Clinical trials: Thrombotic Microangiopathies
Bioequivalence Study in Healthy Subjects, Immune Thrombocytopenia (ITP)
Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions
This is an open-label, randomized, crossover Phase 1 study to evaluate the bioequivalence, pharmacokinetics, and safety of two oral SKI-O-703 drugs (test and reference) in healthy adults under fed conditions.
- Conditions
- Bioequivalence Study in Healthy Subjects, Immune Thrombocytopenia (ITP), Rheumatoid Arthritis (RA)
- Trial name
- NCT07675226
- Testing
- SKI-O-703 API in Capsules, SKI-O-703 Formulated Granules in Capsules
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Oscotec Inc.
Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP)
An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases
This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in…
- Conditions
- Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP), Systemic Lupus Erythematosus(SLE)
- Trial name
- NCT07174843
- Testing
- CD19/CD22/BCMA CAR-T cells(BZE2204)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Cell Therapy Group Co.,Ltd
Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenia
Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP)
This exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy
- Trial name
- NCT06287567
- Testing
- Lusutrombopag Oral Tablet
- Where
- China
- Volunteers
- 17 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Immune Thrombocytopenia
Alteration of Different Immune Parameters in Immune Thrombocytopenia （ITP） Patients Receiving Eltrombopag Treatment
This project was undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to report the alteration of Different Immune Parameters in ITP Patients Receiving Eltrombopag Treatment.
- Trial name
- NCT01864512
- Where
- China
- Sponsor
- Shandong University
Immune Thrombocytopenia
Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy
This is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus IVIg to prednisone monotherapy in the treatment of immune thrombocytopenia (ITP) in pregnancy.
- Trial name
- IVIg (NCT06577909)
- Testing
- Prednisone, IVIg
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Peking University People's Hospital
Immune Thrombocytopenia, Autoimmune Hemolytic Anemia
Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia
The Internal Medicine Department of Haut-Lévêque Hospital (Pr E LAZARO, Pr JL PELLEGRIN, Pr JF VIALLARD) was accredited in 2017 by the Ministry of Health as a Constitutive Reference Center for Autoimmune Cytopenia.
- Conditions
- Immune Thrombocytopenia, Autoimmune Hemolytic Anemia, Autoimmune Neutropenia
- Trial name
- BIOCAI (NCT04005638)
- Testing
- blood sample, urine sample
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Bordeaux
Immune Thrombocytopenia, Treatment
Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)
This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had…
- Trial name
- NCT07297563
- Testing
- Rituximab, Daratumumab
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Immune Thrombocytopenia
Low-dose Baricitinib Plus Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia
This is a prospective, multicenter, randomized, controlled phase 2 trial to compare the efficacy and safety profiles in ITP patients receiving baricitinib plus danazol to those receiving danazol alone.
- Trial name
- NCT05852847
- Testing
- Baricitinib 2 MG [Olumiant], Danazol
- Where
- 10 sites in China
- Volunteers
- 216 people
- Sponsor
- Peking University People's Hospital
Idiopathic Thrombocytopenic Purpura
Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim
The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.
- Trial name
- NCT01143038
- Testing
- Romiplostim
- Where
- 48 sites in United States, Australia and 7 more
- Volunteers
- 75 people
- Sponsor
- Amgen
Immune Thrombocytopenia (ITP)
Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.
- Trial name
- NCT02868060
- Testing
- Romiplostim
- Where
- 5 sites in China
- Volunteers
- 16 people
- Sponsor
- Kyowa Kirin China Pharmaceutical Co., Ltd.
Primary Immune Thrombocytopenia
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to assess the long-term safety, tolerability and clinical efficacy of treatment with rozanolixizumab.
- Trial name
- myOpportunITy3 (NCT04596995)
- Testing
- Rozanolixizumab
- Where
- 27 sites in United States, China and 12 more
- Volunteers
- 43 people
- Sponsor
- UCB Biopharma SRL
Immune Thrombocytopenic Purpura
Study to Evaluate Safety and Efficacy in Adult Subjects With ITP
The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.
- Trial name
- ITP (NCT02273960)
- Testing
- BMS-986004 75 mg IV, BMS-986004 225 mg IV, BMS-986004 675 mg IV
- Where
- 20 sites in United States, Australia and 6 more
- Volunteers
- 46 people
- Sponsor
- Bristol-Myers Squibb
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
Atypical Hemolytic-Uremic Syndrome
Atypical Hemolytic-Uremic Syndrome (aHUS) Registry
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.
- Trial name
- NCT01522183
- Where
- 141 sites in United States, Australia and 15 more
- Volunteers
- 3,000 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hemolytic-Uremic Syndrome, Membranoproliferative Glomerulonephritis
New Analytic Tools for aHUS and C3G Diagnosis
This protocol is part of a larger project, COMPRare (COMPlement-mediated Rare kidney diseases), which has been financed on behalf of the EJP RD (European Joint Programme on Rare Diseases) program of EU and is leaded by a…
- Conditions
- Hemolytic-Uremic Syndrome, Membranoproliferative Glomerulonephritis, Healthy
- Trial name
- COMPRare (NCT05985122)
- Testing
- C3NEF assay
- Where
- Italy
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Purpura, Idiopathic Thrombocytopenic Purpura
All-Trans Retinoic Acid (ATRA) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of All-Trans Retinoic Acid (ATRA) combining with High-dose Dexamethasone for the treatment of adults with…
- Trial name
- NCT01882127
- Testing
- All-Trans Retinoid Acid(ATRA), Dexamethasone
- Where
- China
- Sponsor
- Shandong University
Immune Thrombocytopenia
The Combination of Low-dose Rituximab and ATRA as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and ATRA in patients with steroid-resistant/relapsed ITP.
- Trial name
- NCT03304288
- Testing
- Rituximab, All-trans retinoic acid
- Where
- 4 sites in China
- Volunteers
- 168 people
- Sponsor
- Peking University People's Hospital
Thrombotic Microangiopathy, Acute Kidney Injury
French National Cohort MATRIX "Renal and Systemic Thrombotic Microangiopathy"
Thrombotic microangiopathies (TMAs) are a diverse, rare but serious group of diseases. Progress has been made regarding the epidemiology of TMA (Bayer CJASN 2019).
- Conditions
- Thrombotic Microangiopathy, Acute Kidney Injury, Hemolytic Uremic Syndrome, Nephrology
- Trial name
- MATRIX (NCT05991245)
- Testing
- Collecting datas
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Tours
Corticosteroid-resistant or Relapsed ITP
A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia
Thrombopoietin Receptor Agonists (TPO-ra) are novel treatments for patients with refractory Primary Immune Thrombocytopenia (ITP). Rh-TPO and eltrombopag increase the number of platelets through different mechanism.
- Trial name
- NCT04214951
- Testing
- Eltrombopag, Recombinant human thrombopoietin (rh-TPO)
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Peking University People's Hospital
ITP - Immune Thrombocytopenia
Multi-target Drugs Sequential Combination Therapy in Adults Patients With Newly Diagnosed Primary Immune Thrombocytopenia
This prospective, single-arm, multicenter, exploratory study will enroll 38 adults patients with newly diagnosed primary immune thrombocytopenia (ITP).
- Trial name
- NCT07788456
- Testing
- standard-dose methylprednisolone/prednisone., thrombopoietin receptor agonist(TPO-RA), including but not limited to hetrombopag or eltrombopag., rituximab.
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China