A Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 13 April 2015
• Main ID: NCT02403440
• Date of registration: 20/03/2015
• Prospective Registration: No
• Primary sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Public title: A Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients
• Scientific title: A Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura
• Date of first enrolment: April 2014
• Target sample size: 24
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02403440
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Liang Maozhi

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Chronical ITP patients.

2. 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.

3. Patients had a mean platelet count of less than 30,000/µL in the screening period.

4. Patients receiving chronic maintenance steroid therapy must have received a stable
dose for at least 1 month.

5. Patients receiving danazol, mycophenolate mofetil or cyclosporine A must have
received a stable dose for at least 12 weeks.

6. Normal PT/INR and APTT.

Exclusion Criteria:

1. 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.

2. 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).

3. Malignant disease

4. Cancer treatment with cytotoxic chemotherapy and/or radiotherapy.

5. 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.

6. ALT>2×ULN,AST>2×ULN,Total Bilirubin>1.5×ULN,serum creatinine >1.2×ULN,Total albumin
<0.9×LLN



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Purpura, Thrombocytopenic, Idiopathic

Intervention(s)

Drug: Hetrombopag Olamine

Primary Outcome(s)

The number of volunteers with adverse events as a measure of safety and tolerability [Time Frame: up to Day 28]

Secondary Outcome(s)

The proportion of patients with platelet counts =50,000/µL after treatment [Time Frame: up to Day 28]

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

Secondary ID(s)

TPOPId

Source(s) of Monetary Support

Please refer to primary and secondary sponsors