Trials / Completed
CompletedNCT04410965
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Study duration per participant is approximately 28 weeks including a 24-week treatment period
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TERIFLUNOMIDE | Pharmaceutical form:tablet Route of administration: oral |
Timeline
- Start date
- 2020-05-20
- Primary completion
- 2021-07-12
- Completion
- 2021-07-12
- First posted
- 2020-06-01
- Last updated
- 2025-09-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04410965. Inclusion in this directory is not an endorsement.