Actively Recruiting
A Phase III, Open-label, Single Arm, Prospective, Multicenter Study to Assess Efficacy and Safety of Kedrion Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia
Led by Kedrion S.p.A. · Updated on 2026-03-13
40
Participants Needed
27
Research Sites
N/A
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
Researchers are evaluating the effectiveness and safety of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in adults with chronic primary Immune Thrombocytopenia (ITP), a condition characterized by a low platelet count lasting more than 12 months. This Phase III, open-label, single-arm study focuses on adult patients aged 18 to 70 years who have chronic primary ITP with platelet counts below 30 × 10^9/L. The study is sponsored by Kedrion S.p.A. and aims to assess how well the treatment increases platelet counts and controls bleeding symptoms. Participants will receive a single treatment course of Kedrion IVIg 10% at a dose of 2 g/kg, administered intravenously over two days. The treatment period is followed by monitoring to evaluate the platelet count response and bleeding regression. The study does not include a control group or placebo, and all subjects receive the same investigational treatment. The treatment is administered at the start of the study, with follow-up visits extending up to 30 days after treatment. During the study, participants will undergo platelet count assessments and evaluation of bleeding symptoms from the start of treatment (Day 1) through to the end of the study (Day 30). Researchers will monitor the rate and duration of platelet response, complete response rates, and safety and tolerability of the treatment. The primary outcome is the rate of subjects who respond by Day 14. Additional assessments include time to response, duration of response, regression of hemorrhages, and safety monitoring throughout the 30-day period. Participants' health information will be accessed with authorization, and adherence to the protocol is required throughout the study.
CONDITIONS
Brief Title
A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
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 (more than 12 months) primary Immune Thrombocytopenia (ITP)
- Mean screening platelet count below 30 × 10^9/L from two counts at least one day apart
- Platelet count below 30 × 10^9/L at Baseline Visit
- Willingness to comply with all protocol requirements
- Negative pregnancy test for women of childbearing potential and agreement to use birth control
- Authorization to access personal health information
You will not qualify if you...
- Secondary ITP or immune-mediated thrombocytopenia other than primary ITP
- Evans Syndrome
- Infection with hepatitis B, hepatitis C, or HIV
- History of thrombotic events such as deep vein thrombosis, stroke, or myocardial infarction
- Hypersensitivity to IVIg or its components
- Previous unresponsiveness to IVIg or anti-D Ig treatment
- Known Immunoglobulin A deficiency with antibodies against IgA
- Recent or planned splenectomy within the study period
- Known inherited thrombocytopenia or myelodysplastic syndrome
- Recent use of certain immunosuppressive or platelet-enhancing drugs except stable doses of some listed medications
- Recent blood or platelet transfusions or recombinant activated factor VII
- Recent live attenuated virus vaccinations
- Use of loop diuretics within 1 week of Baseline Visit
- High risk of thrombotic events or uncontrolled hypertension
- Significant heart disease or conditions increasing blood viscosity
- Severe protein losing enteropathy, nephrotic syndrome, or lymphangiectasia
- Hyperproteinemia, increased serum viscosity, or hyponatremia
- Severe liver or kidney disease beyond specified laboratory limits
- Signs of severe anemia or hemodynamic instability
- Body mass index over 40 kg/m2 or risk of fluid overload with IVIg dose
- History of malignant disease within 3 years except certain skin or cervical cancers
- Participation in another interventional study within 30 days
- Any condition interfering with study evaluation or conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 days
Participants receive one course of treatment with 2 g/kg of Kedrion IVIg 10% administered intravenously over 2 days.
1 visit (in-person) for treatment administration
Duration - Up to 30 days after treatment
Participants are monitored for safety, platelet count response, and hemorrhage regression up to 30 days after treatment.
Approximately 3 visits for post-treatment assessments
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
Research Team
A
Anna Lotti Suffredini
L
Linda Karpiak
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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