About this trial
This study is an extension of the TQB3473-III-01 study, aimed at evaluating the safety and efficacy of TQB3473 tablets in adult patients with persistent or chronic ITP who have received at least one ITP standard treatment that is ineffective or has recurred after treatment. This is a single arm, open label, multi cohort, multi center Phase II clinical study.
Eligibility criteria
Qualifiers
Voluntarily participate in this study with signed informed consent form (ICF) and demonstrated good compliance.
Age ≥18 years (calculated from the date of ICF signing); no gender restrictions; Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Clinically stable condition with WHO bleeding scale score 0-1, and investigator assessment indicates no need for emergency treatment within the next 2 weeks.
No increase in the type, dosage, or frequency of concomitant ITP medications compared to the TQB3473-III-01 study regimen.
Disqualifiers
Due to reasons other than lack of efficacy, receiving TQB3473-III-01 study treatment for less than 12 weeks.
Hepatitis B Virus (HBV) DNA or Hepatitis C Virus (HCV) RNA detection values exceeding the upper limit of normal or decompensated cirrhosis
Previous intracranial hemorrhage or severe bleeding of other important organs (≥ CTC AE grade 3), or symptomatic gastrointestinal bleeding (such as vomiting blood, black stool, etc., except for asymptomatic and asymptomatic "occult blood test positive" and hemorrhoids) within the 6 months before enrollment.
Suffering from major cardiovascular and cerebrovascular diseases.
Trial design
Treatments tested in this trial
- TQB3473 Tablets