Clinical trials: Primary Immune Thrombocytopenia
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)
Study of PN20 in Adult Patients With Primary Immune Thrombocytopenia (ITP)
The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with primary immune thrombocytopenia (ITP).
- Trial name
- NCT06880081
- Testing
- PN20 treatment
- Where
- 5 sites in China
- Volunteers
- 12 people
- Sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
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
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
The main aim of the study is to evaluate the safety and efficacy of efgartigimod PH20 SC (subcutaneous) in adult patients with primary immune thrombocytopenia (ITP).
- Trial name
- ADVANCE SC+ (NCT04812925)
- Testing
- efgartigimod PH20 SC
- Where
- 83 sites in United States, Argentina and 23 more
- Volunteers
- 173 people
- Sponsor
- argenx
Primary Immune Thrombocytopenia
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP).
- Trial name
- NCT05070845
- Testing
- PF-06835375
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 61 people
- Sponsor
- Pfizer
Inherited Bone Marrow Failure Syndrome, Fanconi Anemia
Enhancing the Clinical Management of CMF Through a National Pediatric and Adult Network Based on Biological and Genetic Data
A non-profit, translational, prospective and retrospective study. Patients will be enrolled according to the procedures described in the protocol, and samples will be processed and analyzed as specified in the protocol.
- Conditions
- Inherited Bone Marrow Failure Syndrome, Fanconi Anemia, Dyskeratosis Congenita, Telomere Biology Disorder
- Trial name
- 2023-12377081 (NCT07877727)
- Where
- 4 sites in Italy
- Volunteers
- 250 people
- Sponsor
- Istituto Giannina Gaslini
Primary Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after…
- Trial name
- VAY RE-HIT (NCT07039422)
- Testing
- Ianalumab
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia
A Study of Patients' Preferences for Primary Immune Thrombocytopenia Treatment
This study aims to evaluate treatment preferences of patients with Primary Immune Thrombocytopenia (ITP) in the United States (US) by conducting a preference elicitation survey.
- Trial name
- NCT07786077
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Thrombocytopenia
A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)
This Phase 3 study is designed to evaluate the efficacy and safety of romiplostim in combination with predniso(lo)ne compared with predniso(lo)ne alone in adults with previously untreated Primary Immune Thrombocytopenia (ITP).
- Trial name
- ROMISTER (NCT07700238)
- Testing
- Romiplostim, Predniso(lo)ne
- Where
- 3 sites in United States
- Volunteers
- 126 people
- Sponsor
- Amgen
Primary Immune Thrombocytopenia
SG301-SC Injection Safety Study in Subjects With Primary ITP Patients
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study. The primary objective is to evaluate the safety and efficacy of SG301 SC Injection in participants with ITP, while the secondary…
- Trial name
- NCT07710248
- Testing
- low dose group, high dose group
- Where
- 22 sites in China
- Volunteers
- 60 people
- Sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
Primary Immune Thrombocytopenia
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with…
- Trial name
- VAYHIT2 (NCT05653219)
- Testing
- Ianalumab, Eltrombopag
- Where
- 74 sites in United States, Argentina and 22 more
- Volunteers
- 152 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)
Phase III Study on HMPL-523 for Treatment of ITP
The purpose of this study is to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP).
- Trial name
- NCT05029635
- Testing
- HMPL-523
- Where
- 37 sites in China
- Volunteers
- 272 people
- Sponsor
- Hutchmed
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