|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00909077 |
|
Date of registration:
|
26/05/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)
|
|
Scientific title:
|
A Randomised Phase III Study of the Efficacy of High Dose Dexamethasone Versus High Dose Dexamethasone in Combination With Rituximab (MabThera®)in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP) |
|
Date of first enrolment:
|
August 2004 |
|
Target sample size:
|
155 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00909077 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Hans C Hasselbalch, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Copenhagen University Hospital Herlev, Department of Haematology |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age 18 years or over
- Diagnosis = ITP + platelet count above or equal to 25 Mia/l or platelet count above or
equal to 50 Mia/l and bleeding from the mucous membranes.
- Adequate contraceptive measures within the last 3 months for women of childbearing
potential.
Exclusion Criteria:
- Performance status above or equal to 2
- Previous treatment with rituximab
- Immunosuppressive treatment within the last month except for not previously treated
patients
- Other serious disease
- Pregnant women and nursing mothers
- Contraindication for rituximab treatment.
- Active infection requiring antibiotic treatment.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Idiopathic Thrombocytopenic Purpura
|
|
Intervention(s)
|
|
Drug: Dexamethasone and Rituximab
|
|
Drug: Dexamethasone
|
|
Primary Outcome(s)
|
|
Number of patients with sustained partial response after 6 months
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Remission rates in the 2 arms at day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5
[Time Frame: day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5]
|
|
Secondary ID(s)
|
|
ITP-Rituximab-DXM
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|