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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

NCT05797623 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-09-01

No results posted yet for this study

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.

Conditions

  • Non-severe Aplastic Anemia

Interventions

DRUG

Trappa ethanolamine tablets ; ciclosporin

Trappa ethanolamine tablets combined with ciclosporin

DRUG

Placebo ; ciclosporin

Placebo combined with ciclosporin

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2024-05-30
Completion
2025-05-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05797623 on ClinicalTrials.gov