|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
23 September 2024 |
|
Main ID: |
NCT04961710 |
|
Date of registration:
|
12/07/2021 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Extension Study of Hetrombopag in Severe Aplastic Anemia
|
|
Scientific title:
|
Extension Study of Hetrombopag Olamine in Patients With Treatment-naive Severe Aplastic Anemia |
|
Date of first enrolment:
|
September 19, 2019 |
|
Target sample size:
|
157 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT04961710 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Subjects who have completed or withdrawn from the HR-TPO-SAA-III study
2. Subjects who have signed the informed consent form
3. Female and male subjects of childbearing age who agree to take adequate
contraceptive measures during the extension study period and within 28 days after
the last dose
4. Subjects who have completed the end-of-treatment evaluation in the original study
Exclusion Criteria:
1. Any unstable situation or situation that will compromise the safety of the subject
2. Evidence of clonal cytogenetic abnormalities at the end-of-treatment examination of
the HR-TPO-SAA-III study
3. Subjects with uncontrollable hemorrhage and/or infection after standard treatment
4. Subjects who have experienced deep vein thrombosis, myocardial infarction, stroke,
or peripheral arterial embolism within 1 year
5. Any situation that may compromise the subject and the safety or compliance thereof
during the study
Age minimum:
15 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Treatment-naive Severe Aplastic Anemia
|
|
Intervention(s)
|
|
Drug: Hetrombopag Olamine
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
The ratio of subjects with clonal evolution at 6 months and 18 months
[Time Frame: 6 months and 18 months]
|
|
All AEs resulting in discontinuation and withdrawal from study
[Time Frame: 3 years]
|
|
All SAEs, regardless of whether they are related to the investigational product
[Time Frame: 3 years]
|
|
All SIEs, regardless of whether they are related to the investigational product
[Time Frame: 3 years]
|
|
Secondary Outcome(s)
|
|
Platelet count
[Time Frame: by 1day visit]
|
|
Hemoglobin
[Time Frame: by 1day visit]
|
|
Reticulocyte count
[Time Frame: by 1day visit]
|
|
The recurrence rates at 6 months and 18 months
[Time Frame: 6 months and 18 months]
|
|
Red blood cell count
[Time Frame: by 1day visit]
|
|
White blood cell count
[Time Frame: by 1day visit]
|
|
Neutrophil count
[Time Frame: by 1day visit]
|
|
The 6-month and 18-month survival rates of subjects
[Time Frame: 6 months and 18 months]
|
|
Secondary ID(s)
|
|
HR-TPO-SAA-III-EXT
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|