This study aims to evaluate the efficacy and safety of Ripertamab in combination with Eltrombopag compared to Eltrombopag alone for patients with Primary Immune Thrombocytopenia (ITP) who have not responded to or have relapsed after first-line steroid therapy. Participants will be randomly assigned to one of two treatment groups and followed for 52 weeks to assess response rates and safety.
This is a multicenter, open-label, randomized controlled clinical trial designed to compare the effects of Ripertamab plus Eltrombopag versus Eltrombopag monotherapy in adults with ITP. The study will enroll approximately 78 participants, aged 18 to 80 years, who have had an inadequate response to or relapsed after first-line steroid therapy. The primary outcome measure is the sustained response rate at 12 weeks post-treatment initiation. Secondary outcomes include overall response rate, complete response rate, median time to response, median sustained response time, and safety. Participants will undergo regular blood tests and clinical assessments throughout the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Ripertamab, a novel anti-CD20 monoclonal antibody, in combination with Eltrombopag . Ripertamab is administered intravenously at a dose of 375 mg/m² BSA on Day 1 . If the participant remains in remission at the 3-month mark, an additional intravenous dose of 375 mg/m² Ripertamab is administered. Eltrombopag are given orally at an initial dose of 2.5 mg once daily, with dosage adjustments made every two weeks based on platelet count response, for a total treatment duration of up to Day 28.
Eltrombopag as a single therapy. Eltrombopag is a thrombopoietin receptor agonist given orally at an initial dose of 2.5 mg once daily, with dosage adjustments made every two weeks based on platelet count response, for a total treatment duration of up to Day 28.
Sustained Response Rate at 12 Weeks
The primary outcome measure is the proportion of patients who achieve a sustained response at 12 weeks after the initiation of treatment. A sustained response is defined as a platelet count of ≥30×10\^9/L without bleeding and without the need for rescue therapy.
Time frame: up to 12weeks
Overall Response Rate (ORR)
The percentage of patients who achieve any response (complete or partial) to the treatment as measured by an increase in platelet count from baseline.
Time frame: through study completion, an average of 1 year
Complete Response Rate (CR%)
The proportion of patients who achieve a complete response, defined as a platelet count of ≥100×10\^9/L without bleeding and without the need for rescue therapy.
Time frame: through study completion, an average of 1 year
Median Time to Response (mTTR)
The time at which 50% of the patients achieve a response, measured from the start of treatment until the first evidence of therapeutic effect.
Time frame: 1 year
Median Sustained Response Time (mSRT)
The time at which 50% of the patients maintain a response without relapse, measured from the start of treatment until the response is no longer sustained.
Time frame: 1 year
24-week Sustained Response Rate (24-week SR)
The proportion of patients who maintain a sustained response at 24 weeks post-treatment initiation, defined by a platelet count of ≥100×10\^9/L without bleeding and without rescue therapy.
Time frame: up to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
52-week Sustained Response Rate (52-week SR)
The percentage of patients who continue to show a sustained response at 52 weeks after starting treatment, with platelet counts meeting predefined criteria.
Time frame: up to 52 weeks