Exclusion criteria
| Exclusion criteria |
| Active malignancy at time of study entry |
| Steroid administration for >5 d before randomization∗ |
| Concomitant treatment with antiplatelet and/or anticoagulant drugs |
| Concomitant severe psychiatric disorders |
| Unconfirmed diagnosis of primary ITP for Positivity† of autoimmunity markers: anti-nucleus (≥1:80), anti-thyroglobulin, anti-thyroperoxidase, anti-cardiolipin (≥40 GPL U/mL), anti–β2-glycoprotein (≥40 IgG U/mL) antibodies, Lupus anticoagulant (KCT ratio, dRVVT ratio ≥1.5 times the upper normal limit), direct antiglobulin test. Presence of autoimmune hemolytic anemia Presence of connective tissue disease |
| Women who are pregnant or breastfeeding |
| Cardiovascular diseases requiring treatment |
| Severe, noncontrolled despite therapy hypertension and diabetes |
| Liver and kidney function impairment (creatinine level, ALT, AST >2-times the upper normal limit) |
| HCV Ab, HIV Ab, HBsAg, HBc Ab seropositive status |
| Chronic liver disease |
| Documented viral illness by the positivity of IgM, or vaccination, both occurred 1 mo before diagnosis |
| Intake of drugs not previously taken within 1 wk before diagnosis |
| Bleeding score of 15 because of ICH or to GI bleeding (according to grading scale in Table 3) |
| Active gastric ulcer |
| Exclusion criteria |
| Active malignancy at time of study entry |
| Steroid administration for >5 d before randomization∗ |
| Concomitant treatment with antiplatelet and/or anticoagulant drugs |
| Concomitant severe psychiatric disorders |
| Unconfirmed diagnosis of primary ITP for Positivity† of autoimmunity markers: anti-nucleus (≥1:80), anti-thyroglobulin, anti-thyroperoxidase, anti-cardiolipin (≥40 GPL U/mL), anti–β2-glycoprotein (≥40 IgG U/mL) antibodies, Lupus anticoagulant (KCT ratio, dRVVT ratio ≥1.5 times the upper normal limit), direct antiglobulin test. Presence of autoimmune hemolytic anemia Presence of connective tissue disease |
| Women who are pregnant or breastfeeding |
| Cardiovascular diseases requiring treatment |
| Severe, noncontrolled despite therapy hypertension and diabetes |
| Liver and kidney function impairment (creatinine level, ALT, AST >2-times the upper normal limit) |
| HCV Ab, HIV Ab, HBsAg, HBc Ab seropositive status |
| Chronic liver disease |
| Documented viral illness by the positivity of IgM, or vaccination, both occurred 1 mo before diagnosis |
| Intake of drugs not previously taken within 1 wk before diagnosis |
| Bleeding score of 15 because of ICH or to GI bleeding (according to grading scale in Table 3) |
| Active gastric ulcer |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; dRVVT, diluted Russell viper venom time; GI, gastrointestinal; GPL, IgG phospholipid unit; HBc Ab, Hepatitis B core antibodies; HBsAg, Hepatitis B surface antigen; HCV Ab, Hepatitis C virus antibodies; HIV Ab, human immunodeficiency virus antibodies; ICH, intracranial hemorrhage; IgG, immunoglobulin G; IgM, immunoglobulin M; KCT, Kaolin clotting time.
If steroid administration lasted <5 days before randomization, only equivalent doses of PDN of <1 mg/kg per day were allowed.
The results of autoimmunity markers were mandatory for patient eligibility; however, to avoid delay in the treatment start, patients could be randomized before the results of these tests were available. If evidence of positivity, the patient was no longer eligible even if the treatment had been started.