Eltrombopag Plus rhTPO Versus Eltrombopag for ITP During the COVID-19 Pandemic (ELABORATE-19)

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, multicenter, randomized, open-label study to investigate the efficacy and safety of eltrombopag plus recombinant human thrombopoietin (rhTPO) versus eltrombopag as treatment for corticosteroid-resistant or relapsed immune thrombocytopenia (ITP) during the COVID-19 pandemic.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital

Criteria

Inclusion Criteria:

1. Clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenic purpura (ITP)

2. Platelet count less than 30×10^9/L on two occasions or Platelets above 30×10^9/L combined with bleeding manifestation (WHO bleeding scale 2 or above)

3. Subject is ≥ 18 years

4. Subject has signed and provided written informed consent.

5. Fertile patients must use effective contraception during treatment and observational period

6. Negative pregnancy test

Exclusion Criteria:

1. Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL

2. Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper limit of normal

3. Have a New York Heart Classification III or IV heart disease

4. Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures

5. Have active hepatitis B or hepatitis C infection

6. Have a HIV infection

7. Have active infection requiring antibiotic therapy within 7 days prior to study entry

8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug

9. Previous splenectomy

10. Had previous or concomitant malignant disease

11. Not willing to participate in the study.

12. Expected survival of < 2 years

13. Intolerant to murine antibodies

14. Immunosuppressive treatment within the last 2 weeks

15. Connective tissue disease

16. Autoimmune hemolytic anemia

17. Patients currently involved in another clinical trial with evaluation of drug treatment