CompletedPhase 2/3

A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP

China36 participantsStarted 2020-07-24

Plain-language summary

To select a dose and to make a decision for Phase 3 study

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥ 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.

✕. 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.
✕. 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.

Proportion of patients who achieve the early response.

Timeframe: 7 weeks

NCT IDNCT04428255

SponsorHarbour BioMed (Guangzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-10

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥ 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.

✕. 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.
✕. 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.