A Study on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Treatment groups

320 Participants
are divided into 1 treatment group