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NCT05018936
Efficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia
Phase 2, PHASE3 trial testing Hetrombopag in Aplastic Anemia in 40 participants. Status unknown.
1 October 2023
Quick facts
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 October 2021 |
| Primary completion | 1 October 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Hetrombopag — full drug profile →
Conditions studied
- Aplastic Anemia — all drugs for Aplastic Anemia →
- Drug Effect — all drugs for Drug Effect →
Sponsor
Peking Union Medical College Hospital
Who can join
Adults 18 to 75, any sex, with Aplastic Anemia or Drug Effect. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective one arm study to explore the efficacy and safety of Hetrombopag in non-severe aplastic anemia. Patients meeting the inclusion and exclusion criteria would be recruited. Treatment of Hetrombopag would be started with 5mg/day. The dosage would be increased by 2.5mg/day every 2 weeks if the platelet count remains less than 20×10e9/L and reduced if the platelet count reaches over than 150×10e9/L. The maximum dosage is 15mg/day. All patients would receive treatment for at least 6 months except that the platelet \<20×10e9/L at the dosage of 15mg/day for 4 weeks or the platelet ≥200×10e9/L at the dosage of 5mg/week for 2 weeks. The hematological response rate and safety will be recorded and compared at D15, 1month, 1.5month, 2month, 3month, 4month, 5month, 6month, 8month, 10month and 1year.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05018936
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Hetrombopag
Trials testing the same drug.
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- NCT07003269 — Observational Study: Hetrombopag for Platelet Recovery in Haploidentical HSCT · enrolling by invitation
- NCT06818916 — Hetrombopag in Promoting Platelet Engraftment After Auto-HSCT in Children With Neuroblastoma · NA · recruiting
- NCT06562738 — Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia · Phase 4 · recruiting
- NCT06099925 — The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With · Phase 2 · unknown
Other recruiting trials for Aplastic Anemia
Currently open trials in the same condition.
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- NCT06936930 — Reproductive and Mental Health of Patients With Aplastic Anemia · recruiting
- NCT06689800 — Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy · NA · recruiting
- NCT06613880 — Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia · Phase 2 · recruiting
Other Peking Union Medical College Hospital trials
Trials by the same sponsor.
- NCT07466251 — PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke · Phase 4 · not yet recruiting
- NCT06743321 — Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients · NA · not yet recruiting
- NCT07590336 — 68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma · Phase 1, PHASE2 · not yet recruiting
- NCT07515976 — Mapping of Genomic Structural Variations in Major Birth Defects · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05018936 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking Union Medical College Hospital
- Last refreshed: 24 August 2021
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/NCT05018936.
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