug evaluation or study conduct as judged by the investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

University of Southern California

Los Angeles, California, United States, 90033

Actively Recruiting

2

East Carolina University

Greenville, North Carolina, United States, 27834

Actively Recruiting

3

Vseobecna Fakultni Nemocnice v Praze

Prague, Prague, Czechia, 128 08

Actively Recruiting

4

Fakultni Nemocnice Brno

Brno, South Moravian, Czechia, 625 00

Actively Recruiting

5

Onkologisches Zentrum Donauwörth Neudegger - Onkomedeor Onkologische Zentren

Donauwörth, Bavaria, Germany, 86609

Withdrawn

6

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany, 60590

Actively Recruiting

7

Azienda Ospedaliero - Universitaria Careggi

Florence, Florence, Italy, 50134

Actively Recruiting

8

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Novara, Novara, Italy, 28100

Actively Recruiting

9

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, Trieste, Italy, 34148

Actively Recruiting

10

Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

Torino, Turin, Italy, 10126

Actively Recruiting

11

AULSS 8 Berica - Ospedale San Bortolo Di Vicenza

Vicenza, Vicenza, Italy, 36100

Actively Recruiting

12

Coltea - Spital Clinic

Bucharest, Bucharest, Romania, 030 171

Actively Recruiting

13

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, Cluj, Romania, 400015

Actively Recruiting

14

Spitalul Filantropia - Craiova

Craiova, Dolj, Romania, 200143

Actively Recruiting

15

Univerzitetski Klinicki Centar Srbije

Belgrade, Serbia, 11000

Actively Recruiting

16

Klinicko-Bolnicki Centar Zemun

Belgrade, Serbia, 11080

Actively Recruiting

17

Complejo Asistencial Universitario de Burgos - Hospital Universitario de Burgos

Burgos, Burgos, Spain, 09006

Withdrawn

18

Instituto De Investigacion Biomedica De A Coruna - Virologia Clinica

A Coruña, La Coruña, Spain, 15006

Actively Recruiting

19

Complejo Hospitalario Ruber Juan Bravo

Madrid, Madrid, Spain, 28006

Actively Recruiting

20

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain, 28007

Actively Recruiting

21

Ankara Üniversitesi Tip Fakültesi - Cebeci Arastirma ve Uygulama Hastanesi

Ankara, Ankara, Turkey (Türkiye), 06100

Not Yet Recruiting

22

Kocaeli Üniversitesi Arastirma ve Uygulama Hastanesi

Ankara, Ankara, Turkey (Türkiye), 06680

Not Yet Recruiting

23

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Yenimahalle, Ankara, Turkey (Türkiye), 06200

Not Yet Recruiting

24

Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi

Edirne, Edirne, Turkey (Türkiye), 22130

Not Yet Recruiting

25

Ege Universitesi Tip Fakultesi

Izmir, İzmir, Turkey (Türkiye), 35040

Not Yet Recruiting

26

VM Medical Park Mersin Hastanesi

Mersin, Mersin, Turkey (Türkiye), 33200

Not Yet Recruiting

27

Sakarya Universitesi Egitim ve Arastirma Hastanesi

Adapazarı, Sakarya, Turkey (Türkiye), 54100

Not Yet Recruiting

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Research Team

A

Anna Lotti Suffredini

CONTACT

L

Linda Karpiak

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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