Previously Treated Primary Immune Thrombocytopenia
Conditions
Keywords
rhTPO, Eltrombopag, Pre-treated, Primary Immune Thrombocytopenia
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.
Interventions
DRUGrhTPO
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.
DRUGEltrombopag
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.
Sponsors
The Second Hospital of Hebei Medical University
Xijing Hospital
The Affiliated Hospital of Inner Mongolia Medical University
The Second Affiliated Hospital of Kunming Medical University
Second Affiliated Hospital of Guangzhou Medical University
Shaanxi Provincial People's Hospital
Henan Cancer Hospital
North China University of Science and Technology
The Second Affiliated Hospital of Dalian Medical University
Second Hospital of Shanxi Medical University
The Second Affiliated Hospital of Harbin Medical University
Shenyang Sunshine Pharmaceutical Co., LTD.
First Affiliated Hospital of Xinjiang Medical University
People's Hospital of Xinjiang Uygur Autonomous Region
Kashgar 1st People's Hospital
Xi'an Central Hospital
Beijing Public Health Foundation
Yuyao People's Hospital
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Incidence of adverse events | from study start date to the end of follow-up, up to 6 months | treatment-related adverse events. |
| 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 |
| 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 |
| 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). |
Countries
China
Outcome results
None listed