Combining Hetrombopag with Dexamethasone for Treating Newly Diagnosed Immune Thrombocytopenia
High-dose Dexamethasone Plus Hetrombopag Versus High-dose Dexamethasone Alone as Frontline Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia (ITP):A Prospective Multicenter Randomized Trial
This study is testing if combining hetrombopag with high-dose dexamethasone can help adults who are newly diagnosed with immune thrombocytopenia have better platelet counts and fewer bleeding symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shandong University Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Dongying, Shandong) |
| Trial ID | NCT05943691 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of hetrombopag combined with high-dose dexamethasone in adults newly diagnosed with primary immune thrombocytopenia (ITP). A total of 100 participants will be randomly assigned to receive either the combination treatment or high-dose dexamethasone alone. The treatment involves administering hetrombopag at a starting dose of 5 mg daily for 8 weeks, with adjustments based on platelet counts, alongside a 4-day course of dexamethasone. The study aims to evaluate platelet counts, bleeding symptoms, and adverse events throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with newly diagnosed immune thrombocytopenia and specific platelet count criteria.
Not a fit: Patients with secondary thrombocytopenia, recent thromboembolism, or significant liver or kidney dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for managing newly diagnosed ITP, potentially improving patient outcomes.
How similar studies have performed: While this approach is novel in combining hetrombopag with high-dose dexamethasone, similar studies have shown promise in treating ITP with other therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Older than 18 years * Meet the diagnostic criteria for newly diagnosed immune thrombocytopenia (diagnosed within 3 month); * platelet count \<30\*10\^9/L, or \< 50\*10\^9/L with bleeding manifestations, both; * Willing and able to sign written informed consent Exclusion Criteria: * secondary thrombocytopenia or graded MF≥2 myelofbrosis based on the European Consensus Scale * Previous history of treatment for ITP, except Platelet transfusion, ITP-directed Prednisone therapy no more than 2 weeks or TPO therapy no more than 1 week and stopped ≥1 week before randomization * No response to TPO-RA or rhTPO * HIV, hepatitis C or B virus infection * pregnancy or lactation; * arterial or venous thromboembolism within the 6 months before screening * total bilirubinalanine, aminotransferase or aspartate transaminase\>3×upper limit of normal (ULN), serum creatinine\>1.5×ULN * congestive heart failure (New York Heart Association \[NYHA\] class III/IV); * neoplastic disease within the past 5 years; * liver cirrhosis * people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.
Where this trial is running
Dongying, Shandong
- Shengli Oilfield Central Hospital — Dongying, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Yan Shi
- Email: shiyansjj@163.com
- Phone: 8682169896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.