Active, not recruitingNCT04961710Updated Sep 19, 2024

Extension Study of Hetrombopag in Severe Aplastic Anemia

A Phase 3 interventional study of Hetrombopag Olamine and Placebo in Treatment-naive Severe Aplastic Anemia, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as active, not recruiting.
Registered 1 year 9 months after the study started (first participant enrolled Sep 2019, registered Jul 2021).

Phase: Phase 3
Study type: Interventional
Enrollment: 157
Allocation: Non-randomized
Ages: 15 Years to 75 Years
Sex: All

Study 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 All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.

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 studied

Treatment-naive Severe Aplastic Anemia

Browse trials for

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 157 is above the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 15 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subjects who have completed or withdrawn from the HR-TPO-SAA-III study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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 157 participants (actual)

Study arms

Experimental
Hetrombopag Olamine
Drug: Hetrombopag Olamine
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugHetrombopag Olamine
Hetrombopag Olamine; once daily
DrugPlacebo
Placebo; once daily

What researchers measure

Primary outcomes

The ratio of subjects with clonal evolution at 6 months and 18 months
Time frame: 6 months and 18 months
All SIEs, regardless of whether they are related to the investigational product
Time frame: 3 years
All SAEs, regardless of whether they are related to the investigational product
Time frame: 3 years
All AEs resulting in discontinuation and withdrawal from study
Time frame: 3 years

Secondary outcomes

Red blood cell count
Time frame: by 1day visit
Hemoglobin
Time frame: by 1day visit
Platelet count
Time frame: by 1day visit
White blood cell count
Time frame: by 1day visit
Neutrophil count
Time frame: by 1day visit
Reticulocyte count
Time frame: by 1day visit
The 6-month and 18-month survival rates of subjects
Time frame: 6 months and 18 months
The recurrence rates at 6 months and 18 months
Time frame: 6 months and 18 months

Study locations

1 site

Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin 300020, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04961710
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Responsible party: Sponsor
First posted: Jul 14, 2021
Start date: Sep 19, 2019
Primary completion: Nov 30, 2024 (estimated)
Completion: Dec 31, 2024 (estimated)
Last update: Sep 19, 2024

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Anemia→

Other studies from this sponsor

Jiangsu HengRui Medicine Co., Ltd.

Start the discussion