Primary Immune Thrombocytopenic PurpuraPhase 2/3NCT04428255
A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP
A Phase 2/3 study testing HBM9161 Dose A and HBM9161 Dose B in people with Primary Immune Thrombocytopenic Purpura, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.
Trial summary
To select a dose and to make a decision for Phase 3 study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immune Thrombocytopenic Purpura
- What is being tested?
- HBM9161 Dose A and HBM9161 Dose B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2020to 11 Aug 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age at the screening visit, male or female.
- Persistent or chronic ITP whose average number of platelet at the screening visit and pre-dose (at least 1 day apart) is < 30 × 10^9/L, and not > 35 × 10^9/L for any of two tests. No severe bleeding within 4 weeks prior to the screening visit.
- Patients who have received and failed at least 1 first line of ITP therapy (glucocorticoids and/or intravenous gamma globulin), or who are contraindicated, intolerable, or refuse standard therapy.
- Patients will be allowed to use a stable dose of concomitant drugs for the treatment of ITP. e.g., glucocorticoid, danazol, immunosuppressant (azathioprine, cyclosporine A, mycophenolate mofetil) and eltrombopag.
Who cannot join
- Other autoimmune systemic diseases other than ITP.
- Multi-lineage immune cytopenias, such as Evan's syndrome, autoimmune pancytopenia.
- Secondary ITP.
- Received a vaccine within 4 weeks prior to the first dose of the study drug or planned during the study.
- Use of anticoagulants or any agents that have antiplatelet effect or can affect thrombopoiesis within 3 weeks prior to the first dose of the study drug.
- Received blood transfusion within 1 week prior to the first dose of the study drug.
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- Received the intravenous gamma globulin, anti-D immunoglobulin, or plasmapheresis within 2 weeks prior to the first dose of the study drug.
- Received high-dose dexamethasone or high-dose methylprednisolone within 2 weeks prior to the first dose of the study drug.
- Received recombinant human thrombopoietin (rhTPO) within 4 weeks prior to the first does of the study drug.
- Received rituximab or other non-rituximab anti-CD20 drugs within 6 months prior to the first does of the study drug.
- Treated with splenectomy within 4 weeks prior to first dose of the study drug.
- Any thromboembolic or embolic events within 12 months prior to the first does of the study drug.
- Serum total IgG < 700 mg/dL at the screening visit.
Trial locations and contacts
1 site in 1 country.
China1 site
Hematology hospital, Chinese academy of medical sciences
Tianjin, Tianjin Municipality, 300020
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Designed Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Weekly Subcutaneous Injection in Patients With Primary Immune Thrombocytopenia
To select a dose and to make a decision for Phase 3 study
Read the detailed description
The onset of primary immune thrombocytopenia is thought to be increased platelet destruction and decreased platelet production due to anti-platelet antibodies. HBM9161 is a fully human anti-FcRn monoclonal antibody that can effectively remove pathogenic IgG, thereby relieving platelet destruction and rapidly increasing platelet counts in patients. The study will be conducted in a Phase 2/3 operational seamless design, with group Dose A and Dose B of HBM9161 and a placebo group in Phase 2.
- Conditions
- Primary Immune Thrombocytopenic Purpura
- Being tested
- HBM9161 Dose A, HBM9161 Dose B, Placebo
- Keywords
- ITP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBM9161 Dose ADrug
HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
HBM9161 Dose BDrug
HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
PlaceboDrug
HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
| Study group | Role | What they receive |
|---|---|---|
| HBM9161 Dose A | Experimental | Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo Receives: Drug: HBM9161 Dose A |
| HBM9161 Dose B | Experimental | Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo Receives: Drug: HBM9161 Dose B |
| Placebo | Placebo comparator | Patients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieve the early response.
The primary endpoint of phase 2
Measured: 7 weeks
Secondary outcomes (1)
Proportion of patients who achieve platelet count ≥ 50 × 10^9/L at least 2 times within 7 weeks.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start24 Jul 2020
- Primary completion10 Aug 2021
- Study completion11 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renchi Yang, Principal investigator, Hematology hospital, Chinese academy of medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428255
- Sponsor's protocol ID
- 9161.4
- Status last verified
- Aug 2021
- First submitted
- 9 Jun 2020
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Designed Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Weekly Subcutaneous Injection in Patients With Primary Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT04428255
- Acronym / sponsor ID
- 9161.4
- Conditions
- Primary Immune Thrombocytopenic Purpura
- Keywords
- ITP
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To select a dose and to make a decision for Phase 3 study
Detailed description
The onset of primary immune thrombocytopenia is thought to be increased platelet destruction and decreased platelet production due to anti-platelet antibodies. HBM9161 is a fully human anti-FcRn monoclonal antibody that can effectively remove pathogenic IgG, thereby relieving platelet destruction and rapidly increasing platelet counts in patients. The study will be conducted in a Phase 2/3 operational seamless design, with group Dose A and Dose B of HBM9161 and a placebo group in Phase 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HBM9161 Dose A | Experimental | Drug: HBM9161 Dose APatients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo |
| HBM9161 Dose B | Experimental | Drug: HBM9161 Dose BPatients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo |
| Placebo | Placebo comparator | Drug: PlaceboPatients will be randomized in a 1:1:1 ratio to HBM9161 (Dose A or Dose B) or placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age at the screening visit, male or female.
- Persistent or chronic ITP whose average number of platelet at the screening visit and pre-dose (at least 1 day apart) is < 30 × 10^9/L, and not > 35 × 10^9/L for any of two tests. No severe bleeding within 4 weeks prior to the screening visit.
- Patients who have received and failed at least 1 first line of ITP therapy (glucocorticoids and/or intravenous gamma globulin), or who are contraindicated, intolerable, or refuse standard therapy.
- Patients will be allowed to use a stable dose of concomitant drugs for the treatment of ITP. e.g., glucocorticoid, danazol, immunosuppressant (azathioprine, cyclosporine A, mycophenolate mofetil) and eltrombopag.
Key exclusion criteria (13 listed)
- Other autoimmune systemic diseases other than ITP.
- Multi-lineage immune cytopenias, such as Evan's syndrome, autoimmune pancytopenia.
- Secondary ITP.
- Received a vaccine within 4 weeks prior to the first dose of the study drug or planned during the study.
- Use of anticoagulants or any agents that have antiplatelet effect or can affect thrombopoiesis within 3 weeks prior to the first dose of the study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBM9161 Dose AHBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly | Drug | HBM9161 Dose A |
| HBM9161 Dose BHBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly | Drug | HBM9161 Dose B |
| PlaceboHBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly | Drug | Placebo |
Primary outcome
Proportion of patients who achieve the early response.
Time frame: 7 weeks
The primary endpoint of phase 2
1 secondary outcome
Proportion of patients who achieve platelet count ≥ 50 × 10^9/L at least 2 times within 7 weeks.
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renchi Yang principal investigator
Hematology hospital, Chinese academy of medical sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HBM9161 Dose A and HBM9161 Dose B in people with Primary Immune Thrombocytopenic Purpura, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who achieve the early response. (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.