Ripertamab Plus Eltrombopag vs. Eltrombopag in ITP Patients Post-Steroid Failure

NCT06790888 | Not Yet Recruiting DMC

• 1 other identifier: UHCT240527
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ITP - Immune Thrombocytopenia

Keywords

Ripertamab

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 12weeks

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  through study completion, an average of 1 year

• Complete Response Rate (CR%)

  through study completion, an average of 1 year

• Median Time to Response (mTTR)

  1 year

• Median Sustained Response Time (mSRT)

  1 year

• 24-week Sustained Response Rate (24-week SR)

  up to 24 weeks

Study Arms (2)

Eltrombopag/Ripertamab

EXPERIMENTAL

Eltrombopag (starting at 2.5mg once daily, 28 days, adjusted based on platelet count),Ripertamab (375 mg/m² BSA on Day 1)，If the participant remains in remission at the 3-month, an additional intravenous dose of 375 mg/m² BSA Ripertamab is administered

Combination Product: Ripertamab/Eltrombopag

Eltrombopag

ACTIVE COMPARATOR

Eltrombopag (starting at 2.5mg once daily, 28 days, adjusted based on platelet count)

Drug: Eltrombopag

Interventions

Ripertamab/Eltrombopag COMBINATION_PRODUCT

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.

Also known as: Anti-CD20/TPO-RA

Eltrombopag/Ripertamab

Eltrombopag DRUG

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.

Also known as: TPO-RA

Eltrombopag

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis: Confirmed Primary Immune Thrombocytopenia (ITP) with an age range of 18 to 80 years, inclusive, and no gender restrictions.
• Bone Marrow Cytology: Diagnosis via bone marrow cytology excluding secondary thrombocytopenia caused by other diseases, with primary ITP patients who are unresponsive to or have relapsed after first-line steroid therapy (platelet count drops below 30×10\^9/L).
• Coagulation Status: Laboratory tests show prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) not exceeding 20% above the upper limit of normal values, with no history of coagulation disorders other than ITP.
• Bone Marrow Function: Normal bone marrow function indicated by an absolute neutrophil count (ANC) ≥1.5×10\^9/L and hemoglobin (Hb) ≥90 g/L.
• Liver and Kidney Function: Normal liver and kidney function with serum direct bilirubin and indirect bilirubin ≤1.5 times the upper limit of normal (ULN); 5.alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); serum creatinine ≤1.5 times the upper limit of normal (ULN).
• Psychiatric History: No history of psychiatric disorders. 7.Informed Consent: Voluntary signing of an informed consent form.

You may not qualify if:

• Life-Threatening Bleeding: Presence of bleeding that poses an immediate threat to life, such as severe anemia or central nervous system bleeding.
• Recent Treatment: Use of intravenous immunoglobulin, thrombopoietin receptor agonists, recombinant human thrombopoietin (rhTPO), immunosuppressants, anti-CD20 monoclonal antibodies, or systemic corticosteroids within 28 days prior to enrollment.
• Malignancy History: History of malignancy.
• Cardiac Conditions: Presence of severe heart failure or other diseases significantly impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, arrhythmias, or prolonged QTc interval within the last 3 months).
• Coagulation Disorders: History of coagulation disorders other than ITP, such as disseminated intravascular coagulation (DIC), hemolytic uremic syndrome (HUS), or thrombotic thrombocytopenic purpura (TTPP).
• Viral Markers: Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test ≥10\^4 copies/mL; or Hepatitis B virus (HBV) markers positive for HBsAg and/or HBcAb with HBV DNA positivity.
• Immunocompromised: History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, autoimmune diseases, or a history of organ transplantation.
• Tuberculosis: Suspected active or latent tuberculosis.
• Active Infections: Presence of active infections at enrollment, or any significant infectious events within 4 weeks prior to enrollment or major surgery within 4 weeks.
• Pregnancy and Lactation: Pregnant or nursing women, or women of childbearing potential or considering pregnancy during the study period.
• Other Conditions: Any other conditions deemed by the investigator as contraindications for study participation.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Sinocelltech Ltd.: collaborator

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Heng MEI, Ph.D&M.D

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Heng Mei, Ph.D&M.D

CONTACT

027-8572600; hmei@hust.edu.cn

QZ Wei, Ph.D.

CONTACT

15271897896; 576346468@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 24, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share