The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03951623|
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : June 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenia (ITP)||Drug: HMPL-523 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523, a Syk Inhibitor in Adult Patients of Immune Thrombocytopenia: a Randomized, Double Blinded, Placebo Controlled Phase Ib Study|
|Actual Study Start Date :||May 30, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Active Comparator: treatment arm
Eligible subjects will be treated with planned dose of 100 mg, 200 mg and 300 mg HMPL-523 once daily for 8 weeks.
HMPL-523 will be oral administrated once daily for 8 weeks.
Placebo Comparator: placebo arm
Eligible subjects will be treated with HMPL-523 matching placebo once daily for 8 weeks.
HMPL-523 matching placebo will be oral administrated once daily for 8 weeks.
- Number of Participants with any Adverse Event [ Time Frame: From first dose to within 28 days after the last dose ]Adverse Events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
- Maximum plasma concentration (Cmax) [ Time Frame: Day 15, 16, 29, 43 and 47 in dose escalation phase and Day 15, 29, 43 and 57 in dose expansion phase ]Maximum plasma concentration (Cmax)
- Area under the concentration-time curve in a selected time interval (AUC0-t) [ Time Frame: Day 15, 16, 29, 43 and 47 in dose escalation phase and Day 15, 29, 43 and 57 in dose expansion phase ]Area under the concentration-time curve in a selected time interval (AUC0-t)
- Rate of Clinical Remission [ Time Frame: Day 1 to 8 weeks treatment ]Rate of Clinical Remission was defined as the proportion of patients who have platelet ≥30×10^9/L at week 8 and increased ≥20×10^9/L vs baseline without anti-ITP emergency treatment during the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951623
|Contact: jiayi Mai||086-021-20673063||Jiayim@hmplglobal.com|
|Blood diseases hospital, Chinese academy of medical university||Recruiting|
|Tianjin, Tianjin, China, 300000|
|Contact: Renchi Yang firstname.lastname@example.org|
|Study Director:||Rongjun Liu||Hutchison MediPharma|