Immune Thrombocytopenia
Conditions
Keywords
immune thrombocytopenia, acetylcysteine
Brief summary
A single-arm, open-label study to evaluate the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia (ITP).
Detailed description
This is a prospective, open-label, Phase II, single-arm interventional trial performed in a single center in China. The investigators explore the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia.
Interventions
DRUGDexamethasone
Dexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated on days 11 to 14 in the case of lack of response by day 10)
DRUGAcetylcysteine
Acetylcysteine, po, 400mg tid, for 4 weeks
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed 2. Platelet count less than 30×10\^9/L on two occasions or Platelets above 30×10\^9/L combined with bleeding manifestation (WHO bleeding scale 2 or above) 3. Subject is ≥ 18 years and ≤80years 4. Subject has signed and dated written informed consent. 5. Fertile patients must use effective contraception during treatment and observational period 6. Negative pregnancy test
Exclusion criteria
1. Have an impaired renal function as indicated by a serum creatinine level \> 2.0 mg/dL 2. Have an inadequate liver function as indicated by a total bilirubin level \> 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level \> 3×upper limit of normal 3. Have a New York Heart Classification III or IV heart disease 4. Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures 5. Have active hepatitis B or hepatitis C infection 6. Have a HIV infection 7. Have active infection requiring antibiotic therapy within 7 days prior to study entry 8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug 9. Previous treatment with rituximab 10. Previous splenectomy 11. Had previous or concomitant malignant disease 12. Not willing to participate in the study. 13. Expected survival of \< 2 years 14. Intolerant to murine antibodies 15. Immunosuppressive treatment within the last month 16. Connective tissue disease 17. Autoimmune hemolytic anemia 18. Patients currently involved in another clinical trial with evaluation of drug treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with durable response after 6 months | 6 months | Number of patients with durable response after 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial response | 1 month | Number of patients with initial response at 1 month |
| Bleeding | 1 year | Number of patients with bleeding complication therapy; bleeding score |
| Early response | 7 days | Number of patients with early response on day 7 |
| Relapse | 1 year | Number of patients relapse during the observation |
| Adverse events | 1 year | Number of patients with adverse events |
| DOR | 1 year | duration of response |
Countries
China
Contacts
Primary ContactXiaohui Zhang, MD
Backup ContactXinglin Wang, MD
Outcome results
None listed