A Phase 2 interventional study of Baricitinib and TPO-RA in ITP - Immune Thrombocytopenia, sponsored by Peking University People's Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
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.
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.
517 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 161 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 381 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Browse Purpura, Thrombocytopenic, Idiopathic studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
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Exclusion Criteria:
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).
Drug: Baricitinib · Drug: TPO-RA
Prior full-dose TPO-RA (hetrombopag 7.5mg once daily or eltrombopag 75mg once daily) was continued.
Drug: TPO-RA
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
Also known as: hetrombopag, eltrombopag
14-day Overall response rate
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.
Time frame: From enrollment to the end of treatment at 14 days
14-day Complete response (CR) rate
Complete response (CR) was defined as platelet count over 100,000/μL and absence of bleeding.
Time frame: From enrollment to the end of treatment at 14 days
28-day ovrall response rate
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.
Time frame: From enrollment to the end of treatment at 28 days
28-day CR rate
Complete response (CR) was defined as platelet count over 100,000/μL and absence of bleeding.
Time frame: From enrollment to the end of treatment at 28 days
Time to response (TTR)
The time from treatment initiation to achieve a CR or a R.
Time frame: From the start of study treatment (Day 1) up to day 14
Bleeding events
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).
Time frame: From the start of study treatment (Day 1) to the end of day 14
Health-related quality of life (HRQoL)
ITP-patient assessment questionnaire was used to assess the HRQoL before and after treatment.
Time frame: From the start of study treatment (Day 1) to the end of day 14
AE
Adverse events
Time frame: From enrollment to the end of treatment at 14 days
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital