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A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease

RecruitingPhase 2Ages 18 Years - 70 YearsAllChia Tai Tianqing Pharmaceutical Group Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Voluntary and signed informed consent, good compliance; * Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months. * Received allogeneic hematopoietic stem cell transplantation; * Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD) * Received systemic therapies for cGVHD; * Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening; * Absolute Neutrophil Count (ANC) ≥ 1.0×10 9/L ;platelet count (PLT) ≥30×10 9 /L; Hemoglobin ≥80g/L; There were no obvious abnormalities in liver and kidney function and coagulation function; * Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study Exclusion Criteria: * Currently present or occured other malignancies within 3 years prior to first administration; * Known or suspected active acute graft versus host disease (aGVHD); * Presence of infection requiring treatment within 7 days prior to randomization; * Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants; * Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization; * Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc; * Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder; * Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment; * Have any severe or uncontrolled serious illness, including but not limited to,uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment; * Those who are allergic to the study drug or its components; * Participation in other clinical trials or major surgery within 4 weeks prior to the first dose; * Subjects judged by the investigator to be unsuitable for enrollment;
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What it tests

  • TQ05105 tablets
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Where

12 sites
Anhui Provincial Hospital
Hefei, China
The 940th hospital of joint logistics support force of Chinese people's liberation army
Lanzhou, China
Guangzhou First People's Hospital
Guangzhou, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Xiangyang Central Hospital
Xiangyang, China
Tai'an Central Hospital
Taian, China
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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