NCT Number: NCT04089267
Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
This is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP).
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
About this study
Evaluating the efficacy and safety of different human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP) This trial was designed as a multicenter, randomized, open, parallel controlled study
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age ≥ 18 years old, male or female
- For patients who have been diagnosed with ITP, the diagnostic criteria are consistent with the Chinese Expert Consensus on Diagnosis and Treatment of Primary Immune Thrombocytopenia (2016 Edition)
- Recurrence after previous treatment with glucocorticoids is ineffective or effective
- No contraindications to rhTPO (Terbyus) application, and willing to accept rhTPO treatment
- Platelet count before enrollment ≤ 30 × 109 / L, or > 30 × 109 / L but with active bleeding
- Volunteer to participate in the study and sign the informed consent form
Exclusion criteria
- pregnant or lactating
- Those with a history of thrombosis
- severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times
- Those who have used rhTPO in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following ITP treatments but have not yet reached the efficacy judgment time. : C-ball (7 days), vincristine or vinblastine amide or rhIL-11 (2 weeks), Eltrombopag (1 month), or rituximab (2 months)
- In the case of previous treatment of rhTPO: rhTPO 300U/kg/d, 14 days of treatment is invalid;
- Severe or uncontrollable infections
- have a history of mental illness
- The investigator believes that the patient is not eligible to participate in any other circumstances of the trial.
Treatment and study plan
Primary outcomes
-
The change in Platelet count from baseline on day 14 after the first dose
Time frame: for day 14
-
Total effective rate of ITP patients on day 14 (V6, D14 ± 1) after the first dose.
Time frame: for day 14
Secondary outcomes
-
The change in Platelet count from baseline on day 7 and day28 after the first dose
Time frame: for day7and day28
-
the total effective rate of treatment in ITP patients on day 7 and day 28
Time frame: for day7and day28
-
AE
Time frame: up to 28days
-
Incidence of anti-rhTPO antibodies
Time frame: up to 28days
-
Cav
Time frame: up to 28days
average Blood concentration at steady state Blood concentration at steady state Blood concentration at steady state
-
AUCss
Time frame: up to 28days
Sponsors and collaborators
Lead sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Industry
Registry information
Official study title
Multicenter, Randomized, Open, Parallel Controlled Trials Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2019
- First posted
- Sep 13, 2019
- Registry last updated
- Sep 13, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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