Overview

Treatment of ITP With Rituximab and / or Accutane

Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
Summary
a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University People's Hospital
Collaborator:
Beijing Hospital
Treatments:
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Rituximab
Criteria
Inclusion Criteria:

1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed

2. Platelet count less than 30×109/L on two occasions or Platelets above 30×109/L
combined with bleeding manifestation

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