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

The Combination of Eltrombopag and Recombinant Human Thrombopoietin (rhTPO) Versus Eltrombopag Monotherapy as Subsequent Treatment for Immune Thrombocytopenia During the COVID-19 Pandemic

Sponsors

Lead Sponsor: Peking University People's Hospital

Source Peking University People's Hospital
Brief 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.

Detailed Description

During the COVID-19 pandemic, the classical subsequent treatment regimen for ITP of immunosuppressants and/or steroids might increase patients' susceptibility of virus infections. To minimize ITP patients' risk during the COVID-19 global crisis and to improve treatment efficacy, this treatment regimen of eltrombopag plus recombinant human thrombopoietin (rhTPO) should be investigated. Recombinant human thrombopoietin (rhTPO) is a full-length glycosylated-TPO produced by Chinese hamster ovary cells, which showed its effectiveness in ITP in a variety of studies. Eltrombopag, a small molecule agonist of thrombopoietin receptor (TPO-RA), was recommended as the subsequent treatment for ITP patients, which also already showed robust efficacy. Both eltrombopag and rhTPO demonstrated good safety in ITP patients. Since they increase the number of platelets through different mechanisms, and previous studies demonstrated that they might exert synergic effect. The investigators hypothesized that the combination of these two agents could be a promising option for ITP treatment. This study aimed to evaluate the sustained responses and safety of eltrombopag plus rhTPO as treatment for corticosteroid-resistant or relapsed ITP patients during the COVID-19 pandemic.

Overall Status Recruiting
Start Date August 31, 2020
Completion Date August 2022
Primary Completion Date August 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Complete response 6 months
Response 6 months
No response 6 months
Relapses 6 months
Secondary Outcome
Measure Time Frame
Early response 7 days
Initial response 1 month
Durable response 6 months
TOR (time to response) 6 months
DOR (duration of response) 6 months
Treatments associated adverse events 6 months
Reduction in bleeding symptoms 6 months
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Eltrombopag

Description: Eltrombopag 25-75 mg oral daily according to platelet response.

Other Name: Revolade

Intervention Type: Drug

Intervention Name: rhTPO

Description: Rh-TPO 300U/kg subcutaneous injection once daily for 7 consecutive days, followed by a tapering dose in maintenance therapy.

Arm Group Label: eltrombopag plus rhTPO

Other Name: TPIAO, tebiao

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Xiaohui Zhang, MD Principal Investigator Peking University People's Hospital, Peking University Insititute of Hematology
Overall Contact

Last Name: Xiaohui Zhang, MD

Phone: +86-13522338836

Email: [email protected]

Location
Facility: Status: Contact: Peking University Insititute of Hematology, Peking University People's Hospital Xiaohui Zhang [email protected]
Location Countries

China

Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Peking University People's Hospital

Investigator Full Name: Xiao Hui Zhang

Investigator Title: Vice president of Peking Univeristy Institute of Hematology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: eltrombopag plus rhTPO

Type: Experimental

Description: Combination of eltrombopag and rhTPO

Label: eltrombopag

Type: Active Comparator

Description: Eltrombopag monotherapy

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov