Back to results

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

Primary Purpose

Immune Thrombocytopenia

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Eltrombopag

rhTPO

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring corticosteroid-resistant or relapsed ITP, eltrombopag, recombinant human thrombopoietin (rhTPO)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenic purpura (ITP)
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)
Subject is ≥ 18 years
Subject has signed and provided written informed consent.
Fertile patients must use effective contraception during treatment and observational period
Negative pregnancy test

Exclusion Criteria:

Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
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
Have a New York Heart Classification III or IV heart disease
Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
Have active hepatitis B or hepatitis C infection
Have a HIV infection
Have active infection requiring antibiotic therapy within 7 days prior to study entry
Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
Previous splenectomy
Had previous or concomitant malignant disease
Not willing to participate in the study.
Expected survival of < 2 years
Intolerant to murine antibodies
Immunosuppressive treatment within the last 2 weeks
Connective tissue disease
Autoimmune hemolytic anemia
Patients currently involved in another clinical trial with evaluation of drug treatment

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

eltrombopag plus rhTPO

eltrombopag

Arm Description

Combination of eltrombopag and rhTPO

Eltrombopag monotherapy

Outcomes

Primary Outcome Measures

Complete response

A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L.

Response

A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.

No response

No response (NR) was defined as platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.

Relapses

A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.

Secondary Outcome Measures

Early response

Early response was defined as the attainment of a platelet count ≥ 30 × 10⁹ and at least a doubling of baseline platelet count at 1 week.

Initial response

Initial treatment was defined as the attainment of a platelet count ≥ 30 × 10⁹ and at least a doubling of baseline platelet count at 1 month.

Durable response

Durable response was defined as the attainment of a platelet count ≥ 30 × 10⁹ and at least a doubling of baseline platelet count at 6 months.

TOR (time to response)

The time to achieve platelet count ≥ 30×10^9/L and at least 2-fold increase of the baseline count and absence of bleeding since start of treatment.

DOR (duration of response)

The duration of achieve platelet count ≥ 30×10^9/L and at least 2-fold increase of the baseline count and absence of bleeding since start of treatment.

Treatments associated adverse events

All patients were assessed for safety every week during the first 8 weeks of treatment, and at 2-week intervals thereafter. Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Reduction in bleeding symptoms

Changes of bleeding after treatment. Bleeding was defined in accordance with the WHO bleeding scale (0, no bleeding; 1, petechiae; 2, mild blood loss; 3, gross blood loss; and 4, debilitating blood loss).

Full Information

NCT ID

NCT04516837

First Posted

August 16, 2020

Last Updated

August 31, 2020

Sponsor

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04516837

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 31, 2020 (Actual)

Primary Completion Date

August 2021 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Thrombocytopenia

Keywords

corticosteroid-resistant or relapsed ITP, eltrombopag, recombinant human thrombopoietin (rhTPO)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

eltrombopag plus rhTPO

Arm Type

Experimental

Arm Description

Combination of eltrombopag and rhTPO

Arm Title

eltrombopag

Arm Type

Active Comparator

Arm Description

Eltrombopag monotherapy

Intervention Type

Drug

Intervention Name(s)

Eltrombopag

Other Intervention Name(s)

Revolade

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

rhTPO

Other Intervention Name(s)

TPIAO, tebiao

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete response

Description

A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L.

Time Frame

6 months

Title

Response

Description

A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.

Time Frame

6 months

Title

No response

Description

Time Frame

6 months

Title

Relapses

Description

A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Early response

Description

Early response was defined as the attainment of a platelet count ≥ 30 × 10⁹ and at least a doubling of baseline platelet count at 1 week.

Time Frame

7 days

Title

Initial response

Description

Initial treatment was defined as the attainment of a platelet count ≥ 30 × 10⁹ and at least a doubling of baseline platelet count at 1 month.

Time Frame

1 month

Title

Durable response

Description

Durable response was defined as the attainment of a platelet count ≥ 30 × 10⁹ and at least a doubling of baseline platelet count at 6 months.

Time Frame

6 months

Title

TOR (time to response)

Description

The time to achieve platelet count ≥ 30×10^9/L and at least 2-fold increase of the baseline count and absence of bleeding since start of treatment.

Time Frame

6 months

Title

DOR (duration of response)

Description

The duration of achieve platelet count ≥ 30×10^9/L and at least 2-fold increase of the baseline count and absence of bleeding since start of treatment.

Time Frame

6 months

Title

Treatments associated adverse events

Description

Time Frame

6 months

Title

Reduction in bleeding symptoms

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenic purpura (ITP) 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) Subject is ≥ 18 years Subject has signed and provided written informed consent. Fertile patients must use effective contraception during treatment and observational period Negative pregnancy test Exclusion Criteria: Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL 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 Have a New York Heart Classification III or IV heart disease Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures Have active hepatitis B or hepatitis C infection Have a HIV infection Have active infection requiring antibiotic therapy within 7 days prior to study entry Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug Previous splenectomy Had previous or concomitant malignant disease Not willing to participate in the study. Expected survival of < 2 years Intolerant to murine antibodies Immunosuppressive treatment within the last 2 weeks Connective tissue disease Autoimmune hemolytic anemia Patients currently involved in another clinical trial with evaluation of drug treatment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaohui Zhang, MD

Phone

+86-13522338836

zhangxh100@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xuelin Dou, MD

Phone

+86-15510491556

dxldw@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaohui Zhang, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100010

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaohui Zhang

zhangxh100@sina.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs