- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03951623
The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients
October 20, 2020 updated by: Hutchison Medipharma Limited
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
This is a randomized, double blinded, placebo-controlled phase Ib clinical trial in adult patients with immune thrombocytopenia.
Cross-over treatment will be allowed during the study.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Approximate 51 to 60 patients will be enrolled in dose escalation (3 cohorts, 8-20 subjects each with the ratio of 3:1 vs Placebo) .
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: jiayi Mai
- Phone Number: 086-021-20673063
- Email: Jiayim@hmplglobal.com
Study Locations
-
-
Tianjin
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Tianjin, Tianjin, China, 300000
- Recruiting
- Blood diseases hospital, Chinese academy of medical university
-
Contact:
- Renchi Yang
- Email: rcyang65@163.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent form
- 18~75 years old male of female
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Diagnosed immune thrombocytopenia before randomization with platelet decrease for more than 6 months.
- Patients with refractory or relapsed ITP who have been treated with 1st line anti-ITP regimen or have experienced splenectomy.
- Relative stable disease with World Health Organization (WHO) bleeding score of 0-1 and no rescue treatment needed within 2 weeks based on investigator's judgment.
Laboratory tests meet the following conditions:
- During screening stage, twice PLT<30x10^9/L(exceed 24 hours)
- Hb≥90g/L(if iron-deficiency anemia,Hb>80g/L),WBC>2.5x10^9/L, NEU>1.8x10^9/L
- Crea≤1.5xULN and CCR≥50mL/min
- TBIL、ALT、AST≤1.5xULN
- Amylase、lipase<ULN
- INR、APTT<20%xULN
Exclusion Criteria:
- Patients with secondary thrombocytopenia or patients have other auto immune diseases who need long term steroids or immunosuppressants treatment.
- Patients with Myelofibrosis, Myelodysplastic syndrome, Aplastic anemia, or other hematologic malignancies.
- Have splenectomy within 12 weeks before randomization
- Major surgery was performed within 4 weeks before randomization;Or require major elective surgery during the study period.
- Have malignant tumor(except basal cell carcinoma of skin and carcinoma in situ of cervix)
- Have previous/significant arterial/venous embolic disease
- History of serious cardiovascular disease, or QTc≥450 ms.
- Patients with resistant hypertension (Systolic blood pressure ≥140 mmHg or Diastolic blood pressure ≥90 mmHg)
- Has a history of severe gastrointestinal diseases, such as dysphagia, active gastric ulcer, and is unable to take oral medication or has absorption disorder
- HIV infection
- Uncontrolled, active infections
- Known history of clinically significant liver disease, such as hepatitis b(HBV DNA ≥2000IU/mL (or ≥1×104 copies)), hepatitis c, or cirrhosis
- Prior anti-ITP emergency treatment within 2 weeks before randomization.
- Prior anti-ITP treatment within 4 weeks before randomization except for stable dose steroids, including but not limited to Thrombopoietin, thrombopoietin receptor agonist, azathioprine, cyclosporine A and mycophenolate mofetil.
- Any condition requiring anti-coagulant therapy or the regular use of any medication having effluence to Platelet function.
- Exposure to Rituximab 14 weeks prior to randomization.
- Treament with Chinese medicine within 1 week before randomization.
- Use of strong cytochrome P450 isoform 3A inhibitors and inducers and drugs metabolized by cytochrome P450 isoform 3A, cytochrome P450 isoform 2B6, and cytochrome P450 isoform 1A2, and are identified as narrow therapeutic drugs within 14 days or 5 half-lives, whichever is longer, prior to initiation of study treatment.
- Prior treatment with any spleen tyrosine kinase (SYK) inhibitors (eg, fostamatinib)
- Allergic to study drug active ingredient or excipient
- Subjects who have participated in clinical studies of drugs or invasive medical devices within 4 week before randomization
- Subjects have severe psychological or mental abnormalities
- Alcoholic or drug abuser
- Female subjects during pregnancy and lactation
- The investigator considered that the subjects were not suitable to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 and 16 weeks open-label treatment.
|
HMPL-523 will be oral administrated once daily for 8 weeks and 16 weeks open-label treatment.
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Placebo Comparator: placebo arm
Eligible subjects will be treated with HMPL-523 matching placebo once daily for 8 weeks and 16 weeks open-label treatment.
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HMPL-523 will be oral administrated once daily for 8 weeks and 16 weeks open-label treatment.
HMPL-523 matching placebo will be oral administrated once daily for 8 weeks and 16 weeks open-label treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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From first dose to within 28 days after the last dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plasma concentration (Cmax)
Time Frame: Day 15, 16, 29, 43 and 47
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Maximum plasma concentration (Cmax)
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Day 15, 16, 29, 43 and 47
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Area under the concentration-time curve in a selected time interval (AUC0-t)
Time Frame: Day 15, 16, 29, 43 and 47
|
Area under the concentration-time curve in a selected time interval (AUC0-t)
|
Day 15, 16, 29, 43 and 47
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Rate of Clinical Remission
Time Frame: Day 1 to 8 weeks treatment
|
Rate of Clinical Remission was defined as the proportion of patients with two consecutive visits in the first 8 weeks (including the 8th week) during the medication period, platelet count ≥30×10^9/L, and a 2-fold increase from baseline (no emergency treatment during the period)
|
Day 1 to 8 weeks treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hongyan Yin, Hutchison MediPharma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 12, 2019
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
May 14, 2019
First Submitted That Met QC Criteria
May 14, 2019
First Posted (Actual)
May 15, 2019
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 20, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura, Thrombocytopenic
- Purpura
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
Other Study ID Numbers
- 2018-523-00CH1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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