Clinical trial NCT04214951: A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia
Official title: A Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corticosteroid-resistant or Relapsed ITP
Keywords: Immune Thrombocytopenia
Recombinant human thrombopoietin
Eltrombopag
switching
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult ITP patients

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.

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.

Eligibility 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 -

Primary outcomes:
measure: Response Rate at 6 Weeks After Switching
timeFrame: 6 weeks
Secondary outcomes:
measure: Treatments Associated Adverse Events
timeFrame: 6 weeks
measure: Reasons of Switching
timeFrame: 6 weeks
measure: Number of Participants With Bleeding Events
timeFrame: 6 weeks
measure: TOR (Time to Response)
timeFrame: 6 weeks
measure: DOR (Duration of Response)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xiao Hui Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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