Who is sponsoring NCT03222843?

NCT03222843 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What drugs are being tested in NCT03222843?

Interventions in NCT03222843: Hetrombopag Olamine, matching placebo.

What condition does NCT03222843 study?

NCT03222843 studies Idiopathic Thrombocytopenic Purpura.

Is NCT03222843 still recruiting?

NCT03222843 is currently completed. Last updated 3 August 2022.

Last reviewed 2022-08-03 · How we verify

NCT03222843

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 3 August 2022

What this trial tests

Phase 3 trial testing Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura in 424 participants. Completed in 7 January 2021.

Timeline

30 June 2017

Primary endpoint
11 November 2019

7 January 2021

Quick facts

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	424
Start date	30 June 2017
Primary completion	11 November 2019
Estimated completion	7 January 2021
Sites	3 locations across China

Drugs / interventions tested

Hetrombopag Olamine — full drug profile →
matching placebo — full drug profile →

Conditions studied

Idiopathic Thrombocytopenic Purpura — all drugs for Idiopathic Thrombocytopenic Purpura →

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Idiopathic Thrombocytopenic Purpura. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia.
Mei H, Liu X, Li Y, Zhou H, et al · · 2021 · cited 53× · PMID 33632264 · DOI 10.1186/s13045-021-01047-9
Dose tapering to withdrawal stage and long-term efficacy and safety of hetrombopag for the treatment of immune thrombocytopenia: Results from an open-label extension study.
Mei H, Liu X, Li Y, Zhou H, et al · · 2022 · cited 10× · PMID 34821020 · DOI 10.1111/jth.15602
Efficacy and safety and analysis of thrombopoietin receptor agonists for the treatment of immune thrombocytopenia in adults: analysis of a systematic review and network meta-analysis of randomized controlled trials and results of real-world safety data.
Liu Y, Zhang N, Jiang T, Li Y, et al · · 2025 · cited 4× · PMID 40196346 · DOI 10.3389/fmed.2025.1531824
Safety and efficacy of hetrombopag in patients with chronic immune thrombocytopenia: a single-arm, open-label, multi-center phase 1 study.
Mei H, Chen X, Zhou J, Luo J, et al · · 2022 · cited 4× · PMID 35282136 · DOI 10.21037/atm-21-4361
Switching from eltrombopag to hetrombopag in patients with primary immune thrombocytopenia: a post-hoc analysis of a multicenter, randomized phase III trial.
Mei H, Liu X, Li Y, Zhou H, et al · · 2024 · cited 2× · PMID 38842566 · DOI 10.1007/s00277-024-05826-5
Hetrombopag for patients with persistent primary immune thrombocytopenia: a post hoc analysis of a multicenter, randomized phase Ⅲ trial.
Mei H, Liu X, Li Y, Zhou H, et al · · 2025 · PMID 41368293 · DOI 10.1016/j.rpth.2025.103205
Bridging the gaps between randomized controlled trials and real-world use of thrombopoietin receptor agonists for adult primary immune thrombocytopenia: a systematic review and meta-analysis.
Luo L, Jin S, Song Z, Chong G, et al · · 2025 · PMID 41070063 · DOI 10.3389/fmed.2025.1667457

Verify or expand the search:

Other trials of Hetrombopag Olamine

Trials testing the same drug.

NCT06478537 — TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Terminat · Phase 2 · recruiting
NCT06433830 — Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy · Phase 2 · recruiting
NCT04961710 — Extension Study of Hetrombopag in Severe Aplastic Anemia · Phase 3 · active not recruiting
NCT03977805 — Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects · Phase 1 · completed
NCT03603132 — A Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics · Phase 1 · completed

Other recruiting trials for Idiopathic Thrombocytopenic Purpura

Currently open trials in the same condition.

NCT04014413 — Safety and Efficacy of Fecal Microbiota Transplantation · NA · recruiting

Other Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03222843 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
Last refreshed: 3 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03222843.

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