TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.
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".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
157
initial therapy: rhTPO s.c, 300 or 600U/kg daily based on baseline platelet count; maintenance therapy: rhTPO s.c, 300 \~ 600U/kg every other day depends on platelet count.
initial therapy: Eltrombopag oral, 25 or 50mg daily based on baseline platelet count; maintenance therapy: Eltrombopag oral, 25 \~ 75mg daily or every other day depends on platelet count.
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
the Second Hospital of HeBei Medical University
Median time to achieve platelet count ≥50x10^9/L during 6 weeks observation
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.
Time frame: in 6 weeks treatment
Early response
Early response is defined as platelet count ≥ 30×10\^9/L and at least doubling baseline at 1 week.
Time frame: after 1 week treatment
Initial response
Initial response is defined as platelet count ≥ 30×10\^9/L and at least doubling baseline at 1 month.
Time frame: after 1 month treatment
6 weeks response
6 weeks response is defined as platelet count ≥ 30×10\^9/L and at least doubling baseline at 6 weeks.
Time frame: after 6 weeks treatment
4 months response
4 months response is defined as platelet count ≥ 30×10\^9/L and at least doubling baseline at 3 months.
Time frame: after 4 months treatment
Durable response
Durable response is defined as platelet count ≥ 30×10\^9/L and at least doubling baseline at 6 months.
Time frame: after 6 months treatment
Time to treatment failure
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 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
...and 7 more locations
Time frame: in 6 weeks treatment
Incidence of adverse events
treatment-related adverse events.
Time frame: 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 with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0
Time frame: from study start date to the end of follow-up, up to 6 months
Number of subjects who develop anti-rhTPO antibodies
Number of subjects who develop anti-rhTPO antibodies
Time frame: from study start date to the end of follow-up, up to 6 months
The duration time with platelet count ≥50x10^9/L
Total duration of time a subject had platelet count ≥50x10\^9/L during treatment
Time frame: in 6 weeks treatment