Clinical trials: Primary Immune Thrombocytopenia (ITP), active
Chronic Primary Immune Thrombocytopenia (ITP)
A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults 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
- Trial name
- ITP (NCT07059000)
- Testing
- Kedrion IVIG 10%
- Where
- 28 sites in United States, Czechia and 6 more
- Volunteers
- 40 people
- Sponsor
- Kedrion S.p.A.
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who…
- Trial name
- VAY2EXPLORE (NCT07421167)
- Testing
- ianalumab, thrombopoietin receptor agonist (TPO-RA)
- Where
- 19 sites in United States
- Volunteers
- 164 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia (ITP)
A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies
The purpose of this study is to evaluate the therapeutic efficacy, safety and tolerability of ianalumab in adult patients with primary ITP previously treated with at least one corticosteroid and one TPO-RA.
- Trial name
- NCT05885555
- Testing
- Ianalumab
- Where
- 24 sites in United States, Argentina and 11 more
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia (ITP)
A Phase Ib/II Clinical Trial of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)
A randomized, double-blind, placebo-controlled design was designed to evaluate the safety and tolerability, pharmacokinetic/pharmacodynamic profile, and immunogenicity of multiple administration of STSA-1301 subcutaneous…
- Trial name
- NCT06929299
- Testing
- STSA-1301 subcutaneous injection
- Where
- 7 sites in China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Jiangsu BioJeTay Biotechnology Co., Ltd.
Primary Immune Thrombocytopenia (ITP)
rhTPO Dose Escalation vs Eltrombopag Switch in ITP
This study is a prospective, multicenter, randomized controlled study, planning to enroll 110 ITP patients who failed to respond to conventional-dose rhTPO (300 IU/kg/d) after 14 days of treatment (PLT < 30×10⁹/L).
- Trial name
- NCT07476846
- Testing
- Recombinant Human Thrombopoietin（rhTPO）, Eltrombopag PfOS
- Volunteers
- 112 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Primary Immune Thrombocytopenia (ITP)
A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.
The purpose of this study is to assess the efficacy, safety and pharmacokinetics (PK) of ianalumab (VAY736) in addition to eltrombopag treatment; and to inform the dose of ianalumab in pediatric patients (5 to <18 years of age)…
- Trial name
- VAYHIT-P (NCT07660172)
- Testing
- Ianalumab, Eltrombopag
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia (ITP)
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in increasing the rate of stable response off treatment at 12 months (SROT-12) in…
- Trial name
- VAYHIT1 (NCT05653349)
- Testing
- Ianalumab, Corticosteroids
- Where
- 111 sites in United States, Argentina and 23 more
- Volunteers
- 226 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia (ITP)
A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP).
- Trial name
- advance NEXT (NCT06544499)
- Testing
- Efgartigimod IV
- Where
- 94 sites in United States, Austria and 15 more
- Volunteers
- 69 people
- Sponsor
- argenx
Primary Immune Thrombocytopenia (ITP)
High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia
This is a randomized controlled study of high-dose Dexamethasone combined with Orelabrutinib versus high-dose Dexamethasone combined with placebo in adult patients with newly diagnosed Primary Immune Thrombocytopenia.
- Trial name
- NCT07559331
- Testing
- High-Dose Dexamethasone Combined with Orelabrutinib
- Where
- China
- Volunteers
- 86 people
- Sponsor
- Shandong University
Primary Immune Thrombocytopenia (ITP)
Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults
This multicenter randomized, open-label study aimed to compare the efficacy and safety of eltrombopag combining rituximab with eltrombopag in China adult ITP patients .This study was be conducted in adult ITP patients who had not…
- Trial name
- NCT04518475
- Testing
- eltrombopag combining rituximab, eltrombopag
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Primary Immune Thrombocytopenia (ITP)
An Open-label Study of Intravenous Immunoglobulin (5%) for the Treatment of Primary Immune Thrombocytopenia
It is a clinical trial of a medicinal product Human Immunoglobulin for Intravenous Injection (5%) manufactured by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. (hereinafter referred to as 5% IVIG).
- Trial name
- NCT07233213
- Testing
- Human immunoglobulin (pH4) for intravenous injection
- Where
- 9 sites in Turkey (Türkiye)
- Volunteers
- 36 people
- Sponsor
- Grand Shuyang Life Sciences (Chengdu) Co., Ltd.
Primary Immune Thrombocytopenia (ITP)
Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy
To evaluate whether orelabrutinib combined with romiplostim N01 can improve the quality of remission, increase the probability of successful drug withdrawal, and prolong the time to treatment failure in patients with primary…
- Trial name
- ORBIT (NCT07400250)
- Testing
- Orelabrutinib, Romiplostim N01
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Peking Union Medical College Hospital
Primary Immune Thrombocytopenia (ITP)
Sequential rhTPO and Eltrombopag Following Glucocorticoids for Severe Adult ITP
To address the clinical need for improving early response rates, maintaining sustained responses, reducing relapse rates, and minimizing adverse events in the treatment of immune thrombocytopenia (ITP), the investigators…
- Trial name
- NCT07189910
- Testing
- Eltrombopag
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM)
Safety Study of CC312 in Autoimmune Disease Patients
This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune…
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA)
- Trial name
- NCT06888960
- Testing
- CC312
- Where
- China
- Volunteers
- 18 people
- Sponsor
- CytoCares Inc
Primary Immune Thrombocytopenia (ITP)
A PHASE II TRIAL AIMING TO INVESTIGATE THE SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN IN ADULT PATIENTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA PREVIOUSLY TREATED WITH A THROMBOPOIETIN RECEPTOR AGONIST AND/OR RITUXIMAB AFTER CORTICOSTEROID FIRST-LINE THERAPY
This is a Phase II open label, prospective, multicenter trial designed to assess the safety and clinical activity of belantamab mafodotin in adult patients with primary immune thrombocytopenia (ITP) previously treated with a…
- Trial name
- BONSAI (NCT07019545)
- Testing
- Belantamab Mafodotin, Dexamethasone
- Where
- Greece
- Volunteers
- 14 people
- Sponsor
- Hellenic Society of Hematology
Primary Immune Thrombocytopenia (ITP)
Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial
This prospective, multicenter, randomized study aim to evaluate the efficacy and safety of romiplostim N01 combined with glucocorticoids as the first-line treatment for newly diagnosed adult primary immune thrombocytopenia (ITP).
- Trial name
- NCT06992128
- Testing
- Romiplostim N01 combined with dexamethasone, Dexamethasone monotherapy
- Where
- China
- Volunteers
- 129 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
ITP - Immune Thrombocytopenia, Primary Immune Thrombocytopenia (ITP)
RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia
Primary immune thrombocytopenia (PIT), previously referred to as idiopathic thrombocytopenic purpura, is an acquired disease characterized by accelerated platelet destruction and deficient platelet production by megakaryocytes.
- Trial name
- RESTI (NCT06919341)
- Where
- 36 sites in Spain
- Volunteers
- 1,000 people
- Sponsor
- Fundación Española de Hematología y Hemoterapía
Primary Immune Thrombocytopenia (ITP)
Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia
Primary immune thrombocytopenia (ITP) is an autoimmune disease mainly mediated by autoreactive B cells and the presence of pathogenic anti-platelet auto-antibodies that enhance platelet destruction and impair platelet production.
- Trial name
- RITUX-PLUS 2 (NCT05338190)
- Testing
- Combination of Rituximab with subcutaneous belimumab
- Where
- France
- Volunteers
- 132 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris