Clinical trials: Persistent Thrombocytopenia
Drug Effect, Safety Issues
Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 (GEROPHARM, Russia) in comparison with the drug Nplate® (Amgen, the Netherlands). the main questions are 1.
- Conditions
- Drug Effect, Safety Issues, Immunogenicity
- Trial name
- NCT06497036
- Testing
- GP404141, Nplate
- Where
- 6 sites in Russia
- Volunteers
- 160 people
- Sponsor
- Geropharm
Immune Thrombocytopenic Purpura
A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
- Trial name
- FIT (NCT02076399)
- Testing
- Fostamatinib disodium
- Where
- 52 sites in United States, Australia and 6 more
- Volunteers
- 76 people
- Sponsor
- Rigel Pharmaceuticals
Immune Thrombocytopenia
PRTX-100-203 Open-Label, Dose Escalation Study in Adult Patients With ITP
Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may lead to improved platelet levels where these are decreased due to immunological pathologies and that PRTX-100 has an acceptable safety…
- Trial name
- NCT02566603
- Testing
- PRTX-100
- Where
- 16 sites in France, United Kingdom
- Volunteers
- 15 people
- Sponsor
- Protalex, Inc.
Immune Thrombocytopenia
Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP)
Study in patients with persistent and chronic Immune Thrombocytopenia (ITP), who have failed to respond or relapsed after prior therapy, with a platelet count <30,000/µL.
- Trial name
- NCT04056195
- Testing
- SKI-O-703
- Where
- 27 sites in United States, Greece and 3 more
- Volunteers
- 61 people
- Sponsor
- Oscotec Inc.
Immune Thrombocytopenia
Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
This was a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in…
- Trial name
- LUNA 3 (NCT04562766)
- Testing
- Rilzabrutinib
- Where
- 155 sites in United States, Argentina and 24 more
- Volunteers
- 232 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Immune Thrombocytopenia
Efficacy and Safety Assessment of a Treatment Combining Rituximab and Belimumab in Adults With Persistent Immune Thrombocytopenia
Previous studies have shown that increase level of BAFF could promote the settlement of long-lived plasma cells in the spleen of ITP patients treated with anti-CD20.
- Trial name
- RITUX PLUS (NCT03154385)
- Testing
- Rituximab (Mabthera ®) Belimumab (Benlysta ®)
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Idiopathic Thrombocytopenic Purpura
The Effect of Eltrombopag on the Expression of Platelet Collagen Receptor GPVI in Pediatric ITP.
Using eltronmobag as an alternative pathway, which depend on stimulation of thrombocyte synthesis, in chronic and persistent immune thrombocytopenia may be more promising treatment than the classic type, not only by increasing…
- Trial name
- NCT03412188
- Testing
- Eltrombopag, conventional
- Where
- Egypt
- Volunteers
- 36 people
- Sponsor
- Nayera Hazaa Elsherif
Primary Immune Thrombocytopenia
A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia…
- Trial name
- myOpportunITy1 (NCT04200456)
- Testing
- Rozanolixizumab
- Where
- 29 sites in United States, Bulgaria and 14 more
- Volunteers
- 33 people
- Sponsor
- UCB Biopharma SRL
Persistent Immune Thrombocytopenia
Management of Children With Persistent ITP, A Novel Approach
The goal of this clinical trial is to learn if mini-pool intravenous immunoglobulin (IVIG) is a safe and effective treatment for children with persistent immune thrombocytopenia (ITP).
- Trial name
- LMICs (NCT07068126)
- Testing
- Mini-Pool IVIG
- Where
- 3 sites in Egypt
- Volunteers
- 20 people
- Sponsor
- Assiut University
Persistent Isolated Chemotherapy-Induced Thrombocytopenia, Chemotherapy-Induced Thrombocytopenia
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors
This is a prospective, randomized, open-label, active-controlled study to evaluate the efficacy and safety of Romiplostim N01 plus all-trans retinoic acid (ATRA) compared with Romiplostim N01 alone in adults with persistent…
- Conditions
- Persistent Isolated Chemotherapy-Induced Thrombocytopenia, Chemotherapy-Induced Thrombocytopenia, Gynecologic Cancers, Ovarian Cancer
- Trial name
- N01-A-PICIT-GT (NCT07586826)
- Testing
- Romiplostim N01, All-trans retinoic acid
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Peking University People's Hospital
Primary Immune Thrombocytopenia
A Study on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults
This study is an extension of the TQB3473-III-01 study, aimed at evaluating the safety and efficacy of TQB3473 tablets in adult patients with persistent or chronic ITP who have received at least one ITP standard treatment that is…
- Trial name
- NCT07083739
- Testing
- TQB3473 Tablets
- Where
- 51 sites in China
- Volunteers
- 320 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Persistent Thrombocytopenia, Allogeneic Hematopoietic Stem Cell Transplantation
Baricitinib for Post-HSCT Persistent Thrombocytopenia
This is a prospective, open-label phase 1b/2 clinical trial to explore the safety and efficacy profiles of baricitinib in patients with thrombopoietin-receptor-agonist-refractory persistent thrombocytopenia after allogeneic…
- Trial name
- BAPT (NCT07535645)
- Testing
- Baricitinib
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Peking University People's Hospital
Immune Thrombocytopenia (ITP)
A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)
Primary Objective: To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP) Secondary Objectives: To assess the safety and tolerability of…
- Trial name
- NCT04669600
- Testing
- SAR445088 (BIVV020)
- Where
- 9 sites in United States, Czechia and 4 more
- Volunteers
- 12 people
- Sponsor
- Bioverativ, a Sanofi company
Immune Thrombocytopenic Purpura
Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP
C-935788-055 is an open-label, multi-center, expanded access (EAP) study.
- Trial name
- NCT03363334
- Testing
- Fostamatinib disodium 100 mg, Fostamatinib disodium 150 mg
- Sponsor
- Rigel Pharmaceuticals
Immune Thrombocytopenia
Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)
The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut subjects with persistent or chronic primary immune thrombocytopenia (ITP).
- Trial name
- NCT02868099
- Testing
- Romiplostim
- Where
- China
- Volunteers
- 203 people
- Sponsor
- Kyowa Kirin China Pharmaceutical Co., Ltd.
Primary Immune Thrombocytopenia
A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia
Primary immune thrombocytopenia (ITP) is a rare disease that results in low levels of platelets - the cells that help blood clot.
- Trial name
- NCT04278924
- Testing
- TAK-079
- Where
- 55 sites in United States, Bulgaria and 9 more
- Volunteers
- 41 people
- Sponsor
- Takeda
Immune Thrombocytopenia
Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia
Individuals with immune thrombocytopenia (ITP) frequently report difficulties with attention and memory. The main question this study seeks to answer is: Do patients with ITP have evidence of cognitive impairment as detected by a…
- Trial name
- COGFIT (NCT06817395)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
Primary Immune Thrombocytopenia
A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia
The study is designed to be a randomized, open, multi-center, phase IIa/IIb seamless adaptive trial. Phase IIa: The study consists of a screening period, a core treatment period, an open label extension period, and a safety…
- Trial name
- NCT05232149
- Testing
- Orelabrutinib( lower dose), Orelabrutinib( higher dose)
- Where
- 9 sites in China
- Volunteers
- 30 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Immune Thrombocytopenia
End of EXTEND: Discontinuation of Medication for Patients With Immune Thrombocytopenia
This study proposes to observe whether a stable platelet count would be maintained without additional treatment in the long term in at least a proportion of patients who have discontinued eltrombopag taken for at least 4 months.
- Trial name
- NCT01386723
- Testing
- Discontinuation of eltrombopag
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Weill Medical College of Cornell University
Immune Thrombocytopenia
An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)
The primary objective of this study was to assess the long-term safety of lusutrombopag in the treatment of adults with relapsed persistent or chronic ITP with or without prior splenectomy.
- Trial name
- NCT01129024
- Testing
- Lusutrombopag
- Where
- 19 sites in United States
- Volunteers
- 19 people
- Sponsor
- Shionogi