Teriflunomide for Steroid-resistant/Relapse Immune Thrombocytopenia

NCT ID: NCT06190145

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-05
• Study Completion Date: 2025-06-15

Brief Summary

Single-arm, open-label, single-center study to evaluate the efficacy and safety of teriflunomide for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).

Detailed Description

This is a prospective, single-arm, open-label study of teriflunomide in approximately 40 patients with ITP who have relapsed or have an insufficient response to prior therapies. Teriflunomide is administered as 7 mg orally once daily with dose adjustments for 24 weeks. Efficacy and safety outcomes are assessed on scheduled study visits.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Teriflunomide

Oral Teriflunomide is given at a dose of 7 mg once daily with dose adjustments for 24 weeks. Treatment was discontinued if a dose-limiting toxic effect occurred, rescue medication was used, or concomitant medication for immune thrombocytopenia was changed beyond the 10% level as defined above.

Group Type: EXPERIMENTAL

Teriflunomide

Intervention Type: DRUG

Starting dose of 7 mg once daily. Dose adjustments were made throughout the study based on individual platelet counts.

Interventions

Teriflunomide

Starting dose of 7 mg once daily. Dose adjustments were made throughout the study based on individual platelet counts.

Intervention Type: DRUG

Other Intervention Names

AUBAGIO

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of primary immune thrombocytopenia (ITP) by excluding other supervened causes of thrombocytopenia

2. Patients with a platelet count <30,000/μL or a platelet count <50,000/μL with bleeding manifestations at the enrollment;

3. Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid tapering or after its discontinuation;

4. Willing and able to sign written informed consent.

Exclusion Criteria

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;

2. Secondary immune thrombocytopenia (e.g. patients with HIV, HCV, Helicobacter pylori infection, malignancy, or patients with confirmed autoimmune disease);

3. Pregnancy or lactation;

4. Pre-existing acute or chronic liver disease, or serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN);

5. Current or recent (< 4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection;

6. Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB;

7. Patients who are deemed unsuitable for the study by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Hui Zhang

Vice president of Peking Univeristy Institute of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiao-Hui Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University Institute of Hematology, Peking University People's Hospital

Locations

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao-Hui Zhang, MD

Role: CONTACT

zhangxh100@sina.com

+8613522338836

Li-Ping Yang, MD

Role: CONTACT

lpyangvip@163.com

+8618519172033

Facility Contacts

Xiao-Hui Zhang, MD

Role: primary

zhangxh100@sina.com

+8613522338836

Li-Ping Yang, MD

Role: backup

lpyangvip@163.com

+8618519172033

Other Identifiers

PKU-TFITP-02

Identifier Type: -

Identifier Source: org_study_id