Brief Title
A Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Severe Aplastic Anemia （SAA） Patient
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
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 7.5 mg/day 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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Proportion of Subjects With Hematological Response
Condition
Severe Aplastic Anemia
Intervention
Hetrombopag Olamine
Study Arms / Comparison Groups
Hetrombopag Olamine
Description: Hetrombopag will be started at 7.5 mg/day and uptitrated according to the platelet count.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
55
Start Date
June 20, 2018
Completion Date
June 30, 2020
Primary Completion Date
October 31, 2019
Eligibility Criteria
Inclusion Criteria:
1. Previous diagnosis of refractory severe aplastic anemia, not meeting partial response
criteria after at least one treatment course of immunosuppressive therapy, not
suitable or unwilling to do hematopoietic stem cell transplantation.
2. Platelet count ≤ 30×109/L.
3. Signed informed consent.
Exclusion Criteria:
1. Bleeding and/or Infection not adequately responding to appropriate therapy.
2. Patients with a PNH clone size in neutrophils of ≥50%.
3. Treatment with immunosuppressive therapy within 6 months prior to study entry.
4. Any laboratory or clinical evidence for HIV infection. Any clinical history for
hepatitis C infection; chronic hepatitis B infection; or any evidence for active
hepatitis at the time of subjects screening.
5. ALT> 2.5 x upper limit of normal (ULN), AST> 2.5 x upper limit of normal (ULN) DBLI>
1.5 x upper limit of normal (ULN), Scr> upper limit of normal (ULN).
6. Subjects diagnosed with cirrhosis or portal hypertension.
7. Subjects diagnosed with tumor.
8. Patients with any prior history of congestive heart failure, arrhythmia, and
peripheral arteriovenous thrombosis within 1 year. With a history of myocardial
infarction or cerebral infarction within 3 months.
9. ECOG Performance Status of 3 or greater.
10. Female subjects who are nursing or pregnant within 6 months.
11. Subjects cannot take effective contraception.
12. Subjects have participated in other clinical trial within the 3 months prior to study
entry.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +86-021-50118402, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03557099
Organization ID
HR-TPO-SAA-II
Responsible Party
Sponsor
Study Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor
, ,
Verification Date
April 2020