NCT02403440

Brief Summary

The purpose of this study is to obtain information on efficacy, safety and Pharmacokinetics (PK)/Pharmacodynamics (PD) of Hetrombopag over 14 days in Chinese patients with chronic ITP.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 20, 2015

Last Update Submit

March 30, 2015

Conditions

Purpura, Thrombocytopenic, Idiopathic

Outcome Measures

Primary Outcomes (1)

  • The number of volunteers with adverse events as a measure of safety and tolerability

    up to Day 28

Secondary Outcomes (2)

  • Plasma pharmacokinetic (PK) parameters of Hetrombopag after multiple dose from day 1 to day 14, composite including AUC, Cmax, Tmax, and t1/2

    day 1 and day 14

  • The proportion of patients with platelet counts ≥50,000/µL after treatment

    up to Day 28

Study Arms (1)

Hetrombopag Olamine

EXPERIMENTAL

Hetrombopag Olamine 2.5mg, 5mg and 7.5mg

Drug: Hetrombopag Olamine

Interventions

Hetrombopag OlamineDRUG

Hetrombopag Olamine 2.5mg, 5mg and 7.5mg

Hetrombopag Olamine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronical ITP patients.
  • The subjects were diagnosed as ITP with bone marrow aspiration within 3 months before enrollment or in the screening period. And secondary immune thrombocytopenia (e.g., myelodysplastic syndrome, systemic lupus erythematosus, aplastic anemia) was excluded.
  • Patients had a mean platelet count of less than 30,000/µL in the screening period.
  • Patients receiving chronic maintenance steroid therapy must have received a stable dose for at least 1 month.
  • Patients receiving danazol, mycophenolate mofetil or cyclosporine A must have received a stable dose for at least 12 weeks.
  • Normal PT/INR and APTT.

You may not qualify if:

  • Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any other family history of arterial or venous thrombosis.
  • Pre-existing cardiovascular disease (congestive heart failure, New York Heart Association \[NYHA\] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation).
  • Malignant disease
  • Cancer treatment with cytotoxic chemotherapy and/or radiotherapy.
  • Patients with one of the following conditions should be excluded:
  • Treatment with immunoglobulins within 1 week preceding the first dose of study medication.
  • Treatment with splenectomy or rituximab within 12 weeks preceding the first dose of study medication.
  • Treatment with eltrombopag or Nplate within 4 weeks preceding the first dose of study medication.
  • Treatment with cyclophosphamide or vinca alkaloids within 4 weeks preceding the first dose of study medication.
  • ALT\>2×ULN，AST\>2×ULN，Total Bilirubin\>1.5×ULN，serum creatinine \>1.2×ULN，Total albumin \<0.9×LLN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Hospital, Sichuan University

Chengdu, China

RECRUITING

Related Publications (1)

  • Wang Z, Chen L, Zhang F, Lu H, Chen X, Wen A, Luo J, Hu Y, Wang Y, Niu T, Zheng L. First-in-patient study of hetrombopag in patients with chronic idiopathic thrombocytopenic purpura. J Thromb Haemost. 2020 Nov;18(11):3053-3060. doi: 10.1111/jth.15078. Epub 2020 Oct 1.

    PMID: 32865293DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2015

First Posted

March 31, 2015

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

CN(1)