NCT02614846

Brief Summary

This study evaluates the safety and efficacy of 6 weeks dosing Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura Patients. All of the subjects in this study receive Hetrombopag.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
29

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

Enrollment Period

7 months

First QC Date

November 19, 2015

Last Update Submit

November 22, 2015

Conditions

Chronic Idiopathic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

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

    From Day 1 to Day 70.

Study Arms (1)

Hetrombopag Olamine

EXPERIMENTAL

All the subjects receive 6 weeks Hetrombopag Olamine dosing, 5mg for the first 2 weeks, 2.5mg or 7.5mg for the last 4 weeks according to the PLT counting.

Drug: Hetrombopag Olamine

Interventions

Hetrombopag OlamineDRUG
Hetrombopag Olamine

Eligibility Criteria

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

You may qualify if:

  • 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.
  • Patients had a platelet count of less than 30,000/µL both in the screening period and baseline.
  • Subjects who are refractory or have relapsed after at least one prior ITP therapy.
  • Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization.
  • Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
  • A complete blood count (CBC), within the reference range, with the following exceptions.
  • PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.
  • Female subjects have a negative result with HCG testing in the screening period and baseline.

You may not qualify if:

  • Patients with any prior history of arterial or venous thrombosis，or diagnosis as Thrombophilia.
  • Subjects diagnosed with tumor.
  • 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.
  • Female subjects who are nursing or pregnant at screening or pre-dose on baseline.
  • Treatment with thrombopoietin or an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
  • Treatment with Rituximab or Splenectomy within the lat 6 months.
  • Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days or five half-lives (whichever is longer).
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science and technology

Wuhan, Hubei, 430022, China

RECRUITING

Central Study Contacts

Yu Hu, Ph.D

CONTACT

dr_huyu@126.com

Heng Mei, Ph.D

CONTACT

mayheng@126.com

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

November 19, 2015

First Posted

November 25, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2016

Last Updated

November 25, 2015

Record last verified: 2015-11

Locations

CN(1)