Phase
Condition
Dysfunctional Uterine Bleeding
Thrombosis
Myelodysplastic Syndromes (Mds)
Treatment
MegaLT injection
Clinical Study ID
Ages 4-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age between 4 and 75 years (inclusive) at screening; gender is not restricted;
Diagnosed with refractory thrombocytopenia following radiotherapy/chemotherapy ortransplantation;
Adequate organ function:Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) < 2.5upper limit of normal (ULN); Serum creatinine < 1.5 ULN; Totalbilirubin level < 1.5* ULN; Coagulation function: International Normalized Ratio (INR) ≤ 1.5* ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5*ULN; Hemoglobin ≥ 60 g/L, or hemoglobin maintained at this level after transfusion; Absoluteneutrophil count (ANC) ≥ 1.0×10^9/L;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Voluntarily participating in the clinical trial, with full understanding of thetrial details and having signed the informed consent form.
Exclusion
Exclusion Criteria:
Patients with any malignant tumor relapse;
Pregnant or breastfeeding women;
Life expectancy less than 3 months;
Severe infections or severe concurrent conditions such as heart, liver, lung,kidney, neurological, or metabolic diseases;
History of severe thrombotic events or known thrombotic risk factors. Exceptions:Participants for whom the potential benefits of the study, as determined by theinvestigator, outweigh the potential risks of thromboembolic events;
Uncontrolled infectious or other serious diseases, including but not limited toinfections (e.g., HIV positive), congestive heart failure, unstable angina,arrhythmias, psychiatric disorders, or conditions that limit the ability to meetstudy requirements or pose unpredictable risks as judged by the primary physician;
Active hepatitis B or C infection;
Refractory thrombocytopenia post-transplant with Grade III-IV acutegraft-versus-host disease (GVHD) [according to NIH standards] or severe chronic GVHD (NIH 2014 standards);
History of organ transplantation or planned organ transplantation (excludinghematopoietic stem cell transplantation);
Participation in another clinical study within 30 days prior to the baseline visit,involving any investigational drug or device; observational studies are allowed;
Any other conditions deemed by the investigator to make the participant unsuitablefor the clinical trial.
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui 230036
ChinaActive - Recruiting
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