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New treatment option for Immune Thrombocytopenia
Official title Phase I Study of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia
ClinicalTrials.gov ID: NCT07206758
What this study is testing
What is SHR-2173 Injection?
SHR-2173 Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for immune thrombocytopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must fully understand the trial content, procedures, and potential adverse reactions, and voluntarily sign a written informed consent...
- Age at signing the ICF must be ≥ 18 years (including the boundary value), regardless of gender.
- Confirmed diagnosis of primary ITP for at least 3 months at screening.
- Previous treatment with corticosteroids.
- At the last ITP treatment, participants experienced loss of remission, no remission, relapse after remission, or intolerance.
You likely can't join if
- Diagnosis of secondary thrombocytopenia or concomitant autoimmune hemolytic anemia
- Received platelet transfusion, whole blood transfusion, plasma exchange, or any other emergency treatment drugs within 14 days prior to the first...
- Received immunosuppressants (other than corticosteroids) such as Janus kinase [JAK] inhibitors or Bruton tyrosine kinase [BTK] inhibitors within...
- Previous treatment with SHR-2173
- Screening prothrombin time or activated partial thromboplastin time outside the normal range; concurrent coagulation disorders and/or receiving...
- History of any thrombotic or embolic events within 12 months prior to the first administration, or clinical symptoms and history suggesting...
See the full eligibility criteria
- Participants must fully understand the trial content, procedures, and potential adverse reactions, and voluntarily sign a written informed consent form (ICF).
- Age at signing the ICF must be ≥ 18 years (including the boundary value), regardless of gender.
- Confirmed diagnosis of primary ITP for at least 3 months at screening.
- Previous treatment with corticosteroids.
- At the last ITP treatment, participants experienced loss of remission, no remission, relapse after remission, or intolerance.
- Platelet count \<30×10⁹/L at screening with clinical assessment indicating treatment necessity
- Participants must have adequate organ function
- Clinically stable condition with World Health Organization (WHO) bleeding scale grade 0-1
- Female participants of childbearing potential or male participants with fertile partners must refrain from sperm/ova donation from ICF signing until 12 weeks after last dose and agree to protocol-specified contraceptive...
- Diagnosis of secondary thrombocytopenia or concomitant autoimmune hemolytic anemia
- Received platelet transfusion, whole blood transfusion, plasma exchange, or any other emergency treatment drugs within 14 days prior to the first infusion of SHR-2173
- Received immunosuppressants (other than corticosteroids) such as Janus kinase [JAK] inhibitors or Bruton tyrosine kinase [BTK] inhibitors within either 5 times the drug elimination half-life or 14 days prior to the...
- Previous treatment with SHR-2173
- Screening prothrombin time or activated partial thromboplastin time outside the normal range; concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medications (e.g., warfarin, clopidogrel...
- History of any thrombotic or embolic events within 12 months prior to the first administration, or clinical symptoms and history suggesting thrombophilia
- Current life-threatening bleeding (related to thrombocytopenia) or expected to require emergency treatment within one week after randomization
- Active viral, bacterial, or other infections (including tuberculosis [TB]) requiring systemic treatment at screening, or SARS-CoV-2 infection during screening, or history of clinically significant recurrent infections
- Received live or attenuated live vaccines within 8 weeks prior to the first administration of SHR-2173, or planned to receive live/attenuated vaccinations during the trial
- Received live or attenuated live vaccines within 8 weeks prior to the first administration of SHR-2173, or planned to receive live/attenuated vaccinations during the trial
- Diagnosis of myelodysplastic syndrome; history of or current malignancy within 5 years prior to screening (except for cured non-melanoma skin cancer, in situ carcinoma [e.g., cervical, breast, bladder, prostate cancer]...
- Previous splenectomy
- Previous allogeneic stem cell or organ transplantation (except for corneal transplantation ≥ 3 months prior to screening); known or suspected history of immunosuppression
- Planned surgery during the dosing period
- Any severe and/or unstable pre-existing medical, psychiatric, or other conditions that the investigator judges may interfere with patient safety, obtaining informed consent, or compliance with study procedures
- Allergic constitution (e.g., allergies to two or more drugs, foods, or pollens) or known hypersensitivity (immediate or delayed) or atopic reactions to the study drug (including excipients, monoclonal antibodies)
- Concurrent participation in other investigational studies within either 30 days prior to enrollment or 5 half-lives of the investigational drug (whichever is longer)
- Females who are lactating or pregnant (positive serum or urine β-human chorionic gonadotropin [hCG]) at screening or on Day 1 of Week 1 prior to administration
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.