Treatment-naive Severe Aplastic AnemiaPhase 3NCT04961710
Extension Study of Hetrombopag in Severe Aplastic Anemia
A Phase 3 study testing Hetrombopag Olamine in people with Treatment-naive Severe Aplastic Anemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, placebo-control, phase 3 study of hetrombopag in patients with treatment-naive severe aplastic anemia. All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Treatment-naive Severe Aplastic Anemia
- What is being tested?
- Hetrombopag Olamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2019to 31 Dec 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who have completed or withdrawn from the HR-TPO-SAA-III study
- Subjects who have signed the informed consent form
- 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
- Subjects who have completed the end-of-treatment evaluation in the original study
Who cannot join
- Any unstable situation or situation that will compromise the safety of the subject
- Evidence of clonal cytogenetic abnormalities at the end-of-treatment examination of the HR-TPO-SAA-III study
- Subjects with uncontrollable hemorrhage and/or infection after standard treatment
- Subjects who have experienced deep vein thrombosis, myocardial infarction, stroke, or peripheral arterial embolism within 1 year
- Any situation that may compromise the subject and the safety or compliance thereof during the study
Trial locations and contacts
1 site in 1 country.
China1 site
Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
About this study
Official title: Extension Study of Hetrombopag Olamine in Patients With Treatment-naive Severe Aplastic Anemia
This is a multicenter, placebo-control, phase 3 study of hetrombopag in patients with treatment-naive severe aplastic anemia. All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.
Subjects will receive the same study drug (hetrombopag or placebo) as in study HR-TPO-SAA-III, with the same doses and administration schedule or with modifications based on the actual conditions.
The primary objective of this extension study is to give the subjects participating in the HR-TPO-SAA-III study the continued access to the study drug (hetrombopag or placebo) after the completion of the HR-TPO-SAA-III study.
- Conditions
- Treatment-naive Severe Aplastic Anemia
- Being tested
- Hetrombopag Olamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag OlamineDrug
Hetrombopag Olamine; once daily
PlaceboDrug
Placebo; once daily
| Study group | Role | What they receive |
|---|---|---|
| Hetrombopag Olamine | Experimental | Not described Receives: Drug: Hetrombopag Olamine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of subjects with clonal evolution at 6 months and 18 months
Measured: 6 months and 18 months
All SIEs, regardless of whether they are related to the investigational product
Measured: 3 years
All SAEs, regardless of whether they are related to the investigational product
Measured: 3 years
All AEs resulting in discontinuation and withdrawal from study
Measured: 3 years
Secondary outcomes (8)
Red blood cell count
Measured: by 1day visit
Hemoglobin
Measured: by 1day visit
Platelet count
Measured: by 1day visit
White blood cell count
Measured: by 1day visit
Neutrophil count
Measured: by 1day visit
Reticulocyte count
Measured: by 1day visit
The 6-month and 18-month survival rates of subjects
Measured: 6 months and 18 months
The recurrence rates at 6 months and 18 months
Measured: 6 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start19 Sep 2019
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-naive Severe Aplastic AnemiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961710
- Sponsor's protocol ID
- HR-TPO-SAA-III-EXT
- Status last verified
- Sep 2024
- First submitted
- 12 Jul 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No