Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

424 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2021-01-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A multicentre, randomised, double-blind,4-stages phase III study enrolled 414 patients with chronic, previously treated ITP. Dosage could be adjusted (2.5\~.75 mg/day) to maintain platelet counts 50\~250×109/L

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02403440

Purpura, Thrombocytopenic, Idiopathic

UNKNOWN PHASE1

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

NCT02614846

Chronic Idiopathic Thrombocytopenic Purpura

UNKNOWN PHASE1

Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.

NCT01520909

Idiopathic Thrombocytopenic Purpura

COMPLETED PHASE3

RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag

NCT00370331

Purpura, Thrombocytopaenic, Idiopathic

COMPLETED PHASE3

Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)

NCT00540423

Chronic Idiopathic Thrombocytopenic Purpura Purpura, Thrombocytopenic, Idiopathic

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Thrombocytopenic Purpura

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

oral hetrombopag at an initial dose of 2.5 mg once daily

Group Type EXPERIMENTAL

Hetrombopag Olamine

Intervention Type DRUG

once daily

Arm 2

oral hetrombopag at an initial dose of 5 mg once daily

Group Type EXPERIMENTAL

Hetrombopag Olamine

Intervention Type DRUG

once daily

Arm 3

oral placebo at an initial dose of 2.5 mg once daily

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type DRUG

once daily

Arm 4

oral placebo at an initial dose of 5 mg once daily

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type DRUG

once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hetrombopag Olamine

once daily

Intervention Type DRUG

matching placebo

once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Confirmed diagnosis of ITP ≥6 months;Platelets \<30×109/L.
2. No evidence of other causes of thrombocytopenia.
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. PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.
7. Signed informed consent.

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. Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days .
6. 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.
7. 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.
8. ALT\> 1.5 x upper limit of normal (ULN), AST\> 3 x upper limit of normal (ULN)) DBLI\> 1.2 x upper limit of normal (ULN),Scr\> 1.2 x upper limit of normal (ULN)
9. The subject has participated in other clinical trial within the 3 months prior to randomization.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No