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Compares treatment options for Primary Immune Thrombocytopenia
Official title A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia
ClinicalTrials.gov ID: NCT06900920
What this study is testing
What is TQB3473 Tablets?
TQB3473 Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for primary 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
- This is a randomized, double-blind, placebo-controlled Phase III clinical study designed to demonstrate that TQB3473 tablets significantly improve the sustained response rate compared to placebo in adult patients with chronic ITP who have previously received standard corticosteroid therapy and have failed or relapsed after at least one standard ITP treatment. The study consists of a treatment period and a safety follow-up period.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people voluntarily join this study, sign the informed consent form (ICF), and demonstrate good compliance;
- Male or female people aged 18 to 75 years (calculated based on the date of signing the informed consent form);
- Eastern Cooperative Oncology Group (ECOG) score of 0-1;
- Diagnosis of primary ITP prior to randomization, with a duration of ≥12 months;
- An average of at least three independent platelet counts (spaced more than 3 days apart) within the 3 months prior to randomization \ 35×10\^9/L; and...
You likely can't join if
- Evidence of secondary causes of ITP (e.g., untreated Helicobacter pylori infection, leukemia, lymphoma, history of autoimmune diseases such as...
- people with a history or current diagnosis of myelofibrosis, myelodysplastic syndrome, aplastic anemia, lymphoproliferative disorders, or other...
- History of or concurrent other malignancies within the past 3 years. Exceptions include: other malignancies treated with a single surgical procedure...
- Conditions affecting venous blood sampling or multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhea, intestinal...
- Adverse reactions from previous treatments have not resolved to ≤CTCAE grade 1, except for non-clinically significant and asymptomatic laboratory...
- Previous bone marrow/hematopoietic stem cell transplantation or major solid organ transplantation;
See the full eligibility criteria
- people voluntarily join this study, sign the informed consent form (ICF), and demonstrate good compliance;
- Male or female people aged 18 to 75 years (calculated based on the date of signing the informed consent form);
- Eastern Cooperative Oncology Group (ECOG) score of 0-1;
- Diagnosis of primary ITP prior to randomization, with a duration of ≥12 months;
- An average of at least three independent platelet counts (spaced more than 3 days apart) within the 3 months prior to randomization \ 35×10\^9/L; and no severe bleeding within 4 weeks prior to screening;
- Previous treatment with glucocorticoids and at least one standard ITP therapy that was ineffective or resulted in relapse.
- Female people of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of study treatment, with a negative serum or urine pregnancy test within 7 days prior to...
- Evidence of secondary causes of ITP (e.g., untreated Helicobacter pylori infection, leukemia, lymphoma, history of autoimmune diseases such as systemic lupus erythematosus, Hashimoto's thyroiditis, etc.) or drug-induced...
- people with a history or current diagnosis of myelofibrosis, myelodysplastic syndrome, aplastic anemia, lymphoproliferative disorders, or other malignant hematologic diseases;
- History of or concurrent other malignancies within the past 3 years. Exceptions include: other malignancies treated with a single surgical procedure and achieving continuous 5-year disease-free survival (DFS); cured...
- Conditions affecting venous blood sampling or multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Adverse reactions from previous treatments have not resolved to ≤CTCAE grade 1, except for non-clinically significant and asymptomatic laboratory abnormalities judged by the investigator to pose no safety risks;
- Previous bone marrow/hematopoietic stem cell transplantation or major solid organ transplantation;
- Vaccination within 8 weeks prior to randomization or planned vaccination during the study period;
- Major surgical treatment or significant traumatic injury within 4 weeks prior to randomization, or anticipated need for major elective surgery during the study treatment period (major surgery is defined as level 3 or...
- History of intracranial hemorrhage or other severe bleeding in vital organs (≥CTCAE grade 3), or symptomatic gastrointestinal bleeding (e.g., hematemesis, melena, etc., excluding asymptomatic "occult blood test...
- Arterial/venous thrombotic events within 12 months prior to randomization, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism;
- ITP-related symptoms and treatments:
- Receipt of immunoglobulins or platelet transfusions within 2 weeks prior to randomization;
- Receipt of treatments aimed at increasing platelet counts (including but not limited to glucocorticoids, Thyroid peroxidase (TPO), Thrombopoietin receptor agonists (TPO-RAs), cyclosporine, herbal medicines, etc.) within...
- Use of rituximab or other anti-cluster of differentiation 20 (CD20) drugs within 14 weeks prior to randomization;
- Splenectomy within 12 weeks prior to randomization.
- Need for long-term/continuous use of medications affecting platelet function [including but not limited to aspirin, clopidogrel, ticagrelor, non-steroidal anti-inflammatory drugs (NSAIDs), etc.] or anticoagulant therapy;
- Known allergy to the active ingredient or excipients of the investigational drug;
- Previous treatment with Syk inhibitors;
- Participation in another clinical trial and use of investigational drugs within 4 weeks prior to randomization;
- Any condition judged by the investigator to pose a significant risk to the subject's safety or to affect the subject's ability to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Wuhu, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Zhanjiang, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Haikou, Hainan, China
- Baoding, Hebei, China
- Chengde, Hebei, China
- Shijiazhuang, Hebei, China
- Tangshan, Hebei, China
- Harbin, Heilongjiang, China
- Anyang, Henan, China
- Nanyang, Henan, China
- Xuchang, Henan, China
- Zhengzhou, Henan, China
+ 22 more site(s).
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Wuhu, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China and 36 more location(s). 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.