Efficacy and Safety of Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Fail to Eltrombopag or Herombopag Treatment: a Single-center, Prospective, One-arm Clinical Trial

Who is this study for? Patients with adult immune thrombocytopenia with autoantibodies
What treatments are being studied? Avatrombopag
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This prospective, open-label, single-center, one-arm clinical trial aims at evaluating the efficacy and safety of avatrombopag in Chinese adult Immune Thrombocytopenia (ITP) patients with autoantibodies fail (due to intolerance or resistance) to eltrombopag or herombopag treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The patients have provided written informed consent prior to enrollment.

• Men and women greater than or equal to 18 years of age.

• Diagnosed as ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis), primary ITP with positive antinuclear antibody but not up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome.

• Platelet count\<30 ×10\^9/L at screening.

• Patients who have previously failed to receive Eltrombopag or Herombopag \[poor efficacy (Eltrombopag 75 mg/d or Herombopag 7.5 mg/D, at least 4 weeks), or the efficacy cannot be maintained\], or who have contraindications, can not tolerate or refuse Eltrombopag or Herombopag treatment.

• Treatment for ITP (including but not limited to glucocorticoids, recombinant human thrombopoietin, and other thrombopoietin receptor agonists other than Avatrombopag) must be completed before enrollment, or the dose must be stable or in a phase of reduction within 2 weeks before enrollment.

• Effective contraceptive measures will be taken during the clinical trial.

Locations
Other Locations
China
Institute of Hematology & Blood Diseases Hospital
RECRUITING
Tianjin
Contact Information
Primary
Rongfeng Fu, M.D.
furongfeng@ihcams.ac.cn
+862223909009
Backup
Lei Zhang, M.D.
zhanglei1@ihcams.ac.cn
+862223909240
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 52
Treatments
Experimental: Treatment group
Fifty-two subjects will be enrolled with the indicated treatment dose of avatrombopag
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov