Status:
COMPLETED
Prednisone or Dexamethasone in Newly Diagnosed, Previously Untreated Primary Immune Thrombocytopenic Purpura
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Nonneoplastic Condition
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs, such as prednisone and dexamethasone, may change the immune system and be an effective treatment for primary immune thrombocytopenic purpura. It is not yet known which drug is more e...
Detailed Description
OBJECTIVES: Primary * To evaluate the role of therapy intensification in adult patients with newly diagnosed, previously untreated primary immune thrombocytopenic purpura with high-dose dexamethason...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Signed written informed consent according to IGH/EU/GCP and national local laws
- Newly diagnosed untreated ITP adult patients
- Age \> 18 \< 80 years
- Platelet count \<20x109/L
- Platelet count \> 20 x109/L and \<50x109/L plus bleeding with score \> 8 (according to grading scale at paragraph 7.1)
- Baseline Quality of Life evaluation questionnaire filled in Newly diagnosed untreated ITP adult patients
- Age \> 18 \< 80 years
- Platelet count \<20x109/L
- Platelet count \> 20 x109/L and \<50x109/L plus bleeding with score \> 8 (according to grading scale at paragraph 7.1)
- Baseline Quality of Life evaluation questionnaire filled in
- Exclusion criteria
- Active malignancy at time of study entry
- Steroids administration (PDN \<1mg/Kg/day) for more than 5 days before randomization
- Concomitant treatment with anti-platelet and or anti-coagulant drugs
- Concomitant severe psychiatric disorders
- Not confirmed diagnosis of ITP for
- \*Positivity of autoimmunity markers: antinucleus (≥1:80), anti-tireoglobulin, anti-tireoperoxidase, anti-cardiolipin (≥ 40 GPL UmL), anti-b2glycoprotein (≥ 40 IgG U/mL) antibodies, Lupus Anticoagulant (KCT ratio, dRVVT ratios ≥1.5 times the upper normal limit ), direct antiglobulin test (DAT ).
- Presence of autoimmune hemolytic anemia
- Presence of connective tissue disease
- Women who are pregnant or breastfeeding
- Cardiovascular diseases requiring treatment
- Severe non-controlled, despite therapy, hypertension and diabetes
- Liver and kidney function impairment (creatinine, ALT, AST \>2 times upper normal limit)
- HCVAb, HIVAb, HBsAg, HBcAb seropositive status
- Chronic liver disease
- Documented viral illness by the positivity of IgM, or vaccination both occurred one month before diagnosis
- Intake of drugs not previously taken within one week before diagnosis
- Bleeding score 15 due to ICH or to GI bleeding (according to grading scale at paragraph 7.1, Tab. 3)
- Active gastric ulcer.
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00657410
Start Date
April 1 2008
End Date
February 1 2016
Last Update
February 20 2017
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico
Tricase, (le), Italy
2
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
3
Azienda ospedaliera Nuovo Ospedale "Torrette"
Ancona, Italy
4
USL 8 - Ospedale S.Donato
Arezzo, Italy