Clinical trial NCT05583838: A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts
Official title: Comparing the Efficacy and Safety of Optimized rhTPO Treatment Versus Eltrombopag Treatment in Previously Treated Primary Immune Thrombocytopenia Patients: A Multicenter Randomized Open-label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Previously Treated Primary Immune Thrombocytopenia
Keywords: rhTPO
Eltrombopag
Pre-treated
Primary Immune Thrombocytopenia
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Hebei Medical University
name: Xijing Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: The Second Affiliated Hospital of Kunming Medical University
name: Second Affiliated Hospital of Guangzhou Medical University
name: Shaanxi Provincial People's Hospital
name: Henan Cancer Hospital
name: North China University of Science and Technology Affiliated Hospital
name: The Second Affiliated Hospital of Dalian Medical University
name: Second Hospital of Shanxi Medical University
name: The Second Affiliated Hospital of Harbin Medical University
name: Shenyang Sunshine Pharmaceutical Co., LTD.
name: First Affiliated Hospital of Xinjiang Medical University
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: Kashgar 1st People's Hospital
name: Xi'an Central Hospital
name: Beijing Public Health Foundation
name: Yuyao People's Hospital
First posted: 2022-10-18
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.

Detailed description: A multicenter randomized open-label trial to compare the efficacy and safety of an optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia. Total treatment duration is 6 weeks, the primary endpoint is "median time to achieve platelet count ≥50x10\^9/L during 6 weeks observation".

Eligibility criteria: Inclusion Criteria:

* Subject is ≥18 years old.
* Disease duration is ≥3 months, diagnosed and treated as ITP prior to screening.
* Baseline platelet count \<30×10\^9/L.
* Subjects treated with maintenance corticosteroids or immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
* Informed consent has been signed.

Exclusion Criteria:

* Classified as refractory ITP.
* Subjects with any prior history of arterial or venous thrombosis, or thrombophilia in recent 1 year.
* Subjects who have previously received any platelet increasing drug such as rhTPO, thrombopoietin receptor agonist(TPO-RA), etc. within 30 days.
* Subjects who are known nonresponders to rhTPO or TPO-RA therapy.
* Subjects with positive hepatitis C virus antibody or human immunodeficiency virus(HIV) antibody, positive HBsAg and serum levels of hepatitis B virus (HBV) DNA \>1000cps/ml.
* TBil or Scr\> 1.5 x upper limit of normal (ULN), ALT or AST\> 3.0 x ULN in recently 2 weeks.
* Subjects with any prior history of tumor.
* Female subjects who are nursing or pregnant.
* Any situation that investigate consider not suitable for pts to join the study.

Primary outcomes:
measure: Median time to achieve platelet count ≥50x10^9/L during 6 weeks observation
timeFrame: in 6 weeks treatment
Secondary outcomes:
measure: Early response
timeFrame: after 1 week treatment
measure: Initial response
timeFrame: after 1 month treatment
measure: 6 weeks response
timeFrame: after 6 weeks treatment
measure: 4 months response
timeFrame: after 4 months treatment
measure: Durable response
timeFrame: after 6 months treatment
measure: Time to treatment failure
timeFrame: in 6 weeks treatment
measure: Incidence of adverse events
timeFrame: from study start date to the end of follow-up, up to 6 months
measure: Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0
timeFrame: from study start date to the end of follow-up, up to 6 months
measure: Number of subjects who develop anti-rhTPO antibodies
timeFrame: from study start date to the end of follow-up, up to 6 months
measure: The duration time with platelet count ≥50x10^9/L
timeFrame: in 6 weeks treatment
Other outcomes:
Locations:
city: Nanning
country: China
facility: The Second Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: the Second Hospital of HeBei Medical University
state: Hebei
city: Tangshan
country: China
facility: North China University of Science and Technology Affiliated Hospital
state: Heibei
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
state: Henan
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of the Fourth Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Tianjin
country: China
facility: Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
state: Tianjin
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Kashgar
country: China
facility: Kashgar District 1st People's Hospital
state: Xinjiang
city: Ürümqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Ürümqi
country: China
facility: The first affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Yuyao
country: China
facility: Yuyao People's Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
name: Lei Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: