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

NCT07059000 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: KB0722023-507115-35-00
• Study Type: interventional
• Target: 40
• Locations: 8 countries
• Sites: 27

Brief 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)

Keywords

ITP; Primary Immune Thrombocytopenia; Autoimmune Disease; Hemorrhagic Disorders; Hematologic Diseases; Blood Coagulation Disorders

Outcome Measures

Primary Outcomes (1)

• Rate of subjects with response (R)

  Assess the responder rate by measuring the platelet count increase according to the Response (R) definition and the absence of bleeding during the evaluation period

  Treatment to day 14

Secondary Outcomes (6)

• Number and rate of subjects with complete response (CR)

  Treatment to day 14

• Time to platelet count response

  Treatment to day 14

• Duration of response

  14 days after treatment to end of study

• Regression of hemorrhages

  Day 1 (Visit 1) to Day 30 (End of Study Visit)

• Platelet count assessment

  Day 1 (Visit 1) to Day 30 (End of Study Visit)

Study Arms (1)

2 g/kg Kedrion IVIg 10%

EXPERIMENTAL

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

Biological: Kedrion IVIG 10%

Interventions

Kedrion IVIG 10% BIOLOGICAL

(Intravenous) Human Normal Immunoglobulin (IVIg) 10%

Also known as: KIg 10

2 g/kg Kedrion IVIg 10%

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-70 years of age.
• Patient and/or legal authorized representative has signed the ICF.
• Diagnosis of chronic (\> 12 months duration) ITP as defined by the International Working Group.
• Mean screening platelet count of \< 30 × 10\^9/L from two qualifying counts measured at least one calendar day apart. The first qualifying count can be from historical data if measured within 14 days prior to the first KIg10 infusion. The second qualifying count will be measured within 7 days before the first KIg10 infusion.
• Platelet count of \< 30 × 10\^9/L at the Baseline Visit.
• Patient is willing to comply with all requirements of the protocol.
• Women of childbearing potential must have a negative urine pregnancy test at screening and agree to employ adequate birth control measures during the study.
• Authorization to access personal health information.

You may not qualify if:

• Patients with secondary ITP (all forms of immune-mediated thrombocytopenia except primary ITP). e.g., lupus erythematosus, rheumatoid arthritis, drug-related ITP, and Human Immunodeficiency Virus (HIV).
• Patients with Evans Syndrome.
• Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV.
• History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.
• Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients.
• Patient unresponsive previously to IVIg or anti-D Ig treatment.
• Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA.
• Splenectomy within 4 weeks of the Baseline Visit or planned splenectomy throughout the study period.
• Subjects with known inherited thrombocytopenia. e.g., MYH-9 disorders.
• Subjects with myelodysplastic syndrome (MDS).
• Administration of IVIg, anti-D immunoglobulin, mercaptopurine, vinca alkaloid, or platelet enhancing drugs (including thrombopoietin receptor agonists \[TPO-RA\], immunosuppressive, or other immunomodulatory drugs) within 3 weeks of the Baseline Visit, except for:
• patients on a stable dose of TPO-RA within 4 weeks of the Baseline Visit
• patients on a stable dose of Mycophenolate Mofetil within 3 months of the Baseline Visit
• patients on stable dose of Danazol within 3 months of the Baseline Visit
• long-term corticosteroid therapy for ITP, when the dose had been stable within 3 weeks of the Baseline Visit and no dosage change was planned until the EOS Visit

Sponsors & Collaborators

• Kedrion S.p.A.: lead
• ICON plc: collaborator

Study Sites (27)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

Vseobecna Fakultni Nemocnice v Praze

Prague, Prague, 128 08, Czechia

RECRUITING

Fakultni Nemocnice Brno

Brno, South Moravian, 625 00, Czechia

RECRUITING

Onkologisches Zentrum Donauwörth Neudegger - Onkomedeor Onkologische Zentren

Donauwörth, Bavaria, 86609, Germany

WITHDRAWN

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Azienda Ospedaliero - Universitaria Careggi

Florence, Florence, 50134, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Novara, Novara, 28100, Italy

RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, Trieste, 34148, Italy

RECRUITING

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

Torino, Turin, 10126, Italy

RECRUITING

AULSS 8 Berica - Ospedale San Bortolo Di Vicenza

Vicenza, Vicenza, 36100, Italy

RECRUITING

Coltea - Spital Clinic

Bucharest, București, 030 171, Romania

RECRUITING

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, Cluj, 400015, Romania

RECRUITING

Spitalul Filantropia - Craiova

Craiova, Dolj, 200143, Romania

RECRUITING

Univerzitetski Klinicki Centar Srbije

Belgrade, 11000, Serbia

RECRUITING

Klinicko-Bolnicki Centar Zemun

Belgrade, 11080, Serbia

RECRUITING

Complejo Asistencial Universitario de Burgos - Hospital Universitario de Burgos

Burgos, Burgos, 09006, Spain

WITHDRAWN

Instituto De Investigacion Biomedica De A Coruna - Virologia Clinica

A Coruña, La Coruña, 15006, Spain

RECRUITING

Complejo Hospitalario Ruber Juan Bravo

Madrid, Madrid, 28006, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Ankara Üniversitesi Tip Fakültesi - Cebeci Arastirma ve Uygulama Hastanesi

Ankara, Ankara, 06100, Turkey (Türkiye)

NOT YET RECRUITING

Kocaeli Üniversitesi Arastirma ve Uygulama Hastanesi

Ankara, Ankara, 06680, Turkey (Türkiye)

NOT YET RECRUITING

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Yenimahalle, Ankara, 06200, Turkey (Türkiye)

NOT YET RECRUITING

Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi

Edirne, Edirne, 22130, Turkey (Türkiye)

NOT YET RECRUITING

Ege Universitesi Tip Fakultesi

Izmir, İzmir, 35040, Turkey (Türkiye)

NOT YET RECRUITING

VM Medical Park Mersin Hastanesi

Mersin, Mersin, 33200, Turkey (Türkiye)

NOT YET RECRUITING

Sakarya Universitesi Egitim ve Arastirma Hastanesi

Adapazarı, Sakarya, 54100, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Autoimmune Diseases; Hemorrhagic Disorders; Hematologic Diseases; Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Mirella Calcinai, MD

  Kedrion S.p.A.

  STUDY DIRECTOR

Central Study Contacts

Anna Lotti Suffredini

CONTACT

+39 338 6827568; a.lotti@kedrion.com

Linda Karpiak

CONTACT

973-216-0484; l.karpiak@kedrion.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 10, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); CZ (2); TU (7); ES (4); IT (5); RO (3); DE (2); US (2)