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1. Full Text Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial
by Kuter, David J, Prof and Bussel, James B, MD and Lyons, Roger M, MD and Pullarkat, Vinod, MD and Gernsheimer, Terry B, MD and Senecal, Francis M, MD and Aledort, Louis M, MD and George, James N, MD and Kessler, Craig M, MD and Sanz, Miguel A, MD and Liebman, Howard A, MD and Slovick, Frank T, MD and de Wolf, J Th M, MD and Bourgeois, Emmanuelle, MD and Guthrie, Troy H, MD and Newland, Adrian, MA and Wasser, Jeffrey S, MD and Hamburg, Solomon I, MD and Grande, Carlos, MD and Lefrère, François, MD and Lichtin, Alan Eli, MD and Tarantino, Michael D, MD and Terebelo, Howard R, DO and Viallard, Jean-François, MD and Cuevas, Francis J, MD and Go, Ronald S, MD and Henry, David H, MD and Redner, Robert L, MD and Rice, Lawrence, MD and Schipperus, Martin R, MD and Guo, D Matthew, PhD and Nichol, Janet L, MS
Lancet, The, ISSN 0140-6736, 02/2008, Volume 371, Issue 9610, pp. 395 - 403
Summary Background Chronic immune thrombocytopenic purpura (ITP) is characterised by accelerated platelet destruction and decreased platelet production.... 
Internal Medicine | AUTOANTIBODIES | ADULT PATIENTS | IN-VITRO | AMG-531 | MEGAKARYOCYTES | CHRONIC ITP | PLATELET DESTRUCTION | SPLENECTOMY | UMCG Approved | THROMBOPOIETIN LEVELS | TGF-BETA-1 | MEDICINE, GENERAL & INTERNAL | Double-Blind Method | Drug Administration Schedule | Humans | Middle Aged | Male | Treatment Outcome | Recombinant Fusion Proteins | Thrombopoietin | Receptors, Fc - therapeutic use | Carrier Proteins - adverse effects | Splenectomy | Platelet Count | Receptors, Fc - administration & dosage | Carrier Proteins - administration & dosage | Purpura, Thrombotic Thrombocytopenic - drug therapy | Purpura, Thrombotic Thrombocytopenic - immunology | Adult | Female | Aged | Carrier Proteins - therapeutic use | Purpura, Thrombotic Thrombocytopenic - blood | Chronic Disease - drug therapy | Thrombocytopenic purpura | Drug therapy | Research | Clinical trials | Blood diseases | Medical treatment | Chronic illnesses
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2. Full Text Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP
by Bussel, James B and Kuter, David J and Pullarkat, Vinod and Lyons, Roger M and Guo, Matthew and Nichol, Janet L
Blood, ISSN 0006-4971, 03/2009, Volume 113, Issue 10, pp. 2161 - 2171
Chronic immune thrombocytopenic purpura (ITP) is characterized by low platelet counts and mucocutaneous bleeding. In previous studies romiplostim (AMG531), a... 
AUTOIMMUNE THROMBOCYTOPENIA | ADULT PATIENTS | INTRAVENOUS GAMMA-GLOBULIN | IN-VITRO | PURPURA | AMG-531 | BONE-MARROW | SPLENECTOMY | PLATELET PRODUCTION | HEMATOLOGY | THROMBOPOIETIN LEVELS | Humans | Middle Aged | Male | Recombinant Fusion Proteins | Thrombopoietin | Purpura, Thrombocytopenic, Idiopathic - drug therapy | Carrier Proteins - adverse effects | Platelet Count | Receptors, Fc - administration & dosage | Carrier Proteins - administration & dosage | Female | Blood Platelets - drug effects | Thrombopoiesis - drug effects
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3. Full Text Pathogenesis of chronic immune thrombocytopenia: increased platelet destruction and/or decreased platelet production
by Nugent, Diane and McMillan, Robert and Nichol, Janet L and Slichter, Sherrill J
British Journal of Haematology, ISSN 0007-1048, 09/2009, Volume 146, Issue 6, pp. 585 - 596
Summary Chronic immune thrombocytopenia (ITP) is a haematological disorder in which patients predominantly develop skin and mucosal bleeding. Early studies... 
platelet survival | thrombopoietin | platelet destruction | platelet production | immune thrombocytopenia | Platelet production | Immune thrombocytopenia | Platelet survival | Platelet destruction | Thrombopoietin | PURPURA ITP | BONE-MARROW MEGAKARYOCYTES | RETICULATED PLATELETS | AUTOIMMUNE THROMBOCYTOPENIA | SERUM THROMBOPOIETIN LEVELS | IN-VITRO | CIRCULATING THROMBOPOIETIN | ANTIPLATELET ANTIBODIES | HEMATOLOGY | APLASTIC-ANEMIA | T-CELLS | Blood Platelets - pathology | Thrombopoietin - metabolism | Blood Platelets - immunology | Platelet Count | Autoantibodies - blood | Humans | Thrombocytopenia - immunology | Thrombopoiesis - immunology | Thrombocytopenia - pathology | Chronic Disease | Thrombocytopenia | Growth factors | Immunoglobulin G
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4. Full Text AMG 531, a Thrombopoiesis-Stimulating Protein, for Chronic ITP
by Bussel, James B and Kuter, David J and George, James N and McMillan, Robert and Aledort, Louis M and Conklin, George T and Lichtin, Alan E and Lyons, Roger M and Nieva, Jorge and Wasser, Jeffrey S and Wiznitzer, Israel and Kelly, Reggie and Chen, Chien-Feng and Nichol, Janet L
The New England Journal of Medicine, ISSN 0028-4793, 10/2006, Volume 355, Issue 16, pp. 1672 - 1681
AMG 531 is a novel dipeptide linked to the Fc fragment of IgG. It is structurally unrelated to thrombopoietin but can stimulate the thrombopoietin receptor. In... 
IDIOPATHIC THROMBOCYTOPENIC PURPURA | ANTIBODIES | AUTOANTIBODIES | MEDICINE, GENERAL & INTERNAL | IN-VITRO | DESTRUCTION | PLATELET PRODUCTION | MEGAKARYOCYTE GROWTH | APLASTIC-ANEMIA | CHEMOTHERAPY | MEGAKARYOPOIESIS | Humans | Middle Aged | Male | Adrenal Cortex Hormones - therapeutic use | Thrombopoietin - blood | Recombinant Fusion Proteins | Purpura, Thrombocytopenic, Idiopathic - blood | Purpura, Thrombocytopenic, Idiopathic - drug therapy | Carrier Proteins - adverse effects | Dose-Response Relationship, Drug | Thrombopoietin - immunology | Platelet Count | Receptors, Fc - immunology | Receptors, Fc - administration & dosage | Injections, Subcutaneous | Carrier Proteins - administration & dosage | Adult | Antibodies - blood | Female | Aged | Thrombopoiesis - drug effects | Carrier Proteins - immunology | Thrombocytopenic purpura | Care and treatment | Health aspects | Risk factors | Clinical trials | Medical research
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5. Full Text Pharmacodynamics and pharmacokinetics of AMG 531, a novel thrombopoietin receptor ligand
by Wang, Bing and Nichol, Janet L and Sullivan, John T
Clinical Pharmacology & Therapeutics, ISSN 0009-9236, 12/2004, Volume 76, Issue 6, pp. 628 - 638
Objective The objective of this study was to evaluate the tolerability, pharmacodynamics, and pharmacokinetics of AMG 531, a novel thrombopoietin receptor... 
MPL-LIGAND | ANTIBODIES | IN-VITRO | STIMULATION | BIOLOGY | PURIFICATION | RECOMBINANT HUMAN THROMBOPOIETIN | THROMBOCYTOPENIA | PHARMACOLOGY & PHARMACY | PLATELET PRODUCTION | MEGAKARYOCYTE GROWTH | Injections, Intravenous | Humans | Male | Neoplasm Proteins - metabolism | Recombinant Fusion Proteins | Thrombopoietin | Neoplasm Proteins - drug effects | Carrier Proteins - adverse effects | Dose-Response Relationship, Drug | Carrier Proteins - pharmacology | Injections, Subcutaneous | Platelet Aggregation Inhibitors - pharmacology | Adult | Female | Platelet Aggregation Inhibitors - pharmacokinetics | Receptors, Cytokine - metabolism | Platelet Aggregation Inhibitors - adverse effects | Receptors, Fc | Proto-Oncogene Proteins - metabolism | Proto-Oncogene Proteins - drug effects | Double-Blind Method | Enzyme-Linked Immunosorbent Assay | Receptors, Thrombopoietin | Biosensing Techniques | Ligands | Carrier Proteins - pharmacokinetics | Cohort Studies | Receptors, Cytokine - drug effects
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6. Full Text Pathogenesis of chronic immune thrombocytopenia: increased platelet destruction andor decreased platelet production
by Nugent, Diane and McMillan, Robert and Nichol, Janet L and Slichter, Sherrill J
British Journal of Haematology, ISSN 0007-1048, 09/2009, Volume 146, Issue 6, pp. 585 - 596
Summary Chronic immune thrombocytopenia (ITP) is a haematological disorder in which patients predominantly develop skin and mucosal bleeding. Early studies... 
platelet survival | thrombopoietin | platelet production | immune thrombocytopenia | platelet destruction
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7. Full Text The authors reply [7]
by Bussel, James B and Kuter, David J and Nichol, Janet L
New England Journal of Medicine, ISSN 0028-4793, 01/2007, Volume 356, Issue 3, p. 308
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8. Full Text AMG 531: An investigational thrombopoiesis‐stimulating peptibody
by Nichol, Janet L
Pediatric Blood & Cancer, ISSN 1545-5009, 10/2006, Volume 47, Issue S5, pp. 723 - 725
Thrombopoietin (TPO) regulates megakaryopoiesis and the generation of platelets. Recombinant TPO has been investigated in clinical studies for use in... 
thrombopoietin | megakaryopoiesis | thrombocytopenia | platelets | Thrombocytopenia | Platelets | Megakaryopoiesis | Thrombopoietin | ANTIBODIES | RECEPTOR | PLATELET PRODUCTION | MEGAKARYOCYTE GROWTH | IN-VITRO | ONCOLOGY | PURIFICATION | PEDIATRICS | LIGAND | HEMATOLOGY | Humans | Thrombopoiesis - immunology | Recombinant Fusion Proteins | Purpura, Thrombocytopenic, Idiopathic - drug therapy | Randomized Controlled Trials as Topic | Receptors, Fc - therapeutic use | Dose-Response Relationship, Drug | Animals | Platelet Count | Receptors, Fc - immunology | Purpura, Thrombocytopenic, Idiopathic - immunology | Receptors, Fc - administration & dosage | Carrier Proteins - administration & dosage | Placebos | Carrier Proteins - therapeutic use | Thrombopoiesis - drug effects | Carrier Proteins - immunology | Clinical Trials, Phase I as Topic | Clinical Trials, Phase II as Topic
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9. Full Text AMG 531 for Chronic ITP
by Tauro, Sudhir
The New England Journal of Medicine, ISSN 0028-4793, 01/2007, Volume 356, Issue 3, pp. 307 - 308
To the Editor: Bussel et al. (Oct. 19 issue) 1 justify the rationale for using the thrombopoiesis-stimulating drug AMG 531 in chronic immune thrombocytopenic... 
THROMBOPOIESIS | MEDICINE, GENERAL & INTERNAL | Hematinics - therapeutic use | Humans | Carrier Proteins - therapeutic use | Chronic Disease | Recombinant Fusion Proteins | Thrombopoietin | Purpura, Thrombocytopenic, Idiopathic - drug therapy | Receptors, Fc - therapeutic use
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10. Full Text An open-label, unit dose-finding study of AMG 531, a novel thrombopoiesis-stimulating peptibody, in patients with immune thrombocytopenic purpura
by Newland, Adrian and Caulier, Marie T and Kappers-Klunne, Mies and Schipperus, Martin R and Lefrere, Francois and Zwaginga, Jaap J and Christal, Jenny and Chen, Chien-Feng and Nichol, Janet L
British Journal of Haematology, ISSN 0007-1048, 11/2006, Volume 135, Issue 4, pp. 547 - 553
The objective of this open label, phase 1-2, multicentre trial was to evaluate the safety of AMG 531, a novel thrombopoiesis-stimulating peptibody, and its... 
AMG 531 | thrombopoietin | immune thrombocytopenia | Thrombopoietin | Immune thrombocytopenia | ANTIBODIES | MANAGEMENT | TURNOVER | ADULTS | MEGAKARYOCYTE GROWTH | MPL-LIGAND | IN-VITRO | DESTRUCTION | PLATELETS | KINETICS | HEMATOLOGY | Drug Administration Schedule | Humans | Middle Aged | Male | Treatment Outcome | Recombinant Fusion Proteins | Patient Selection | Purpura, Thrombocytopenic, Idiopathic - blood | Purpura, Thrombocytopenic, Idiopathic - drug therapy | Receptors, Fc - therapeutic use | Carrier Proteins - adverse effects | Dose-Response Relationship, Drug | Platelet Count | Receptors, Fc - administration & dosage | Carrier Proteins - administration & dosage | Aged, 80 and over | Adult | Female | Aged | Carrier Proteins - therapeutic use | Thrombopoiesis - drug effects | Medicine, Experimental | Medical research
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11. Full Text AMG 531 for Chronic ITP/THE AUTHORS REPLY
by Sudhir Tauro and Keshava Prasad and James B Bussel and David J Kuter and Janet L Nichol
The New England Journal of Medicine, ISSN 0028-4793, 01/2007, Volume 356, Issue 3, p. 307
  In addition, the recruitment of ineligible patients (one patient received rituximab 4 weeks before enrollment, thereby violating entry criteria), differences... 
Breast cancer | Drug therapy
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12. Full Text Self‐reported health‐related quality of life in adults with chronic immune thrombocytopenic purpura
by McMillan, Robert and Bussel, James B and George, James N and Lalla, Deepa and Nichol, Janet L
American Journal of Hematology, ISSN 0361-8609, 02/2008, Volume 83, Issue 2, pp. 150 - 154
Adult chronic immune thrombocytopenic purpura (ITP) is a disorder manifested by varying degrees of purpura and mucosal bleeding, rarely including intracranial... 
SPLENECTOMY | RELIABILITY | MANAGEMENT | ITP | HEMATOLOGY | CHILDREN | Attitude to Health | Humans | Middle Aged | Male | Mental Health | Emotions | Social Behavior | Adolescent | Aged, 80 and over | Quality of Life | Adult | Female | Aged | Health Status | Purpura, Thrombocytopenic, Idiopathic - psychology | Purpura, Thrombocytopenic, Idiopathic - physiopathology
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13. Full Text Health-Related Quality of Life (HRQoL) in Patients (Pts) with Chronic Immune Thrombocytopenic Purpura (ITP): Results from Two Placebo-Controlled Phase 3 Studies of AMG 531
by George, James N and Lyons, Roger and Cuevas, Francis J and Go, Ronald S and Henry, David H and Redner, Robert L and Rice, Lawrence and Schipperus, Martin R and Mathias, Susan D and Gao, Sue and Guo, Matthew and Nichol, Janet L
Blood, ISSN 0006-4971, 11/2007, Volume 110, Issue 11, pp. 1314 - 1314
Abstract Pt-reported outcomes (PROs) are important tools for understanding the effects of treatment for various diseases. We developed the ITP Pt Assessment... 
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14. Full Text Analysis of Health-Related Quality of Life in Patients Receiving AMG 531 Using the Disease-Specific Immune Thrombocytopenic Purpura Patient Assessment Questionnaire
by George, James N and Bussel, James B and McMillan, Robert and Guo, Matthew and Okano, Gary J and Nichol, Janet L
Blood, ISSN 0006-4971, 11/2006, Volume 108, Issue 11, pp. 3292 - 3292
Abstract AMG 531 is a novel thrombopoeisis-stimulating peptibody that increases platelet production by targeting the thrombopoietin receptor. The trial... 
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15. Full Text Health-Related Quality of Life (HRQoL) in Patients with Chronic Immune Thrombocytopenic Purpura (ITP): Interim Results from an Open-Label Study of AMG 531
by Tarantino, Michael D and Henry, David H and Go, Ronald S and Lefrere, Francois and Lichtin, Alan E and Terebelo, Howard R and Viallard, Jean-Francois and Mathias, Susan D and Deeter, Robert and Nie, Kun and Nichol, Janet L
Blood, ISSN 0006-4971, 11/2007, Volume 110, Issue 11, pp. 1324 - 1324
Abstract The ITP Patient Assessment Questionnaire (ITP-PAQ) was developed to complement clinical data by assessing multiple facets of disease-specific HRQoL in... 
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16. Full Text Impact of chronic Immune Thrombocytopenic Purpura (ITP) on health-related quality of life: A conceptual model starting with the patient perspective
by Mathias, Susan D and Gao, Sue K and Miller, Kimberly L and Cella, David and Snyder, Claire and Turner, Ralph and Wu, Albert and Bussel, James B and George, James N and McMillan, Robert and Wysocki, Diane Kholos and Nichol, Janet L
Health and Quality of Life Outcomes, ISSN 1477-7525, 02/2008, Volume 6, Issue 1, pp. 13 - 13
Background: Immune thrombocytopenic purpura (ITP), a condition characterized by autoimmune-mediated platelet destruction and suboptimal platelet production, is... 
ADULT PATIENTS | COST | MANAGEMENT | ANTI-D | INTRAVENOUS IMMUNOGLOBULIN | LONG-TERM OUTCOMES | HEALTH CARE SCIENCES & SERVICES | HEALTH POLICY & SERVICES | EXPERIENCE | DISEASE-SPECIFIC MEASURE | LAPAROSCOPIC SPLENECTOMY | PREGNANCY | Models, Theoretical | Reproducibility of Results | Humans | Oklahoma | Focus Groups | Male | Purpura, Thrombocytopenic - psychology | California | New York City | Social Behavior | Adolescent | Hospitals, Teaching | Psychometrics - methods | Quality of Life | Adult | Female | Surveys and Questionnaires | Immune System Diseases - psychology | Health Status | Chronic Disease | Purpura, Thrombocytopenic - physiopathology | Thrombocytopenic purpura | Care and treatment | Research | Health aspects | Patient outcomes | Quality of life
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17. Full Text Prospective screening of 205 patients with ITP, including diagnosis, serological markers, and the relationship between platelet counts, endogenous thrombopoietin, and circulating antithrombopoietin antibodies
by Aledort, Louis M and Hayward, Catherine P.M and Chen, Mon‐Gy and Nichol, Janet L and Bussel, James and The ITP Study Grp and ITP Study Group and for the ITP Study Group
American Journal of Hematology, ISSN 0361-8609, 07/2004, Volume 76, Issue 3, pp. 205 - 213
Immune thrombocytopenia purpura (ITP) is characterized by destruction of circulating platelets and the presence of antiplatelet antibodies. Many of the current... 
antibody formation | therapeutics | megakaryocytes | thrombosis | thrombocytopenia | Thrombocytopenia | Megakaryocytes | Thrombosis | Antibody formation | Therapeutics | SYSTEMIC-LUPUS-ERYTHEMATOSUS | STIMULATION | megalkaryocytes | LEVEL | C-MPL LIGAND | MEGAKARYOCYTE GROWTH | IDIOPATHIC THROMBOCYTOPENIC PURPURA | MEDICAL PROGRESS | PURIFICATION | HEMATOLOGY | APLASTIC-ANEMIA | Purpura, Thrombocytopenic, Idiopathic - complications | Thrombosis - complications | Autoantibodies - blood | Humans | Middle Aged | Male | Thrombosis - epidemiology | Thrombopoietin - blood | Pregnancy | Purpura, Thrombocytopenic, Idiopathic - therapy | Abortion, Spontaneous - epidemiology | Thrombopoietin - immunology | Platelet Count | Purpura, Thrombocytopenic, Idiopathic - diagnosis | Antibodies, Antinuclear - blood | Adolescent | Aged, 80 and over | Adult | Female | Aged | Child | Coombs Test
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