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Safety and Effectiveness of Trappa Ethanolamine Tablets Combined With Ciclosporin in the Treatment of Primary Treatment of Non-severe Aplastic Anemia

Primary Purpose

Non-severe Aplastic Anemia

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Trappa ethanolamine tablets ; ciclosporin
Placebo ; ciclosporin
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-severe Aplastic Anemia

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 14-75 years old (including boundary value, whichever is at the time of signing the informed consent form), Gender is not limited. Diagnosed with non-heavy aplastic anemia within 6 months Life Functional Status (ECOG) Score 0-1 Those who understand the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent form in writing Exclusion Criteria: Total blood cell loss and myelohypoproliferative diseases caused by other reasons Chromosome karyotype analysis during screening shows clonal cytogenetic abnormalities Meet the severe aplastic anemia Paroxysmal sleep hemoglobinuria (PNH) clone ≥50% or hemolytic PNH clone Randomly receive ATG, ciclosporin, TPO-R agonists, androgens and other drugs to treat the relapse without completing the elution Pre-randomized treatment with erythropoietin Pre-randomized use of corticosteroids, G-CSF and GM-CSF treatment People with a history of hematopoietic stem cell transplantation subjects who had deep vein thrombosis, myocardial infarction, cerebral infarction or peripheral arterial embolism in the first 12 months Previous history of liver cirrhosis or portal hypertension When screening, alanine aminotransferase, barley transaminase, total bilirubin and blood creatinine are higher than the upper limit of normal value HIV infection or carrier in the past or screening; hepatitis C antibody positive; hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA test indicates virus replication Patients with randomized bleeding and/or infection that are still uncontrollable after standardized treatment Uncontrolled hypertension at screening, severe arrhythmia, level III/IV (graded by the New York Heart Association) congestive heart failure Those who are known or suspected to be contraindicated or highly sensitive to Trappa ethanolamine API or cyclosporine The subjects had any malignant solid tumors of the organ system in the first 5 years of screening, regardless of whether they had been treated, metastasis or relapsed, except for local skin basal cell carcinoma; subjects with blood tumors found in the past or screening Pregnant or lactating women Male subjects of women of childbearing age or partners of women of childbearing age refuse to use acceptable contraceptive measures from the period of taking the drug to 28 days after the last time of taking the drug. Randomly participated in other clinical trials and took research drugs in the first 3 months. The researchers believe that there is any situation that may cause the subject to be unable to complete the study or pose an obvious risk to the subject, or other factors that reduce the possibility of joining the group.

Sites / Locations

  • Hematology Hospital of Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trappa ethanolamine tablets combined with ciclosporin

Placebo combined with ciclosporin

Arm Description

Outcomes

Primary Outcome Measures

Full hematological response rate

Secondary Outcome Measures

Partial hematological response rate and total hematological response rate
Hematological response rate
The time required for the first hematological response
Changes in platelet count relative to the baseline of each visiting point of view
Changes in hemoglobin relative to the baseline of each visiting point of view
Changes in absolute neutrophil count relative to the baseline of each visiting point of view
Changes in reticulocyte count relative to the baseline of each visiting point of view
Cumulative proportion of patients who need blood transfusion
Cumulative total amount of platelet transfusions
Cumulative amount of red blood cell infusions
Cumulative proportion of patients with disease progression

Full Information

First Posted
March 22, 2023
Last Updated
August 31, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05797623
Brief Title
Safety and Effectiveness of Trappa Ethanolamine Tablets Combined With Ciclosporin in the Treatment of Primary Treatment of Non-severe Aplastic Anemia
Official Title
A Multicenter, Randomized, Double-blind, and Open-label, Placebo-controlled Phase II Clinical Study of Trappa Ethanolamine Tablets Combined With Ciclosporin in Patients With Treatment of Non-severe Aplastic Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a multicenter, randomized, double-blind, and open-label, placebo-controlled phase II clinical study. In order to evaluate the effectiveness and safety of trappa ethanolamine tablets combined with ciclosporin in the treatment of patients with non-severe aplastic anemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-severe Aplastic Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trappa ethanolamine tablets combined with ciclosporin
Arm Type
Experimental
Arm Title
Placebo combined with ciclosporin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Trappa ethanolamine tablets ; ciclosporin
Intervention Description
Trappa ethanolamine tablets combined with ciclosporin
Intervention Type
Drug
Intervention Name(s)
Placebo ; ciclosporin
Intervention Description
Placebo combined with ciclosporin
Primary Outcome Measure Information:
Title
Full hematological response rate
Time Frame
About 13 weeks from the first medication to the evaluation.
Secondary Outcome Measure Information:
Title
Partial hematological response rate and total hematological response rate
Time Frame
About 13 weeks from the first medication to the evaluation
Title
Hematological response rate
Time Frame
About 26 weeks from the first medication to the evaluation
Title
The time required for the first hematological response
Time Frame
About 26 weeks from the first medication to the evaluation
Title
Changes in platelet count relative to the baseline of each visiting point of view
Time Frame
About 26 weeks from the first medication to the evaluation
Title
Changes in hemoglobin relative to the baseline of each visiting point of view
Time Frame
About 26 weeks from the first medication to the evaluation
Title
Changes in absolute neutrophil count relative to the baseline of each visiting point of view
Time Frame
About 26 weeks from the first medication to the evaluation
Title
Changes in reticulocyte count relative to the baseline of each visiting point of view
Time Frame
About 26 weeks from the first medication to the evaluation
Title
Cumulative proportion of patients who need blood transfusion
Time Frame
About 26 weeks from the first medication to the evaluation
Title
Cumulative total amount of platelet transfusions
Time Frame
About 26 weeks from the first medication to the evaluation
Title
Cumulative amount of red blood cell infusions
Time Frame
About 26 weeks from the first medication to the evaluation
Title
Cumulative proportion of patients with disease progression
Time Frame
About 26 weeks from the first medication to the evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 14-75 years old (including boundary value, whichever is at the time of signing the informed consent form), Gender is not limited. Diagnosed with non-heavy aplastic anemia within 6 months Life Functional Status (ECOG) Score 0-1 Those who understand the research procedures and methods, voluntarily participate in this experiment, and sign the informed consent form in writing Exclusion Criteria: Total blood cell loss and myelohypoproliferative diseases caused by other reasons Chromosome karyotype analysis during screening shows clonal cytogenetic abnormalities Meet the severe aplastic anemia Paroxysmal sleep hemoglobinuria (PNH) clone ≥50% or hemolytic PNH clone Randomly receive ATG, ciclosporin, TPO-R agonists, androgens and other drugs to treat the relapse without completing the elution Pre-randomized treatment with erythropoietin Pre-randomized use of corticosteroids, G-CSF and GM-CSF treatment People with a history of hematopoietic stem cell transplantation subjects who had deep vein thrombosis, myocardial infarction, cerebral infarction or peripheral arterial embolism in the first 12 months Previous history of liver cirrhosis or portal hypertension When screening, alanine aminotransferase, barley transaminase, total bilirubin and blood creatinine are higher than the upper limit of normal value HIV infection or carrier in the past or screening; hepatitis C antibody positive; hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA test indicates virus replication Patients with randomized bleeding and/or infection that are still uncontrollable after standardized treatment Uncontrolled hypertension at screening, severe arrhythmia, level III/IV (graded by the New York Heart Association) congestive heart failure Those who are known or suspected to be contraindicated or highly sensitive to Trappa ethanolamine API or cyclosporine The subjects had any malignant solid tumors of the organ system in the first 5 years of screening, regardless of whether they had been treated, metastasis or relapsed, except for local skin basal cell carcinoma; subjects with blood tumors found in the past or screening Pregnant or lactating women Male subjects of women of childbearing age or partners of women of childbearing age refuse to use acceptable contraceptive measures from the period of taking the drug to 28 days after the last time of taking the drug. Randomly participated in other clinical trials and took research drugs in the first 3 months. The researchers believe that there is any situation that may cause the subject to be unable to complete the study or pose an obvious risk to the subject, or other factors that reduce the possibility of joining the group.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanyi Zhai
Phone
0518-82342973
Email
wanyi.zhai.wz5@hengrui.com
Facility Information:
Facility Name
Hematology Hospital of Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
30000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengkui Zhang

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Safety and Effectiveness of Trappa Ethanolamine Tablets Combined With Ciclosporin in the Treatment of Primary Treatment of Non-severe Aplastic Anemia

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