Safety and Efficacy Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT02614846
• Date of registration: 19/11/2015
• Prospective Registration: No
• Primary sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Public title: Safety and Efficacy 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: August 2015
• Target sample size: 29
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02614846
• 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: Yu Hu, Ph.D

• Name: Yu Hu, Ph.D

Key inclusion & exclusion criteria

Inclusion Criteria:

- Inclusion Criteria:

1. Confirmed diagnosis of chronic ITP,a peripheral blood smear or bone marrow
examination should support the diagnosis of ITP with no evidence of other causes
of thrombocytopenia.

2. Patients had a platelet count of less than 30,000/µL both in the screening
period and baseline.

3. Subjects who are refractory or have relapsed after at least one prior ITP
therapy.

4. Previous therapy for ITP including rescue must have been completed at least 2
weeks prior to randomization.

5. Subjects treated with maintenance immunosuppressive therapy must be receiving a
dose that has been stable for at least 1 month.

6. A complete blood count (CBC), within the reference range, with the following
exceptions.

- Platelets <30×109/L is required for inclusion .

- Hemoglobin: females and males 10.0 g/dl are eligible for inclusion.

- Absolute neutrophil count (ANC) =1500/µL (1.5×109/L) is required for inclusion.

7.PT result no exceed normal by more than ±3s,APTT result no exceed normal by more
than ±10s.

8.Female subjects have a negative result with HCG testing in the screening period and
baseline.

- Exclusion Criteria:

1. Patients with any prior history of arterial or venous thrombosis,or diagnosis as
Thrombophilia.

2. Subjects diagnosed with tumor.

3. Have pre-existing cardiac disease within the last 3 months.No arrhythmia known
to increase the risk of thrombolic events (e.g. atrial fibrillation), or
patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients
with a Bundle Branch Block.

4. Female subjects who are nursing or pregnant at screening or pre-dose on
baseline.

5. Treatment with thrombopoietin or an investigational drug within 30 days or five
half-lives (whichever is longer) preceding the first dose of study medication.

6. Treatment with Rituximab or Splenectomy within the lat 6 months.

7. Subjects who have previously received eltrombopag or any other thrombopoietin
receptor agonist within 30 days or five half-lives (whichever is longer).

8. Subject has consumed aspirin, aspirin-containing compounds, salicylates,
anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3
consecutive days within 2 weeks of the study start and until the end of the
study.

9. Any laboratory or clinical evidence for HIV infection.Any clinical history for
hepatitis C infection; chronic hepatitis B infection; or any evidence for active
hepatitis at the time of subject screening.



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

Health Condition(s) or Problem(s) studied

Chronic Idiopathic Thrombocytopenic Purpura

Intervention(s)

Drug: Hetrombopag Olamine

Primary Outcome(s)

The number of subjects with adverse events as a measure of safety and tolerability. [Time Frame: From Day 1 to Day 70.]

Secondary ID(s)

HR-TPO- Ie-ITP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors