Combining low-dose Baricitinib with Danazol for treating immune thrombocytopenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial investigates the effectiveness and safety of combining low-dose baricitinib with danazol in adults suffering from steroid-resistant or relapsed immune thrombocytopenia (ITP). A total of 216 patients will be randomly assigned to receive either the combination therapy or danazol alone for a duration of six months. The primary goal is to achieve a durable response, defined by specific platelet count criteria and the absence of bleeding. The study is conducted across multiple centers in China to ensure a diverse patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
2. Patients with chronic low platelet count (\<30,000/μL) for 6 months who have failed at least one treatment for chronic low platelet count;
3. Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
4. Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with clinically significant bleeding symptoms at the enrollment;
5. Willing and able to provide written informed consent, and agreeable to the schedule of assessment.

Exclusion Criteria:

1. Secondary immune thrombocytopenia (e.g. patients with HIV, HCV, Helicobacter pylori infection or patients with confirmed autoimmune disease);
2. Active or a history of malignancy;
3. Pregnancy or lactation;
4. Current or recent (\<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection;
5. A history of symptomatic herpes zoster infection within 12 weeks prior to screening;
6. Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
7. Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB;
8. Have experienced a clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled;
9. Myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure;
10. A history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data;
11. Any of the following specific abnormalities on screening laboratory tests:

1) ALT or AST \>2 x ULN, or total bilirubin ≥1.5 x ULN 2) hemoglobin \<9 g/dL, or total white blood cell (WBC) count \<2,500/µL, or neutropenia (absolute neutrophil count \<1,200/µL), or lymphopenia (lymphocyte count \<750/µL) 3) eGFR \<50 mL/min/1.73 m\^2.

Where it's running

• Peking University Insititute of Hematology, Peking University People's Hospital
  Beijing, Beijing, China Recruiting
• Beijing Friendship Hospital
  Beijing, China Recruiting
• Beijing Hospital
  Beijing, China Recruiting
• Beijing Luhe Hospital
  Beijing, China Recruiting
• Beijing Tsinghua Changgeng Hospital
  Beijing, China Recruiting
• China-Japan Friendship Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Xiaohui Zhang, MD — Peking University Institute of Hematology, Peking University People's Hospital
• Study coordinator: Xiaohui Zhang, MD
• Email: Zhangxh@bjmu.edu.cn
• Phone: +8610-8832-4672

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Safety and drug level study of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adults

  This early-phase study tests how different doses of upadacitinib, tofacitinib, and baricitinib behave in healthy adults to understand safety and how the drugs act in the body.

  Recruiting Phase 1 AbbVie · Grayslake, Illinois · NCT07843693

• Sirolimus added to standard therapy for adults with SLE-associated immune thrombocytopenia

  This trial tests whether adding sirolimus to usual treatment helps adults with SLE-related immune thrombocytopenia see their platelet counts improve.

  Recruiting Phase 2/3 Chinese SLE Treatment And Research Group · Beijing, Beijing Municipality · NCT07657793

• GL-2045 safety and blood-count help for adults with ITP

  GL-2045 is being tested in adults with immune thrombocytopenia to see if it can safely raise platelet counts like IVIg does.

  Recruiting Phase 1 Gliknik Inc. · Leeds · NCT07605845

• Eltrombopag use in adults with primary ITP: real-world patterns and outcomes

  This study looks at how eltrombopag is used in adult patients with primary ITP and what outcomes are seen in routine care.

  Recruiting Novartis · Basel · NCT07587723

• Baricitinib for persistent low platelets after stem cell transplant

  We’re testing baricitinib to see if it can help people with long-term low platelets after an allogeneic stem cell transplant who didn’t respond to other treatments.

  Recruiting Phase 1/2 Peking University People's Hospital · Beijing, Beijing Municipality · NCT07535645

• Telitacicept plus baricitinib for refractory rheumatoid arthritis

  This test tries combining telitacicept with baricitinib to see if it helps adults with refractory rheumatoid arthritis who haven't improved on other treatments.

  Recruiting Zhejiang Provincial People's Hospital · Hangzhou, Zhejiang · NCT07491016

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.