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

Purpura, Thrombocytopenic, Idiopathic Clinical Trial

Official title:

A Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02403440
• Other study ID #: TPOPId
• Status: Recruiting
• Phase: Phase 1
• First received: March 20, 2015
• Last updated: March 30, 2015
• Start date: April 2014

Study information

• Verified date: March 2015
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• Hetrombopag Olamine
Hetrombopag Olamine 2.5mg, 5mg and 7.5mg

Locations

Country	Name	City	State
China	West Hospital, Sichuan University	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of volunteers with adverse events as a measure of safety and tolerability		up to Day 28	Yes
Secondary	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	No
Secondary	The proportion of patients with platelet counts =50,000/µL after treatment		up to Day 28	No