Clinical TrialID 8183

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

NCT05797623

Non-severe Aplastic Anemia

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Record Fields

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Clinical Trial Id
8183
Evidence Id
8183
Core Evidence Id
8183
Source Clinical Trial Id
8181
Herb2 Clinical Trial Id
HBCT008181
Nct Id
NCT05797623
Title
Safety and Effectiveness of Trappa Ethanolamine Tablets Combined With Ciclosporin in the Treatment of Primary Treatment of Non-severe Aplastic Anemia
Status
Recruiting
Phase
Phase 2
Study Result
No
Study Condition
Non-severe Aplastic Anemia
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Trappa ethanolamine tablets ; ciclosporin|DRUG: Placebo ; ciclosporin
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Treatment
Gender
All
Age
Child, Adult, Older_Adult
Enrollment
78
Outcome Measure
Full hematological response rate, About 13 weeks from the first medication to the evaluation.
Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.
Funded By
INDUSTRY
Location
Hematology Hospital of Chinese Academy of Medical Sciences, Tianjin, Tianjin, 30000, China
Other Id
SHR8735-201
Start Date
2023-04-26
Primary Completion Date
2024-05-30
Completion Date
2025-05-30
First Posted
2023-04-04
Results First Posted
Last Update Posted
2023-09-01
Study Document
Study Url
https://clinicaltrials.gov/study/NCT05797623
Title Cn
Title En
Safety and Effectiveness of Trappa Ethanolamine Tablets Combined With Ciclosporin in the Treatment of Primary Treatment of Non-severe Aplastic Anemia
Bilingual Status
semi_complete