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| Sponsor: | Copenhagen University Hospital at Herlev |
|---|---|
| Information provided by (Responsible Party): | Copenhagen University Hospital at Herlev |
| ClinicalTrials.gov Identifier: | NCT00909077 |
Purpose
In this study we want to investigate if combination therapy with rituximab (R) + dexamethasone (DXM) is superior to monotherapy with DXM in patients with newly diagnosed idiopathic thrombocytopenic purpura (ITP). Before treatment molecular studies - gene expression profiling - are performed to characterize at the molecular level those patients responding adequately to the treatment as compared to those obtaining a minor or no responses.
The hypothesis is that combination therapy is superior to monotherapy as defined above. Using gene expression studies up-front the hypothesis is that this method may be able to predict the response to treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Thrombocytopenic Purpura |
Drug: Dexamethasone Drug: Dexamethasone and Rituximab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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) |
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Combination therapy with Dexamethasone and Rituximab
|
Drug: Dexamethasone and Rituximab
Dexamethasone tablets: 40 mgs/day for four days Rituximab iv 375 mg/m^2 weekly, a total of four times. Administered on day 2 (i.e. the patient has been treated with Dexamethasone for one day)
|
|
Active Comparator: 2
Dexamethasone as monotherapy
|
Drug: Dexamethasone
Dexamethasone tablets: 40 mg/day for four days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Hans C Hasselbalch, MD | +4526223678 | hkhl@regionsjaelland.dk |
| Contact: Morten K Jensen, MD | +4538682964 | mokrje01@heh.regionh.dk |
| Denmark | |
| Aalborg Hospital | Recruiting |
| Aalborg, Denmark, DK-9000 | |
| Contact: Inge Helleberg, MD +4599322352 ihr@rn.dk | |
| Principal Investigator: Inge Helleberg, MD | |
| Copenhagen University Hospital Rigshospitalet | Recruiting |
| Copenhagen, Denmark, DK-2100 | |
| Contact: Lars Kjeldsen, MD +4535451128 lars.kjeldsen@rh.regionh.dk | |
| Principal Investigator: Lars Kjeldsen, MD | |
| Esbjerg Hospital | Recruiting |
| Esbjerg, Denmark, DK-6700 | |
| Contact: Torben Mourits-Andersen, MD +4579182247 torben.mourits-andersen@svs.regionsyddanmark.dk | |
| Principal Investigator: Torben Mourits-Andersen, MD | |
| Copenhagen University Hospital Herlev, Department of Haematology | Recruiting |
| Herlev, Denmark, DK-2730 | |
| Contact: Henrik S Birgens, MD +4544883936 hebi@heh.regionh.dk | |
| Principal Investigator: Morten K Jensen, MD | |
| Regional Hospital Holstebro | Recruiting |
| Holstebro, Denmark, DK-7500 | |
| Contact: Stanislav Pylczynski, MD +4599125000 aspu@ringamt.dk | |
| Principal Investigator: Stanislav Pylczynski, MD | |
| Naestved Hospital | Recruiting |
| Naestved, Denmark, DK-4700 | |
| Contact: Preben Phillip, MD +4555721401 peph@regionsjaelland.dk | |
| Principal Investigator: Preben Phillip, MD | |
| Odense University Hospital | Recruiting |
| Odense, Denmark, DK-5000 | |
| Contact: Henrik Frederiksen, Sen. Reg. + 45 65 41 18 85 henrik.frederiksen@ouh.regionsyddanmark.dk | |
| Principal Investigator: Henrik Frederiksen, Sen. Reg. | |
| Roskilde Hospital | Recruiting |
| Roskilde, Denmark, DK-4000 | |
| Contact: Hans C Hasselbalch, Professor +4526223678 hkhl@regionsjaelland.dk | |
| Principal Investigator: Dorthe Roennov-Jessen, MD | |
| Vejle Hospital | Recruiting |
| Vejle, Denmark, DK-7100 | |
| Contact: Claus Marcher, MD +45 6541 6333 claus.marcher@slb.regionsyddanmark.dk | |
| Principal Investigator: Torben Plesner, MD | |
| Viborg Hospital | Recruiting |
| Viborg, Denmark, DK-8800 | |
| Contact: Herdis Larsen, MD +4589272727 herdis.larsen@viborg.rm.dk | |
| Principal Investigator: Herdis Larsen, MD | |
| Principal Investigator: | Hans C Hasselbalch, MD | Copenhagen University Hospital Herlev, Department of Haematology |
More Information
| Responsible Party: | Copenhagen University Hospital at Herlev |
| ClinicalTrials.gov Identifier: | NCT00909077 History of Changes |
| Other Study ID Numbers: | ITP-Rituximab-DXM |
| Study First Received: | May 26, 2009 |
| Last Updated: | December 12, 2011 |
| Health Authority: | Denmark: Danish Medicines Agency |
|
ITP-Rituximab-dexamethasone |
|
Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia Blood Platelet Disorders Immune System Diseases Hemorrhagic Disorders Autoimmune Diseases |
Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Rituximab BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids |
