Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New IVIg therapy aims to boost platelets in chronic ITP patients

NCT ID NCT07059000

Disease control Sponsor: Kedrion S.p.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study tests a medicine called KIg 10 (intravenous immunoglobulin) in adults with chronic ITP, a condition where the immune system destroys platelets, causing bleeding and bruising. The goal is to see if KIg 10 can safely raise platelet counts and stop bleeding. About 40 people aged 18-70 with low platelet counts will receive the treatment and be monitored for response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, 18-70 years of age. 2. Patient has signed the ICF. 3. Diagnosis of chronic (\> 12 months duration) ITP as defined by the International Working Group. 4. 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. 5. A pre-infusion platelet count of \< 30 × 10\^9/L at the Baseline Visit. 6. Patient is willing to comply with all requirements of the protocol. 7. 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. 8. Authorization to access personal health information. Exclusion Criteria: 1. Patients incapable of giving informed consent. 2. 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). 3. Patients with Evans Syndrome. 4. Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV. 5. History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction. 6. Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients. 7. Patient unresponsive previously to IVIg or anti-D Ig treatment. 8. Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA. 9. Splenectomy within 4 weeks of the Baseline Visit or planned splenectomy throughout the study period. 10. Participants with known inherited thrombocytopenia. e.g., MYH-9 disorders. 11. Participants with myelodysplastic syndrome (MDS). 12. 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: 1. patients on a stable dose of TPO-RA within 4 weeks of the Baseline Visit 2. patients on a stable dose of Mycophenolate Mofetil within 3 months of the Baseline Visit 3. patients on stable dose of Danazol within 3 months of the Baseline Visit 4. 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 5. 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. 13. Received any blood, blood product, or blood derivative within 1 month of the Baseline Visit. 14. Received rituximab within 6 months of the Baseline Visit. 15. Had a platelet transfusion or receipt of blood products containing platelets within 7 days of Visit 1 (Day 1). 16. Received recombinant activated factor VII within 7 days of the Baseline Visit. 17. Had therapy with live attenuated virus vaccines within 3 months of the Baseline Visit. 18. Use of loop diuretics within 1 week of the Baseline Visit. 19. Patients at high risk of thrombotic events. 20. 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. 21. 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. 22. Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia. 23. Patients with hyperproteinemia, increased serum viscosity, and/or hyponatremia. 24. Severe liver or kidney disease (normal reference ranges of laboratory doing the analysis): 1. alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5x \> upper limit of normal (ULN) 2. creatinine \> 120 μmol/L 3. blood urea nitrogen (BUN) \> 2.5x ULN 25. 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. 26. Body mass index \> 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload. 27. 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. 28. 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. 29. Any condition that the Investigator believes is likely to interfere with evaluation of the IMP or with satisfactory conduct of the trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic primary immune thrombocytopenia (ITP) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autoimmune disease autoimmune thrombocytopenic purpura blood coagulation disease hematologic disorder hemorrhagic disease Purpura, Thrombocytopenic, Idiopathic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic primary immune thrombocytopenia (ITP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AULSS 8 Berica - Ospedale San Bortolo Di Vicenza

    RECRUITING

    Vicenza, Vicenza, 36100, Italy

  • Ankara Üniversitesi Tip Fakültesi - Cebeci Arastirma ve Uygulama Hastanesi

    RECRUITING

    Ankara, Ankara, 06100, Turkey (Türkiye)

  • Azienda Ospedaliero - Universitaria Careggi

    RECRUITING

    Florence, Florence, 50134, Italy

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

    RECRUITING

    Torino, Turin, 10126, Italy

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    RECRUITING

    Novara, Novara, 28100, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina

    RECRUITING

    Trieste, Trieste, 34148, Italy

  • Coltea - Spital Clinic

    RECRUITING

    Bucharest, Bucharest, 030 171, Romania

  • Complejo Asistencial Universitario de Burgos - Hospital Universitario de Burgos

    WITHDRAWN

    Burgos, Burgos, 09006, Spain

  • Complejo Hospitalario Ruber Juan Bravo

    RECRUITING

    Madrid, Madrid, 28006, Spain

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    RECRUITING

    Yenimahalle, Ankara, 06200, Turkey (Türkiye)

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Ege Universitesi Tip Fakultesi

    NOT_YET_RECRUITING

    Izmir, İzmir, 35040, Turkey (Türkiye)

  • Fakultni Nemocnice Brno

    RECRUITING

    Brno, South Moravian, 625 00, Czechia

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, Madrid, 28007, Spain

  • Instituto De Investigacion Biomedica De A Coruna - Virologia Clinica

    RECRUITING

    A Coruña, La Coruña, 15006, Spain

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    RECRUITING

    Cluj-Napoca, Cluj, 400015, Romania

  • Klinicko-Bolnicki Centar Zemun

    TERMINATED

    Belgrade, 11080, Serbia

  • Kocaeli Üniversitesi Arastirma ve Uygulama Hastanesi

    RECRUITING

    Ankara, Ankara, 06680, Turkey (Türkiye)

  • NY Cancer and Blood Specialists

    RECRUITING

    Shirley, New York, 11967, United States

  • Onkologisches Zentrum Donauwörth Neudegger - Onkomedeor Onkologische Zentren

    WITHDRAWN

    Donauwörth, Bavaria, 86609, Germany

  • Sakarya Universitesi Egitim ve Arastirma Hastanesi

    RECRUITING

    Adapazarı, Sakarya, 54100, Turkey (Türkiye)

  • Spitalul Filantropia - Craiova

    RECRUITING

    Craiova, Dolj, 200143, Romania

  • Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi

    RECRUITING

    Edirne, Edirne, 22130, Turkey (Türkiye)

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • Universitätsklinikum Frankfurt

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • Univerzitetski Klinicki Centar Srbije

    RECRUITING

    Belgrade, 11000, Serbia

  • VM Medical Park Mersin Hastanesi

    RECRUITING

    Mersin, Mersin, 33200, Turkey (Türkiye)

  • Vseobecna Fakultni Nemocnice v Praze

    RECRUITING

    Prague, Prague, 128 08, Czechia