Who is sponsoring NCT03557099?

NCT03557099 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What drugs are being tested in NCT03557099?

Interventions in NCT03557099: Hetrombopag Olamine.

What condition does NCT03557099 study?

NCT03557099 studies Severe Aplastic Anemia.

Is NCT03557099 still recruiting?

NCT03557099 is currently completed. Last updated 29 July 2022.

Last reviewed 2022-07-29 · How we verify

NCT03557099

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

A Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Severe Aplastic Anemia （SAA） Patient

Completed Phase 1, PHASE2 Last updated 29 July 2022

What this trial tests

Phase 1, PHASE2 trial testing Hetrombopag Olamine in Severe Aplastic Anemia in 55 participants. Completed in 23 July 2020.

Timeline

20 June 2018

Primary endpoint
31 October 2019

23 July 2020

Quick facts

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	20 June 2018
Primary completion	31 October 2019
Estimated completion	23 July 2020
Sites	1 location across China

Drugs / interventions tested

Hetrombopag Olamine — full drug profile →

Conditions studied

Severe Aplastic Anemia — all drugs for Severe Aplastic Anemia →

Sponsor

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

Who can join

18 and older, any sex, with Severe Aplastic Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Multicentre, Open-label, single-arm, Phase II Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Severe Aplastic Anemia. 55 adult patients with SAA will be enrolled in the study. Treatment with Hetrombopag will be started at 7.5 mg/day and uptitrated according to the platelet count. The primary objective of the study is to assess the safety and efficacy of Hetrombopag in patients with SAA.

Publications & conference data

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

A multicenter phase II study on the efficacy and safety of hetrombopag in patients with severe aplastic anemia refractory to immunosuppressive therapy.
Peng G, He G, Chang H, Gao S, et al · · 2022 · cited 23× · PMID 35371427 · DOI 10.1177/20406207221085197
Iron chelation of hetrombopag in aplastic anemia: a post hoc analysis of a phase II study.
Yang W, Zhao X, He G, Chang H, et al · · 2022 · cited 5× · PMID 36220881 · DOI 10.1007/s00277-022-04968-8

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 Severe Aplastic Anemia

Currently open trials in the same condition.

NCT06622694 — CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed/Refractory Severe Aplastic Anemia · Phase 1 · recruiting
NCT06517641 — Clinical Trial of Upfront Haploidentical or Unrelated Donor BMT to Restore Normal Hematopoiesis in Aplastic Anemia · Phase 2 · recruiting
NCT06695741 — Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia · Phase 2 · recruiting
NCT06412497 — MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Se · Phase 2 · recruiting
NCT06378060 — Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia · Phase 2 · 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 NCT03557099 (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: 29 July 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/NCT03557099.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing