Phase III Study on HMPL-523 for Treatment of ITP
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05029635 |
Recruitment Status :
Active, not recruiting
First Posted : August 31, 2021
Last Update Posted : February 8, 2023
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Sponsor:
Hutchison Medipharma Limited
Information provided by (Responsible Party):
Hutchmed ( Hutchison Medipharma Limited )
Tracking Information | |||||
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First Submitted Date ICMJE | August 8, 2021 | ||||
First Posted Date ICMJE | August 31, 2021 | ||||
Last Update Posted Date | February 8, 2023 | ||||
Actual Study Start Date ICMJE | October 27, 2021 | ||||
Estimated Primary Completion Date | December 30, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
the durable response rate in the primary study [ Time Frame: treatment period Week14-Week24 ] Platelet count ≥50×10^9 /L on at least 4 of 6 scheduled visits of Week14-Week24 in the primary study
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase III Study on HMPL-523 for Treatment of ITP | ||||
Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-523 in Treatment of Primary Immune Thrombocytopenia (ITP) in Adults(ESLIM-01 Study) | ||||
Brief Summary | 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). | ||||
Detailed Description | This is a randomized, double-blind, placebo-controlled phase III clinical trial in adult patients with primary immune thrombocytopenia to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP) | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Primary Immune Thrombocytopenia (ITP) | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
188 | ||||
Original Estimated Enrollment ICMJE |
177 | ||||
Estimated Study Completion Date ICMJE | December 30, 2023 | ||||
Estimated Primary Completion Date | December 30, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05029635 | ||||
Other Study ID Numbers ICMJE | 2020-523-00CH1 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Hutchmed ( Hutchison Medipharma Limited ) | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Hutchison Medipharma Limited | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Hutchmed | ||||
Verification Date | February 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |