A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts
- Conditions
- Previously Treated Primary Immune Thrombocytopenia
- Interventions
- Registration Number
- NCT05583838
- 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".
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimized rhTPO treatment rhTPO The study in a 2:1 randomization ratio (117 subjects to rhTPO group). Eltrombopag treatment Eltrombopag The study in a 2:1 randomization ratio (58 subjects to Eltrombopag group).
- Primary Outcome Measures
Name Time Method Median time to achieve platelet count ≥50x10^9/L during 6 weeks observation in 6 weeks treatment Time from the start of treatment to the first time of achieving a platelet count ≥50x10\^9/L without salvage therapy during the first 6 weeks.
- Secondary Outcome Measures
Name Time Method 6 weeks response after 6 weeks treatment 6 weeks response is defined as platelet count ≥ 30×10\^9/L and at least doubling baseline at 6 weeks.
4 months response after 4 months treatment 4 months response is defined as platelet count ≥ 30×10\^9/L and at least doubling baseline at 3 months.
Incidence of adverse events from study start date to the end of follow-up, up to 6 months treatment-related adverse events.
Early response after 1 week treatment Early response is defined as platelet count ≥ 30×10\^9/L and at least doubling baseline at 1 week.
Initial response after 1 month treatment Initial response is defined as platelet count ≥ 30×10\^9/L and at least doubling baseline at 1 month.
Durable response after 6 months treatment Durable response is defined as platelet count ≥ 30×10\^9/L and at least doubling baseline at 6 months.
Time to treatment failure in 6 weeks treatment Treatment failure is defined as:
* a platelet count \< 30 x 10\^9/L for 4 consecutive weeks at the highest dose and schedule ; or,
* a major bleeding event; or,
* a change in therapy due to an intolerable side effect or bleeding symptoms (including a minor bleeding event).The duration time with platelet count ≥50x10^9/L in 6 weeks treatment Total duration of time a subject had platelet count ≥50x10\^9/L during treatment
Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0 from study start date to the end of follow-up, up to 6 months Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0
Number of subjects who develop anti-rhTPO antibodies from study start date to the end of follow-up, up to 6 months Number of subjects who develop anti-rhTPO antibodies
Trial Locations
- Locations (17)
The Second Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
the Second Hospital of HeBei Medical University
🇨🇳Shijiazhuang, Hebei, China
North China University of Science and Technology Affiliated Hospital
🇨🇳Tangshan, Heibei, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Xi'an Central Hospital
🇨🇳Xi'an, Shaanxi, China
Xijing Hospital of the Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
🇨🇳Xi'an, Shaanxi, China
Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
🇨🇳Tianjin, Tianjin, China
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
Kashgar District 1st People's Hospital
🇨🇳Kashgar, Xinjiang, China
The first affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
People's Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Ürümqi, Xinjiang, China
The Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Yuyao People's Hospital of Zhejiang Province
🇨🇳Yuyao, Zhejiang, China