Efficacy and Safety of rhTPO and Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03771378
• Date of registration: 07/12/2018
• Prospective Registration: Yes
• Primary sponsor: Wuhan Union Hospital, China
• Public title: Efficacy and Safety of rhTPO and Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) (ITP;rhTPO)
• Scientific title: Efficacy and Safety of rhTPO and Eltrombopag in the Treatment of Chinese Adults With Primary Immune Thrombocytopenia (ITP):a Multicenter, Double-blind, Randomized, Controlled Trial
• Date of first enrolment: January 16, 2019
• Target sample size: 96
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03771378
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Hu Yu, M.D., Ph.D

• Name: Hu Yu, M.D., Ph.D
• Affiliation: Wuhan Union Hospital, China

• Name: zhou ming

Key inclusion & exclusion criteria

Inclusion Criteria:

1. The patient signs an informed consent form.

2. Age from 18 to 75 years old

3. The patient's first diagnosis of ITP is at least 6 months before enrollment; the
platelet count must <30×109/L before taking the study drug (48 hours before).

4. Patients who were diagnosed with ITP by bone marrow biopsy and other related
examinations before enrollment(Bone marrow biopsy is valid for 30 days, including 30
days);

5. The patient has been treated with splenectomy for relapse or relapse; or the patient
has not undergone splenectomy, but was ineffective or relapses after treatment with at
least one first line drug. Past ITP therapy can include, but is not limited to,
corticosteroids, immunoglobulins (IVIG or anti-D Immunoglobulin), azathioprine,
danazol, cyclophosphamide and immunomodulators;

6. Previous salvage treatments included infusion of platelets, immunoglobulins,
immunomodulators, and cyclophosphamide must be completed 2 weeks prior to enrollment
or treatment. Corticosteroids must end at least 14 days before enrollment.

7. Patients receiving immunosuppressive agents (including corticosteroids, azathioprine,
danazol, cyclosporin A, mycophenolate mofetil) or proprietary Chinese medicines have
maintained a stable therapeutic dose for at least the last month; patients who
received rituximab should be discontinued half a year prior to enrollment; patients
with spleen were enrolled six months after surgery;

8. No heart disease in the past 3 months, including NYHA grade III/IV charge

, heart failure, arrhythmia or myocardial infarction requiring medical treatment;

9. Laboratory tests for coagulation function showed that prothrombin time (PT/INR) and
activated partial thromboplastin time (APTT) values did not exceed 20% of the normal
reference range.No history of coagulation abnormalities except ITP;

10. White blood cell count, neutrophil absolute value, hemoglobin in the normal
value.Except in the following cases: a) Platelet count <30×10^9/L within Day1 or Day1
within 48 hours; b) Hemoglobin: if anemia is clearly caused by ITP (thrombocytopenia
caused blood loss), the lower limit of the subject's hemoglobin level below the normal
value can be based on the investigator's judgment to decide the subject whether to be
selected; c) absolute neutrophil count = 1.5 × 109 / L can be enrolled;

11. The following clinical biochemical indicators must be within 20% of the normal range:
creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin and
alkaline phosphatase. In addition, serum albumin is not lower than the lower limit of
normal value by 10%;

12. Subjects took an approved method of contraception. Female subjects (or female partners
of male subjects) must be infertile (hysterectomy, bilateral salpingectomy, bilateral
tubal ligation or more than 1 year after menopause) or have fertility but before the
first dose for 2 weeks, study-approved contraceptive methods were used throughout the
study period to 28 days after the end of the study or discontinuation of the
study.Male subjects with a fertile female partner must have undergone vasectomy or
consent to effective contraception throughout the study period (2 weeks prior to the
first dose, throughout the study period, until the end of the study or 28 days after
the discontinuation of the study) method;

13. Women with fertility must have a negative serum pregnancy test within 24 hours prior
to the first dose;

14. Subjects fully understand and are able to comply with the requirements of the research
protocol and are willing to complete the study as planned.

Exclusion Criteria:

1. Subjects had a history of any arterial/venous thrombosis (including stroke, transient
ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism)
and had at least 2 of the following risk factors: hormone replacement therapy, oral
contraception medicine (including estrogen), smoking, diabetes, hypercholesterolemia,
drug-controlled hypertension, malignant tumors, hereditary coagulopathy;

2. Abnormalities other than ITP during the screening phase or any medical history or
condition that the investigator considered unsuitable for participation in the study;

3. Patients with BMI = 28;

4. Pregnant or lactating women;

5. A history of alcohol/drug abuse within 12 months prior to screening or first dose;

6. Previous treatment with a specific study drug other than rhTPO or other research
treatments;

7. The subject has previously received or is currently receiving treatment with exenatide
or other thrombopoietin receptor agonists;

8. Throughout the study, medications that affected platelet function (including but not
limited to aspirin, clopidogrel and/or non-steroidal anti-inflammatory drugs NSAIDs)
or anticoagulant therapy were continued for >3 days;

9. Accept any herbal or nutritional supplements, excluding vitamin supplements and
mineral supplements within 1 week prior to the start of the study;

10. There is a history of abnormal platelet aggregation that may affect the reliability of
platelet count measurements;

11. Before the first dose administration, the bone marrow biopsy showed abnormality except
for ITP within 4 weeks, and the investigator judged that the abnormality made the
subject unsuitable for the study, or the bone marrow biopsy showed other primary
disease which caused thrombocytopenia;

12. Evidence of all laboratory or clinical HIV infections, previous clinical history of
hepatitis C,hepatitis B, or active hepatitis at screening. Laboratory tests during the
screening period indicate hepatitis C infection or hepatitis B infection. (Defined as
HBsAg test positive, in addition, if the HBsAg test is negative, but HBcAb is
positive, regardless of the status of HBsAb, HBV DNA testing is required, if positive,
subjects should be excluded);

13. Rescuing treatment is required before the first dose of the drug.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Immune Thrombocytopenia

Intervention(s)

Drug: eltrombopag

Drug: rhTPO

Primary Outcome(s)

Treatment response [Time Frame: 14 days from treatment]

Secondary Outcome(s)

Remission rate [Time Frame: 14 days from treatment]

Using ITP-specific bleeding assessment tool (ITP-BAT) to accessvbleeding scoer [Time Frame: 1 month from treatment]

Drug efficacy: Evaluation of effectiveness [Time Frame: 14 days from treatment]

The incidence of side effects of the drugs [Time Frame: 1 month from treatment]

Evaluation of effectiveness: the proportion of subjects, which the platelet count increased at least 2 times compared with baseline [Time Frame: 14 days from treatment]

The incidence of adverse events [Time Frame: 14 days from treatment]

Secondary ID(s)

T18008-A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The First Affiliated Hospital of Nanchang University

The Third Xiangya Hospital of Central South University

The First People's Hospital of Yuhang District

Xiangyang Central Hospital