drugset / Trial / NCT04410965

Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks

NCT04410965

Phase 4 Completed 82 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: Evaluate the relationship between ABCG2 mutation (rs2231142) and teriflunomide exposure, during 6-month treatment with teriflunomide 14 mg Secondary Objective: Characterize the safety (AEs, such as ALT enhancement, hair thinning, diarrhea, nausea, etc.) during 6-month treatment with teriflunomide

Timeline

Start
2020-05-20
Primary completion
2021-07-12
Completion
2021-07-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Teriflunomide Small molecule 14 mg Oral

Indications