Hemorrhage Clinical Trial
Official title:
A Multicenter, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523, a Syk Inhibitor, in Adult Subjects With Immune Thrombocytopenia
This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.
This study is a Phase 1b, open-label, multicenter, single-arm study to evaluate the safety, tolerability, and preliminary efficacy of HMPL-523 in adult subjects with primary ITP diagnosed at least 3 months prior to enrollment or randomization. In the dose escalation stage (Part 1), subjects will receive one of 3 dose levels of HMPL-523 to determine the recommended dose of HMPL-523 for the randomized dose optimization- stage (Part 2). At the end of Part 1, 2 dose levels will be selected to be used in the dose-optimization stage (Part 2) of the study. In Part 2 of the study, subjects will be randomized in a 1:1 ratio between the 2 dose levels to better understand the exposure/efficacy/toxicity relationship. At the end of Part 2, the Recommended Phase 3 dose (RP3D) of HMPL-523 will be determined based on the safety, efficacy and PK data. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02815670 -
Reversal Dabigatran Anticoagulant Effect With Idarucizumab
|
Phase 3 | |
| Completed |
NCT04588350 -
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
|
N/A | |
| Recruiting |
NCT02972385 -
Pharmacogenomics of Warfarin in Hispanics and Latinos
|
||
| Completed |
NCT02569606 -
Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
|
||
| Completed |
NCT02554006 -
Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings
|
N/A | |
| Recruiting |
NCT02446730 -
Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome
|
Phase 4 | |
| Completed |
NCT01935427 -
Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume
|
N/A | |
| Completed |
NCT01955720 -
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
|
Phase 1 | |
| Recruiting |
NCT01709786 -
Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage
|
N/A | |
| Completed |
NCT01191554 -
Dose-ranging Study of Tranexamic Acid in Valve Surgery
|
N/A | |
| Completed |
NCT01136590 -
Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
|
Phase 4 | |
| Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A | |
| Completed |
NCT01085006 -
The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery
|
Phase 1/Phase 2 | |
| Completed |
NCT00700141 -
Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®
|
N/A | |
| Completed |
NCT00375466 -
Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.
|
N/A | |
| Completed |
NCT00147420 -
RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet
|
N/A | |
| Completed |
NCT00479362 -
Anticoagulant Therapy During Pacemaker Implantation
|
Phase 4 | |
| Recruiting |
NCT05945680 -
Tranexamic Acid in Breast Esthetic Surgery.
|
Phase 4 | |
| Completed |
NCT03273322 -
Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure
|
Phase 2/Phase 3 | |
| Withdrawn |
NCT05672407 -
The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery
|
Phase 4 |