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NCT05433922: SAA

Efficacy and Safety of CSA and Avatrombopag for the Treatment of SAA in the Elderly

Status unknown NA Last updated 27 June 2022
What this trial tests

NA trial testing Avatrombopag in Severe Aplastic Anemia in 80 participants. Status unknown.

Timeline
1 June 2022
Primary endpoint
31 December 2023
31 December 2024

Quick facts

Lead sponsorInstitute of Hematology & Blood Diseases Hospital, China
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment80
Start date1 June 2022
Primary completion31 December 2023
Estimated completion31 December 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

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.

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Other trials of Avatrombopag

Trials testing the same drug.

Other recruiting trials for Severe Aplastic Anemia

Currently open trials in the same condition.

Other Institute of Hematology & Blood Diseases Hospital, China trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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