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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

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:

  1. ≥18 years old;
  2. Patients diagnosed with primary ITP who failed to achieve a response after 14 days of full-dose TPO-RA therapy;
  3. 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:
  • eltrombopag
  • hetrombopag
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:
  • eltrombopag
  • hetrombopag

¿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.

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

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.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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