- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07669675
TPO-RA Plus Baricitinib vs. TPO-RA for ITP
20 de junio de 2026 actualizado por: Fu Haixia, Peking University People's Hospital
TPO-RA Plus Baricitinib vs. TPO-RA in Patients With ITP : A Randomized, Open-label Trial
This is a prospective, randomized, controlled trial.
ITP patients who failed prior full-does TPO-RA monotheray for 14 days.
Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone.
Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone.
The primary endpoint was the 14-day overall response rate without any rescue therapy.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, randomized, controlled trial.Eligible patients were at least 18 years old, had a diagnosis of primary ITP and did not respond after receiving TPO-RA (hetrombopag or eltrombopag) at the full dose (hetrombopag 7.5mg per day or eltrombopag 75 mg per day) for 14 days (platelet count below 30×10^9/L or a value less than a 2-fold increase from their baseline platelet count).
Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone.
Both groups will continue their prior full-dose TPO-RA therapy for 14 days (day 1-14), while baricitinib was given orally at a dose of 2 mg twice daily concomitantly in the combination group for 14 days (day 1-14).
The primary endpoint was the 14-day overall response rate without bleeding and any rescue therapy.
The secondary endpoints included the 28-day overall response rate, 14-day complete response rate, the 28-day complete response rate, time to response, WHO bleeding scores, health-related quality of life, and adverse events.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- Fase 2
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- ≥18 years old;
- Patients diagnosed with primary ITP who failed to achieve a response after 14 days of full-dose TPO-RA therapy;
- Patients with baseline platelet count less than 30×10⁹/L, or those with baseline platelet count ranging from 30×10⁹/L to 50×10⁹/L accompanied by clinically significant bleeding (WHO bleeding score ≥2).
Exclusion Criteria:
- Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;
- With active malignancy or a history of malignant tumor;
- Having experienced severe bacterial, viral, fungal or parasitic infection within the past 4 weeks;
- With a history of symptomatic herpes zoster infection within 12 weeks prior to screening;
- Active or chronic HBV, HCV or HIV infection;
- Evidence of active tuberculosis; or previous evidence of active tuberculosis without appropriate and documented treatment; or household contact with patients with active tuberculosis without appropriate and documented tuberculosis prophylaxis;
- Receipt of live vaccines within the past 12 weeks, or planned live vaccination during the study period;
- Prior baricitinib therapy;
- History of solid organ transplant or planned surgery;
- Myelodysplastic syndrome, aplastic anemia or myelofibrosis;
- Patients with other diseases were undergoing treatment with immunosuppressants;
- Clinically significant thromboembolic events within the past 24 weeks, or ongoing anticoagulant treatment, who are deemed ineligible for the study by the investigator;
- History or presence of myocardial infarction, unstable ischemic heart disease, stroke, or NYHA Class IV heart failure;
- History or active manifestations of severe or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, neuropsychiatric, or other medical conditions that, in the investigator's judgment, could confer unacceptable safety risks with the investigational product or confound the interpretation of study data;
- AST > 2 times the upper limit of normal (ULN), ALT > 2×ULN, TBIL ≥ 1.5×ULN;
- eGFR < 50 mL/min/1.73m²;
- Other patients deemed unsuitable for enrollment in this study by the investigator.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Combined therapy
Oral baricitinib is given at a dose of 2 mg twice daily for 14 days (day 1-14); prior full-dose TPO-RA therapy (hetrombopag 7.5mg once daily or eltrombopag 75mg once daily) was continued for 14 days (day 1-14).
|
Oral baricitinib is given at a dose of 2 mg twice daily for 14 days.
Hetrombopag is given at an initial dose of 7.5 mg once daily for 14 days; eltrombopag is given at an initial dose of 75 mg once daily for 14 days
Otros nombres:
|
|
Comparador activo: Monotherapy
Prior full-dose TPO-RA (hetrombopag 7.5mg once daily or eltrombopag 75mg once daily) was continued.
|
Hetrombopag is given at an initial dose of 7.5 mg once daily for 14 days; eltrombopag is given at an initial dose of 75 mg once daily for 14 days
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
14-day Overall response rate
Periodo de tiempo: From enrollment to the end of treatment at 14 days
|
Overall response was defined as platelet count over 30,000/μL and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy.
|
From enrollment to the end of treatment at 14 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
14-day Complete response (CR) rate
Periodo de tiempo: From enrollment to the end of treatment at 14 days
|
Complete response (CR) was defined as platelet count over 100,000/μL and absence of bleeding.
|
From enrollment to the end of treatment at 14 days
|
|
28-day ovrall response rate
Periodo de tiempo: From enrollment to the end of treatment at 28 days
|
Overall response was defined as platelet count over 30,000/μL and at least a 2-fold increase of the baseline count and absence of bleeding.
|
From enrollment to the end of treatment at 28 days
|
|
28-day CR rate
Periodo de tiempo: From enrollment to the end of treatment at 28 days
|
Complete response (CR) was defined as platelet count over 100,000/μL and absence of bleeding.
|
From enrollment to the end of treatment at 28 days
|
|
Time to response (TTR)
Periodo de tiempo: From the start of study treatment (Day 1) up to day 14
|
The time from treatment initiation to achieve a CR or a R.
|
From the start of study treatment (Day 1) up to day 14
|
|
Bleeding events
Periodo de tiempo: From the start of study treatment (Day 1) to the end of day 14
|
Bleeding was assessed with the WHO bleeding scale (grade 0, no bleeding; grade 1, petechiae; grade 2, mild blood loss; grade 3, gross blood loss; grade 4, debilitating blood loss).
|
From the start of study treatment (Day 1) to the end of day 14
|
|
Health-related quality of life (HRQoL)
Periodo de tiempo: From the start of study treatment (Day 1) to the end of day 14
|
ITP-patient assessment questionnaire was used to assess the HRQoL before and after treatment.
|
From the start of study treatment (Day 1) to the end of day 14
|
|
AE
Periodo de tiempo: From enrollment to the end of treatment at 14 days
|
Adverse events
|
From enrollment to the end of treatment at 14 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
20 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de junio de 2026
Publicado por primera vez (Actual)
25 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de junio de 2026
Última verificación
1 de febrero de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Citopenia
- Procesos Patológicos
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Hemorragia
- Manifestaciones de la piel
- Enfermedades hematológicas
- Trastornos de la coagulación de la sangre
- Trastornos hemorrágicos
- Trastornos de las plaquetas sanguíneas
- Microangiopatías trombóticas
- Púrpura Trombocitopénica
- Púrpura
- Trombocitopenia
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Enfermedades hemic y linfáticas
- Púrpura Trombocitopénica Idiopática
- Eltrombopag
- baricitinib
- hetrombopag
Otros números de identificación del estudio
- SEN-TPO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
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