Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)
NCT ID: NCT06594146
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
62 participants
INTERVENTIONAL
2024-11-11
2025-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Prospective, One-arm and Open Clinical Study of CM313 in the Treatment of Immune Thrombocytopenia
NCT05694767
A Randomized, Double-blind, Placebo-controlled, and Multi-center Clinical Study of CM313 in the Treatment of Immune Thrombocytopenia
NCT06199089
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP
NCT03102593
Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
NCT04089267
Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
NCT02868060
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
CM313 injection and placebo
CM313 injection
CM313
placebo
placebo
Group 2
CM313 injection and placebo
CM313 injection
CM313
placebo
placebo
Group 3
CM313 injection and placebo
CM313 injection
CM313
placebo
placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CM313 injection
CM313
placebo
placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Fully understand and are able to comply with the requirements of the protocol and voluntarily sign the informed consent form.
Exclusion Criteria
* Laboratory abnormalities with clinical significance at screening visit.
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeeding during the study period; Male partners who plan to become pregnant during the study period.
* With any other situations that are not suitable for participation in this study by the investigator.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lei Zhang
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Hematology & Blood Diseases Hospital
Tianjin, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CM313-111101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.