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A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04214951
Recruitment Status : Active, not recruiting
First Posted : January 2, 2020
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital

Brief Summary:
Thrombopoietin Receptor Agonists (TPO-ra) are novel treatments for patients with refractory Primary Immune Thrombocytopenia (ITP). Rh-TPO and eltrombopag increase the number of platelets through different mechanism. If there is cross-resistance between 2 drugs for the treatment of adult ITP is still no answer. The purpose of this study is to investigate the efficacy and safety of switching eltrombopag and Rh-TPO in adults with ITP.

Condition or disease Intervention/treatment
Corticosteroid-resistant or Relapsed ITP Drug: Eltrombopag Drug: Recombinant human thrombopoietin (rh-TPO)

Detailed Description:
Non-interventional study. Patients who fail previous steroids and receive rh-TPO and then switch to EPAG or vice versa will be enrolled. The reason for switch will be recorded. Patients in the rh-TPO group were given rh-TPO 300 U/kg once daily for 21 days, and those in the eltrombopag group were given eltrombopag 50mg once daily for 6 weeks. Rh-TPO and eltrombopag were terminated any time the platelet counts increased above 100 × 10^9/L in the rh-TPO group and 300 × 10^9/L in the eltrombopag group. The efficacy, safety, and patient/physician preference will be assessed and compared between the two agents.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 2022


Group/Cohort Intervention/treatment
Recombinant human thrombopoietin (rh-TPO) group
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10^9/L. The efficacy, safety, and patient/physician preference will be assessed.
Drug: Recombinant human thrombopoietin (rh-TPO)
Patients will be given rh-TPO 300 U/kg once daily for 21 days.

Eltrombopag group
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10^9/L.The efficacy, safety, and patient/physician preference will be assessed.
Drug: Eltrombopag
Patients will be given eltrombopag 50mg once daily for 6 weeks.




Primary Outcome Measures :
  1. Response Rate at 6 Weeks After Switching [ Time Frame: 6 weeks ]
    The percentage of patients who have reached platelet count ≥ 50×10^9/L at 6 weeks after switching.


Secondary Outcome Measures :
  1. Treatments Associated Adverse Events [ Time Frame: 6 weeks ]
    Adverse event/serious adverse event associated with study drugs during 6 weeks after switching

  2. Reasons of Switching [ Time Frame: 6 weeks ]
    Reasons of switching eltrombopag and rh-TPO will be recorded, including lack of efficacy, patient preference, side effects, platelet count fluctuation

  3. Number of Participants With Bleeding Events [ Time Frame: 6 weeks ]
    Number of participants with bleeding events of the two groups during 6 weeks after switching

  4. TOR (Time to Response) [ Time Frame: 6 weeks ]
    The time to achieve platelet count ≥ 50×10^9/L after switching.

  5. DOR (Duration of Response) [ Time Frame: 6 weeks ]
    The duration of achieving platelet count ≥ 50×10^9/L after switching.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult ITP patients
Criteria

Inclusion Criteria:

1.18 years or older

2.Primary ITP

3.Platelet count ≤ 30 × 109/l

4.Normal neutrophils, reticulocyte count, creatinine and liver enzyme values

5.Available follow-up of 2 months at least for each period

6.Failed initial glucocorticosteroid treatment

7.Unwillingness to accept splenectomy or failed splenectomy

-

Exclusion Criteria:

  1. HIV, hepatitis B or C, Helicobacter pylori infection
  2. Malignancy
  3. Congenital or acquired immunologic deficit
  4. History of thrombosis plus two or more risk factors
  5. Nursing or pregnant women
  6. Abnormal liver and renal functions: AST/ALT/total bilirubin ≥1.5 × ULN, creatinine ≥1.5 mg/dl
  7. Severe heart and lung dysfunctions -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04214951


Locations
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China, Beijing
Peking University Institute of Hematology
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Xiao Hui Zhang, MD Peking University People's Hospital
  Study Documents (Full-Text)

Documents provided by Xiao Hui Zhang, Peking University People's Hospital:
Publications:

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Responsible Party: Xiao Hui Zhang, Clinical Professor, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04214951    
Other Study ID Numbers: ZXH-ITP2019
First Posted: January 2, 2020    Key Record Dates
Results First Posted: October 20, 2020
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiao Hui Zhang, Peking University People's Hospital:
Immune Thrombocytopenia
Recombinant human thrombopoietin
Eltrombopag
switching
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations