Viewing Study NCT03557099



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Last Modification Date: 2024-10-26 @ 12:47 PM
Study NCT ID: NCT03557099
Status: COMPLETED
Last Update Posted: 2022-07-29
First Post: 2018-06-03

Brief Title: A Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Severe Aplastic Anemia SAA Patient
Sponsor: Jiangsu HengRui Medicine Co Ltd
Organization: Jiangsu HengRui Medicine Co Ltd

Study Overview

Official Title: A Multicentre Open-label Single-arm Phase II Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Severe Aplastic Anemia
Status: COMPLETED
Status Verified Date: 2020-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a Multicentre Open-label single-arm Phase II Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Severe Aplastic Anemia

55 adult patients with SAA will be enrolled in the study Treatment with Hetrombopag will be started at 75 mgday and uptitrated according to the platelet count The primary objective of the study is to assess the safety and efficacy of Hetrombopag in patients with SAA
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None