Chronic Primary Immune Thrombocytopenia (ITP)Phase 3ITPNCT07059000
A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)
A Phase 3 study testing Kedrion IVIG 10% in people with Chronic Primary Immune Thrombocytopenia (ITP), run by Kedrion S.p.A. at 28 sites in 8 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Primary Immune Thrombocytopenia (ITP)
- What is being tested?
- Kedrion IVIG 10%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 13 Aug 2025to Jan 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-70 years of age.
- Patient 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 7 days prior to screening. The second qualifying count will be measured within 7 days before the first KIg10 infusion.
- A pre-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 (WOCBP) 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.
Who cannot join
- Patients incapable of giving informed consent.
- 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.
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- 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.
- Participants with known inherited thrombocytopenia. e.g., MYH-9 disorders.
- Participants 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
- long-term azathioprine, cyclophosphamide, or attenuated androgen therapy when the dose had been stable within 3 months of the Baseline Visit, and no dosage change was planned until after study completion. Treatment with any other products licensed for primary chronic ITP is also exclusive. An appropriate wash-out period must be determined in case of patients who might be eligible for treatment with IVIg.
- Received any blood, blood product, or blood derivative within 1 month of the Baseline Visit.
- Received rituximab within 6 months of the Baseline Visit.
- Had a platelet transfusion or receipt of blood products containing platelets within 7 days of Visit 1 (Day 1).
- Received recombinant activated factor VII within 7 days of the Baseline Visit.
- Had therapy with live attenuated virus vaccines within 3 months of the Baseline Visit.
- Use of loop diuretics within 1 week of the Baseline Visit.
- Patients at high risk of thrombotic events.
- Uncontrolled hypertension [i.e., diastolic blood pressure >100 mmHg and/or systolic blood pressure >160 mmHg]. If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.
- Congestive heart failure as per New York Heart Association III/IV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity.
- Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.
- Patients with hyperproteinemia, increased serum viscosity, and/or hyponatremia.
- Severe liver or kidney disease (normal reference ranges of laboratory doing the analysis):
- alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5x > upper limit of normal (ULN)
- creatinine > 120 μmol/L
- blood urea nitrogen (BUN) > 2.5x ULN
- Signs of severe anemia: Hemoglobin of less than 7 g/dL, hemodynamically unstable due to active bleeding, and/or when evidence of end-organ ischemia secondary to severe anemia is present.
- Body mass index > 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload.
- History of a malignant disease within 3 years of the Baseline Visit other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin.
- Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit or within 5 half-lives of the investigational medicinal product (IMP) under investigation.
- Any condition that the Investigator believes is likely to interfere with evaluation of the IMP or with satisfactory conduct of the trial.
Trial locations and contacts
28 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 8 countries
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Sakarya Universitesi Egitim ve Arastirma Hastanesi
Adapazarı, Sakarya, 54100
- Recruiting
Ankara Üniversitesi Tip Fakültesi - Cebeci Arastirma ve Uygulama Hastanesi
Ankara, Ankara, 06100
- Recruiting
Kocaeli Üniversitesi Arastirma ve Uygulama Hastanesi
Ankara, Ankara, 06680
- Recruiting
Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi
Edirne, Edirne, 22130
- Recruiting
Ege Universitesi Tip Fakultesi
Izmir, İzmir, 35040
- Recruiting
VM Medical Park Mersin Hastanesi
Mersin, Mersin, 33200
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Yenimahalle, Ankara, 06200
Italy5 sites, 5 recruiting
- Recruiting
Azienda Ospedaliero - Universitaria Careggi
Florence, Florence, 50134
- Recruiting
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Novara, 28100
- Recruiting
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Turin, 10126
- Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Trieste, 34148
- Recruiting
AULSS 8 Berica - Ospedale San Bortolo Di Vicenza
Vicenza, Vicenza, 36100
Spain4 sites, 3 recruiting
- Recruiting
Instituto De Investigacion Biomedica De A Coruna - Virologia Clinica
A Coruña, La Coruña, 15006
- Withdrawn
Complejo Asistencial Universitario de Burgos - Hospital Universitario de Burgos
Burgos, Burgos, 09006
- Recruiting
Complejo Hospitalario Ruber Juan Bravo
Madrid, Madrid, 28006
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
United States3 sites, 3 recruiting
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
- Recruiting
University of Southern California
Los Angeles, California, 90033
- Recruiting
NY Cancer and Blood Specialists
Shirley, New York, 11967
Romania3 sites, 3 recruiting
- Recruiting
Coltea - Spital Clinic
Bucharest, Bucharest, 030 171
- Recruiting
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj, 400015
- Recruiting
Spitalul Filantropia - Craiova
Craiova, Dolj, 200143
Czechia2 sites, 2 recruiting
- Recruiting
Fakultni Nemocnice Brno
Brno, South Moravian, 625 00
- Recruiting
Vseobecna Fakultni Nemocnice v Praze
Prague, Prague, 128 08
Germany2 sites, 1 recruiting
- Withdrawn
Onkologisches Zentrum Donauwörth Neudegger - Onkomedeor Onkologische Zentren
Donauwörth, Bavaria, 86609
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590
Serbia2 sites, 1 recruiting
- Recruiting
Univerzitetski Klinicki Centar Srbije
Belgrade, 11000
- Terminated
Klinicko-Bolnicki Centar Zemun
Belgrade, 11080
About this study
Official title: A Phase III, Open-label, Single Arm, Prospective, Multicenter Study to Assess Efficacy and Safety of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Adult Patients With Chronic Immune Thrombocytopenia (ITP)
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
- Being tested
- Kedrion IVIG 10%
- Keywords
- ITP, Primary Immune Thrombocytopenia, Autoimmune Disease, Hemorrhagic Disorders, Hematologic Diseases, Blood Coagulation Disorders
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Autoimmune Diseases, Hemorrhagic Disorders, Hematologic Diseases, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kedrion IVIG 10%Biological
Also called KIg 10
(Intravenous) Human Normal Immunoglobulin (IVIg) 10%
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Kedrion IVIG 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Treatment to day 14
Secondary outcomes (6)
Number and rate of subjects with complete response (CR)
Assess the clinical response rate by measuring the platelet count increase and absence of bleeding according to the Complete Response (CR)
Measured: Treatment to day 14
Time to platelet count response
Assess the time from starting treatment to time of achievement of CR or R
Measured: Treatment to day 14
Duration of response
Measured from achievement of CR or R to loss of CR or R
Measured: 14 days after treatment to end of study
Regression of hemorrhages
Time to stop bleedings
Measured: Day 1 (Visit 1) to Day 30 (End of Study Visit)
Platelet count assessment
Assess the maximum platelet count and time to achieve the maximum platelet count
Measured: Day 1 (Visit 1) to Day 30 (End of Study Visit)
Assess safety and tolerability
Number and percentage of all adverse events (AEs) and serious adverse events (SAEs)
Measured: Day 1 (Visit 1) to Day 30 (End of Study Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start13 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Primary Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kedrion S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mirella Calcinai, MD, Study director, Kedrion S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059000
- Sponsor's protocol ID
- KB072
- Other IDs
- 2023-507115-35-00, 2023
- Acronym
- ITP
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Publishing of data and IPD that underlie results in the publication will be determined at study completion to comply with ICJME minimum requirements.