TPO-RA Plus Baricitinib vs. TPO-RA for ITP
ConditionITP - Immune Thrombocytopenia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this 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.
Eligibility criteria
Qualifiers
≥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).
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Baricitinib
- TPO-RA
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov