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1.  CenterWatch: New Medical Therapies in Disease Category (626), Gaucher Disease
...kg of Uplyso administered intravenously once every two weeks. The primary endpoint, mean reduction in spleen volume after nine months compared with baseline values, was reached for both arms (p<0 ...
...p<0.0001). Statistically significant improvements compared with baselines were also observed in platelet and spleen sizes. While the primary endpoint was not reached with statistical significance in the 40 U ...
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2.  CenterWatch: New Medical Therapies in Disease Category (833), Metabolic Disorders
...p<0.0001). Statistically significant improvements compared with baselines were also observed in platelet and spleen sizes. While the primary endpoint was not reached with statistical significance in the 40 U/kg dose arm, statistically significant improvements in hemoglobin, platelet count, and spleen volume were demonstrated. Velaglucerase alfa was generally well tolerated with no drug-related serious adverse ...
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3.  Newly Approved Drug Therapies (1035) Feraheme (ferumoxytol), AMAG,
...plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in ...
...plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in ...
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4.  Newly Approved Drug Therapies (534) Ferrlecit, R&D Laboratories,
...grams. Approximately 2/3 is in hemoglobin and 1/3 in reticuloendothelial storage (bone marrow, spleen, liver) and ferritin. The body highly conserves iron (daily loss of 0.03%) requiring supplementation ...
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5.  Study Posting (1819) Trial #95890, Sickle Cell Disease, Cincinnati, OH
...develop an acute sickle event (ACS, pain crises, fever, stroke, splenic sequestration [enlarged and painful spleen], hemolytic crisis or priapism [painful erection]), the measurements will be repeated during a routine visit ...
...cough/wheezing/chest pain, suspected or impending acute chest syndrome, splenic sequestration (enlarged and painful spleen), or priapism (painful erection). Testing will stop immediately if you develop ACS within the four ...
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6.  CenterWatch: New Medical Therapies in Disease Category (769), Hunter Syndrome (MPS II)
...Data demonstrated a significant reduction in urinary glycosaminglycan (GAG) excretion, significant reductions in liver and spleen volumes, as well as reductions in left ventricular mass and improvements in forced vital capacity ...
...group. I2S also demonstrated a mean reduction of mass in enlarged organs such as liver, spleen and heart. Transkaryotic Therapies believes the data from this trial support the advancement of this ...
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7.  Study Posting (77) Trial #141972, Pulmonary Arterial Hypertension, New Hyde Park, NY
...diseases such as portal hypertension (high blood pressure in the veins of the stomach, intestine, spleen, pancreas and liver), blood clot diseases, or pulmonary obstruction diseases • Have been diagnosed with uncontrolled ...
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8.  Newly Approved Drug Therapies (702) Campath, Berlex Laboratories,
...This accumulation leads to bone marrow dysfunction and enlargement of the lymph nodes, liver, and spleen. Related symptoms of the disease include fatigue, bone pain, night sweats, decreased appetite, and weight ...
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9.  News: CenterWatch Monthly December 2009 (Clinical Trials Today)
...rapidly or have a longer than normal life span, may arise in the lymph nodes, spleen or other organs, bone marrow or  blood.To read the full articles for this issue ...
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10.  Study Posting (4519) Trial #103753, Lymphomas, Visby, Sweden
...a maximum of 6 months chlorambucil or cyclophosphamide; • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or ...
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11.  Study Posting (4519) Trial #103752, Lymphomas, Vaxjo, Sweden
...a maximum of 6 months chlorambucil or cyclophosphamide; • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or ...
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12.  Study Posting (4519) Trial #112635, Lymphomas, Västerås, Sweden
...a maximum of 6 months chlorambucil or cyclophosphamide; • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or ...
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13.  Study Posting (4519) Trial #101621, Lymphomas, Uppsala, Sweden
...a maximum of 6 months chlorambucil or cyclophosphamide; • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or ...
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14.  Study Posting (4519) Trial #100129, Lymphomas, Umea, Sweden
...a maximum of 6 months chlorambucil or cyclophosphamide; • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or ...
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15.  Study Posting (4519) Trial #100992, Lymphomas, Sundsvall, Sweden
...a maximum of 6 months chlorambucil or cyclophosphamide; • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or ...
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16.  Study Posting (4519) Trial #100471, Lymphomas, Stockholm, Sweden
...a maximum of 6 months chlorambucil or cyclophosphamide; • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or ...
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17.  Study Posting (4519) Trial #101789, Lymphomas, Oerebro, Sweden
...a maximum of 6 months chlorambucil or cyclophosphamide; • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or ...
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18.  Study Posting (4519) Trial #100904, Lymphomas, Malmoe, Sweden
...a maximum of 6 months chlorambucil or cyclophosphamide; • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or ...
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19.  Study Posting (4519) Trial #101642, Lymphomas, Lund, Sweden
...a maximum of 6 months chlorambucil or cyclophosphamide; • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or ...
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20.  Study Posting (4519) Trial #103745, Lymphomas, Lulea, Sweden
...a maximum of 6 months chlorambucil or cyclophosphamide; • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or ...
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