TPO-RA Plus Baricitinib vs. TPO-RA for ITP

NCT07669675 | Not Yet Recruiting Phase 2

• 1 other identifier: SEN-TPO
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ITP - Immune Thrombocytopenia

Keywords

immune thrombocytopenia; baricitinib; TPO-RA

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 14 days

Secondary Outcomes (7)

• 14-day Complete response (CR) rate

  From enrollment to the end of treatment at 14 days

• 28-day ovrall response rate

  From enrollment to the end of treatment at 28 days

• 28-day CR rate

  From enrollment to the end of treatment at 28 days

• Time to response (TTR)

  From the start of study treatment (Day 1) up to day 14

• Bleeding events

  From the start of study treatment (Day 1) to the end of day 14

Study Arms (2)

Combined therapy

EXPERIMENTAL

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

Monotherapy

ACTIVE COMPARATOR

Prior full-dose TPO-RA (hetrombopag 7.5mg once daily or eltrombopag 75mg once daily) was continued.

Drug: TPO-RA

Interventions

Baricitinib DRUG

Oral baricitinib is given at a dose of 2 mg twice daily for 14 days.

Combined therapy

TPO-RA DRUG

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

Combined therapy; Monotherapy

Eligibility Criteria

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

You may qualify if:

• ≥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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

baricitinib; hetrombopag; 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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-02