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NOT YET RECRUITING
NCT07278908
PHASE2/PHASE3

Avatrombopag Combined With All-trans Retinoic Acid in the Treatment of Primary Immune Thrombocytopenia

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

This study is an open label, randomized controlled, multicenter clinical trial aimed at comparing the efficacy and safety of the combination of atorvastatin and all trans retinoic acid with atorvastatin alone in the treatment of first-line ineffective or recurrent immune thrombocytopenia. The study is divided into a screening period (2 weeks), a treatment period (0-24 weeks), a reduction period (25-36 weeks), and a follow-up period (37-52 weeks), with a total of one year from the start of treatment to the end of follow-up (52 weeks).

Official title: Efficacy and Safety of Avatrombopag Versus Avatrombopag Combined With All-trans Retinoic Acid in the Treatment of Primary Immune Thrombocytopenia: a Multicenter, Open-label, Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2025-12

Completion Date

2028-12

Last Updated

2025-12-12

Healthy Volunteers

No

Interventions

DRUG

Avatrombopag+All trans retinoic acid

Avatrombopag, po, starting dose 20mg qd, later adjusted dose or frequency according to response; All trans retinoic acid, po, 10mg bid.

DRUG

Avatrombopag

Avatrombopag, po, starting dose 20mg qd, later adjusted dose or frequency according to response