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Immune Thrombocytopenia (ITP)Phase 1NCT03951623

The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients

A Phase 1 study testing HMPL-523 in people with Immune Thrombocytopenia (ITP), run by Hutchison Medipharma Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Immune Thrombocytopenia (ITP)
What is being tested?
HMPL-523
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteChina
Study dates
12 Aug 2019to 31 Jul 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Blood diseases hospital, Chinese academy of medical university

    Tianjin, Tianjin Municipality, 300000

Other trials in China

About this study

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

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.

Read the 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) .

Being tested
HMPL-523, Placebo
Keywords
syk inhibitor, ITP
Medical subject headings
Purpura, Thrombocytopenic, Idiopathic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HMPL-523Drug

    HMPL-523 will be oral administrated once daily for 8 weeks and 16 weeks open-label treatment.

  • PlaceboDrug

    HMPL-523 matching placebo will be oral administrated once daily for 8 weeks and 16 weeks open-label treatment.

Study groups in NCT03951623
Study groupRoleWhat they receive
treatment armActive comparatorEligible 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.
Receives: Drug: HMPL-523
placebo armPlacebo comparatorEligible subjects will be treated with HMPL-523 matching placebo once daily for 8 weeks and 16 weeks open-label treatment.
Receives: Drug: HMPL-523; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with any Adverse Event

    Adverse Events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Measured: From first dose to within 28 days after the last dose

Secondary outcomes (3)

  1. Maximum plasma concentration (Cmax)

    Maximum plasma concentration (Cmax)

    Measured: Day 15, 16, 29, 43 and 47

  2. Area under the concentration-time curve in a selected time interval (AUC0-t)

    Area under the concentration-time curve in a selected time interval (AUC0-t)

    Measured: Day 15, 16, 29, 43 and 47

  3. Rate of Clinical Remission

    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)

    Measured: Day 1 to 8 weeks treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2019
  2. Study start12 Aug 2019
  3. Primary completion30 Oct 2021
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03951623
Sponsor's protocol ID
2018-523-00CH1
Status last verified
Jul 2024
First submitted
14 May 2019
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu X, Zhou H, Hu Y, Yin J, Li J, Chen W, Huang R, Gong Y, Luo C, Mei H, Ding B, Gu C, Sun H, Leng Y, Ji D, Li Y, Yin H, Shi H, Chen K, Wang J, Fan S, Su W, Yang R. Sovleplenib (HMPL-523), a novel Syk inhibitor, for patients with primary immune thrombocytopenia in China: a randomised, double-blind, placebo-controlled, phase 1b/2 study. Lancet Haematol. 2023 Jun;10(6):e406-e418. doi: 10.1016/S2352-3026(23)00034-0. Epub 2023 Apr 4.

    PubMed 37028433

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HMPL-523 in people with Immune Thrombocytopenia (ITP), run by Hutchison Medipharma Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with any Adverse Event (time frame: From first dose to within 28 days after the last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03951623, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.

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