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NCT05433922: SAA
Efficacy and Safety of CSA and Avatrombopag for the Treatment of SAA in the Elderly
NA trial testing Avatrombopag in Severe Aplastic Anemia in 80 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Institute of Hematology & Blood Diseases Hospital, China |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 June 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Avatrombopag (AVATROMBOPAG) — full drug profile →
Conditions studied
- Severe Aplastic Anemia — all drugs for Severe Aplastic Anemia →
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Who can join
60 and older, any sex, with Severe Aplastic Anemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, single-arm clinical study. The objective was to evaluate the efficacy and safety of CSA in combination with Avatrombopag in elderly patients with very/sever aplastic anemia treated for the first time. The design was: cyclosporine 3 mg/kg orally in two divided doses, with cyclosporine trough concentrations maintained at 200-250 ng/ml for 3 months to achieve maximum efficacy, and Avatrombopag, which was administered in two dose groups, 40 mg orally once daily and 60 mg orally once daily, for a total of 24 weeks. Forty patients are expected to be enrolled in each dose group, and a total of 80 patients are expected to be enrolled if both dose groups are conducted. Evaluation endpoint: OR rate at 24 weeks of treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05433922
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Avatrombopag
Trials testing the same drug.
- NCT07051915 — The Holistic Study · Phase 3 · not yet recruiting
- NCT06254287 — Efficacy and Safety of Avatrombopag vs. Avatrombopag Combined With rhTPO in the Treatment of SAA · Phase 2 · unknown
- NCT05772546 — Avatrombopag vs. Placebo for CIT in GI Malignancies · Phase 2 · active not recruiting
- NCT05996393 — CsA+ATG+AVA vs. CsA+AVA for the Treatment of Newly-diagnosed SAA in the Elderly · Phase 4 · completed
- NCT06001567 — Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC · Phase 2 · unknown
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 Institute of Hematology & Blood Diseases Hospital, China trials
Trials by the same sponsor.
- NCT06991920 — Immune-targeted Combination With Chemotherapy for Acute Leukemia of Ambiguous Lineage · NA · not yet recruiting
- NCT07407010 — BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM · Phase 1 · not yet recruiting
- NCT07407140 — VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML · Phase 3 · not yet recruiting
- NCT07454226 — ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL · NA · not yet recruiting
- NCT07490288 — Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML · NA · not yet recruiting
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 NCT05433922 (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 Institute of Hematology & Blood Diseases Hospital, China
- Last refreshed: 27 June 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/NCT05433922.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing