Fixed Low-dose Eltrombopag and rhTPO for Immune Thrombocytopenia (FLOWER)

NCT04518878 | Unknown Phase 1 DMC

• 1 other identifier: ITP-PKU019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm study to investigate the efficacy and safety of the combination of fixed low-dose eltrombopag plus recombinant human thrombopoietin (rhTPO) as treatment for corticosteroid-resistant or relapsed immune thrombocytopenia (ITP) patients during the COVID-19 pandemic.

Conditions

Immune Thrombocytopenia

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Complete response

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

  6 weeks

• Response

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

  6 weeks

• 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.

  6 weeks

• Relapses

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

  6 weeks

Secondary Outcomes (6)

• Early response

  7 days

• Initial response

  1 month

• TOR (time to response)

  6 weeks

• DOR (duration of response)

  6 weeks

• Treatments associated adverse events

  6 weeks

Study Arms (1)

Fixed Low-dose Eltrombopag and rhTPO

EXPERIMENTAL

Fixed Low-dose Eltrombopag and rhTPO

Drug: Eltrombopag; Drug: rhTPO

Interventions

Eltrombopag DRUG

Fixed dose of eltrombopag oral 25mg daily

Also known as: Revolade

Fixed Low-dose Eltrombopag and rhTPO

rhTPO DRUG

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

Also known as: TPIAO, tebiao

Fixed Low-dose Eltrombopag and rhTPO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100010, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Xiaohui Zhang, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhang, MD

CONTACT

+86-13522338836; zhangxh100@sina.com

Xuelin Dou, MD

CONTACT

+86-15510491556; dxldw@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Peking Univeristy Institute of Hematology

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 19, 2020
• Study Start: August 31, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)