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

NCT ID: NCT04516837

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2022-08-31

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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

eltrombopag plus rhTPO

Combination of eltrombopag and rhTPO

Group Type: EXPERIMENTAL

Eltrombopag

Intervention Type: DRUG

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

rhTPO

Intervention Type: DRUG

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

eltrombopag

Eltrombopag monotherapy

Group Type: ACTIVE_COMPARATOR

Eltrombopag

Intervention Type: DRUG

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

Interventions

Eltrombopag

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

Intervention Type: DRUG

rhTPO

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

Intervention Type: DRUG

Other Intervention Names

Revolade; 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

• 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

Xiaohui Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaohui Zhang, MD

Role: CONTACT

zhangxh100@sina.com

+86-13522338836

Xuelin Dou, MD

Role: CONTACT

dxldw@163.com

+86-15510491556

Facility Contacts

Xiaohui Zhang

Role: primary

zhangxh100@sina.com

Other Identifiers

ITP-PKU020

Identifier Type: -

Identifier Source: org_study_id