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NCT05932524
Low-dose Baricitinib Plus High-dose Dexamethasone as First-line Treatment for Patients With Newly Diagnosed Immune Thrombocytopenia: a Multicenter, Open-label, Randomized, Controlled, Phase 2 Trial
Phase 2 trial testing Baricitinib 2 MG in Immune Thrombocytopenia in 132 participants. Status unknown.
1 June 2024
Quick facts
| Lead sponsor | Peking University People's Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 7 July 2023 |
| Primary completion | 1 June 2024 |
| Estimated completion | 1 June 2025 |
| Sites | 10 locations across China |
Drugs / interventions tested
- Baricitinib 2 MG — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
Conditions studied
- Immune Thrombocytopenia — all drugs for Immune Thrombocytopenia →
Sponsor
Peking University People's Hospital
Who can join
Adults 18 to 70, any sex, with Immune Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Durable response
Time frame: 6 months
The maintenance of a platelet count ≥30,000/μL, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up.
Sponsor's own description
A randomized, open-label, multicenter, phase 2 trial to compare the efficacy and safety of baricitinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05932524
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Baricitinib 2 MG
Trials testing the same drug.
- NCT05827497 — Baricitinib, Methotrexate as Monotherapy or Combination in the Treatment of Rheumatoid Arthritis - an Open Label Randomi · Phase 4 · unknown
- NCT05660655 — Efficacy and Safety of Baricitinib for the Treatment of Moderate to Severe Rheumatoid Arthritis · Phase 4 · completed
- NCT05686746 — Use of Baricitenib to Maintain of Remission · Phase 2, PHASE3 · unknown
- NCT04916756 — A Prospective Pilot Study to Explore Efficacy and Safety of Baricitinib in Active Primary Sjogren's Syndrome Patients · Phase 1, PHASE2 · completed
Other recruiting trials for Immune Thrombocytopenia
Currently open trials in the same condition.
- NCT07104565 — Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Diso · Phase 2 · recruiting
- NCT07007962 — Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed · Phase 3 · recruiting
- NCT07216079 — Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan · Phase 3 · active not recruiting
- NCT06776510 — A Clinical Study of NAD in the Treatment of Immune Thrombocytopenia · Phase 1, PHASE2 · recruiting
- NCT06715215 — Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia · NA · recruiting
Other Peking University People's Hospital trials
Trials by the same sponsor.
- NCT07535645 — Baricitinib for Post-HSCT Persistent Thrombocytopenia · Phase 1, PHASE2 · not yet recruiting
- NCT07516002 — Immunoglobulin Efficacy and Immune Profiling in Antibody Immunodeficiency · not yet recruiting
- NCT07294339 — A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positiv · NA · not yet recruiting
- NCT07500441 — Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML · recruiting
- NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05932524 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University People's Hospital
- Last refreshed: 11 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05932524.
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