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• Authorised

• A study of fitusiran (ALN-AT3SC) in hemophilia A and B patients without inhibitors
• Hemophilia A or Hemophilia B MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Australia, Brazil, Bulgaria, Canada, China, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Portugal, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
• 2017-07-14

• Authorised

• A Study of fitusiran (ALN-AT3SC) in hemophilia A and B patients with inhibitors
• Hemophilia A or Hemophilia B MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Australia, Bulgaria, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Portugal, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
• 2017-07-06

• Authorised

• Research study to look at how well the drug concizumab works in your body if you have haemophilia with inhibitors
• Haemophilia A with inhibitors Haemophilia B with inhibitors MedDRA version: 20.0 Level: LLT Classification code 10053751 Term: Hemophilia A with anti factor VIII System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053752 Term: Hemophilia B with anti factor IX System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
• Algeria, Australia, Austria, Bulgaria, Canada, Denmark, European Union, France, India, Japan, Korea, Republic of, Malaysia, Mexico, Norway, Poland, Portugal, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
• 2019-07-08

• Authorised

• T CELL DEPLETED HEMATOPOIETIC STEM CELL TRANSPLANT POST REDUCED INTENSITY CONDITIONING AND EARLY USE OF CYCLOPHOPHAMIDE
• -CLL patients with refractoriness to fludarabine or other chemotherapy due , Follicular lymphoma with either unfavourable cytogenetics such as complex karyotype, del17p, mutations in TP53, minus 1p- Hodgkin's Lymphoma relapsed after autologous transplantation, not elegible for immunotherapy with anti-CD30,-Multiple myeloma relapsing after autologous transplantation, with unfavourable cytogenetics in either partial or complete remission MedDRA version: 17.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.0 Level: LLT Classification code 10028567 Term: Myeloma, malignant System Organ Class: 100000004864 MedDRA version: 17.0 Level: LLT Classification code 10024341 Term: Leukemia lymphoid System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Italy
• 2013-09-19

• Authorised

• A MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF SUBCUTANEOUS OR INTRAVENOUS PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA
• Severe hemophilia A or B, with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). MedDRA version: 20.1 Level: LLT Classification code 10053754 Term: Hemophilia B without inhibitors System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053751 Term: Hemophilia A with anti factor VIII System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053753 Term: Hemophilia A without inhibitors System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053752 Term: Hemophilia B with anti factor IX System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Brazil, Bulgaria, Chile, Croatia, France, Poland, South Africa, Spain, Switzerland, United States
• 2016-10-18

• Authorised

• Chemotherapy-free combination of PCI-32765 (Ibrutinib) with Obinutuzumab (GA 101) in Patients with Previously Untreated Follicular Lymphoma (FL) and High Tumor Burden
• Stage II - IV follicular lymphoma grade 1 - 3a and a high tumor burden not previously treated MedDRA version: 20.0 Level: PT Classification code 10016908 Term: Follicle centre lymphoma, follicular grade I, II, III stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10016910 Term: Follicle centre lymphoma, follicular grade I, II, III stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10016909 Term: Follicle centre lymphoma, follicular grade I, II, III stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Germany
• 2015-09-17

• Authorised

• A Study to test the combination of two new drugs for nine rare cancer types.
• Mutations of BRAF V600E have been identified at a high frequency in melanoma, PTC, colorectal and ovarian cancers. Such mutations have also been reported in some rare cancers such as anaplastic thyroid cancer, hairy cell leukemia, gastrointestinal stromal tumors, non-seminomatous/non-geminomatous germ cell tumors, biliary tract cancer, multiple myeloma, adenocarcinoma of the small intestine, World Health Organization Grade 1 and 2 gliomas and WHO Grade 3 and 4 gliomas. MedDRA version: 16.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Austria, Belgium, Canada, Denmark, France, Germany, Italy, Korea, Democratic People's Republic of, Netherlands, Norway, Sweden, United States
• 2014-02-03

• Authorised

• Study of efficacy of consolidation immunotherapy with rituximab at high dose in patients with chronic lymphocytic leukemia who do not achieve complete eradication of their disease after standard treatment
• Patients with B-cell CLL who (1) fail to achieve eradication of minimal residual disease (MRD) after standard treatment (immunochemotherapy) of their disease, (2) who have recurrence of MRD at any time after standard immunochemotherapy MedDRA version: 17.1 Level: LLT Classification code 10068919 Term: B-cell chronic lymphocytic leukemia System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Belgium
• 2012-02-21

• Authorised

• A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS OR INTRAVENOUS PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA
• Hemophilia A or B MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10060612 Term: Hemophilia A System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Brazil, Bulgaria, Chile, Croatia, France, Malaysia, Poland, South Africa, Spain, Switzerland, United States
• 2017-11-09

• Authorised

• A Substudy to Explore Biomarkers of Physical Function in the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated with Vitamin D and Calcium - Sarcopenia Sub-Study
• This is an exploratory sub-study of Protocol 018 (Eudract N°2007-002693-66) to identify biomarkers of physical function. This biomarker sub-study will use an ongoing clinical study (Protocol 018) for osteoporosis as a starting point for identification of molecular biomarkers in circulating blood for patient identification and sarcopenia progression. Patients recruited in Protocol 018 are women 65 years of age or older with osteoporosis and either 0 or 1 prior vertebral fracture. MedDRA version: 9.1 Level: LLT Classification code 10031283 Term: Osteoporosis fracture MedDRA version: 9.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
• France
• 2009-03-19

• Authorised

• Chloroquine as an anti-autophagy drug in small cell lung cancer (SCLC) patients: A phase I trial to be followed by a phase II trial. - chloroquine in SCLC
• To determine the toxicity of adding chloroquine in escalating doses in SCLC patients - to standard dose cisplatin-etoposide in extensive disease SCLC = STEP 1 - to standard dose concurrent radiotherapy and cisplatin-etoposide in limited disease SCLC = STEP2 MedDRA version: 12.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage MedDRA version: 12.0 Level: PT Classification code 10041069 Term: Small cell lung cancer limited stage
• Netherlands
• 2010-04-28

• Authorised

• A Study of the Effect of Tazemetostat (study drug) in Patients with Relapsed or Refractory Mesothelioma
• Part 1 – Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status Part 2 – Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma MedDRA version: 20.0 Level: HLT Classification code 10027414 Term: Mesotheliomas malignant and unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10027407 Term: Mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10027406 Term: Mesothelioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10027408 Term: Mesothelioma malignant advanced System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10062474 Term: Mesothelioma malignant localized System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10027411 Term: Mesothelioma malignant recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: HLGT Classification code 10027412 Term: Mesotheliomas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• France, United Kingdom, United States
• 2017-03-22

• Authorised

• A Phase II, Single-Arm Trial of Naked Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients with Waldenström's Macroglobulinemia - hLL2-18
• Waldenström's Macroglobulinemia (WM) is an uncommon B-cell lymphoproliferative disorder that predominantly involves older patients with a slight male preponderance. WM resembles myeloma and chronic lymphocytic leukemia, but has been described as a low-grade lymphoplasmacytic lymphoma characterized by its over production of monoclonal immunoglobulin M (IgM).
• Spain
• 2005-05-23

• Authorised

• Effects and health economic aspects of enzyme therapy in children and adults with Pompe disease Long-term follow-up of patients receiving commercially available Myozyme - not applicable
• Pompe disease (glycogen storage disease type II) is a genetic, lysosomal storage disorder with a frequency of 1 in 40.000 newborns. The disease is caused by deficiency of alpha-glucosidase, a lysosomal hydrolase involved in the degradation of glycogen.
• Netherlands
• 2007-05-24

• Authorised

• The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity
• Osteoporosis and Reduced Bone mineral density (T scoresstress test) with reduced BMD (T scores< -1.0 on DEXA scan)
• United Kingdom
• 2005-12-12

• Authorised

• A Study of the Effect of Tazemetostat (study drug) in Patients with Relapsed or Refractory Mesothelioma
• Part 1 – Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status Part 2 – Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma MedDRA version: 19.1 Level: HLT Classification code 10027414 Term: Mesotheliomas malignant and unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10027407 Term: Mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10027406 Term: Mesothelioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: LLT Classification code 10027408 Term: Mesothelioma malignant advanced System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: LLT Classification code 10062474 Term: Mesothelioma malignant localized System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10027411 Term: Mesothelioma malignant recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: HLGT Classification code 10027412 Term: Mesotheliomas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• France, United Kingdom, United States
• 2016-06-28

• Authorised

• The study being done to see if the Study Drug is safe, tolerable, and can help control seizure in children with epilepsy who are aged 4 to less than 12 years of age and who are already taking seizure medications. The study will also look at pharmacokinetics, which is used to find out the concentration of perampanel in your child’s blood over a period of time.
• Epilepsy : 1) Partial-Onset Seizures (POS) 2) Primary Generalized Tonic-Clonic Seizures (PGTC) MedDRA version: 19.0 Level: HLT Classification code 10018101 Term: Generalised tonic-clonic seizures System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0 Level: PT Classification code 10061334 Term: Partial seizures System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
• Australia, Austria, Belgium, Canada, France, Hungary, Italy, Japan, Korea, Republic of, Latvia, Poland, Spain, United States
• 2016-12-12

• Authorised

• An international study to evaluate the effectiveness of Talazoparib in men with a genomic defect and metastatic castration-resistant prostate cancer who received previous chemotherapy and progressed on hormonal treatment
• Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Who Previously Received Taxane-Based Chemotherapy and Progressed on at Least 1 Novel Hormonal Agent (Enzalutamide and/or Abiraterone Acetate/Prednisone) MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Spain, United Kingdom, United States
• 2016-09-15

• Authorised

• Multiple escalating dose study of BAY 1093884 in adults with hemophilia A or B with or without inhibitors
• Hemophilia A or B MedDRA version: 20.0 Level: LLT Classification code 10053751 Term: Hemophilia A with anti factor VIII System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053753 Term: Hemophilia A without inhibitors System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053752 Term: Hemophilia B with anti factor IX System Organ Class: 100000004850 MedDRA version: 20.1 Level: LLT Classification code 10053754 Term: Hemophilia B without inhibitors System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Australia, Austria, Bulgaria, France, Hungary, Italy, Japan, Korea, Republic of, New Zealand, South Africa, Taiwan, United Kingdom
• 2018-04-12

• Authorised

• A study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of the protein tau
• Neurodegenerative disorders with Tau-pathology; including Alzheimer's disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration and important differential diagnostic conditions. MedDRA version: 17.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: PT Classification code 10053643 Term: Neurodegenerative disorder System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: LLT Classification code 10009846 Term: Cognitive impairment System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: LLT Classification code 10012285 Term: Dementia due to Pick's disease System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: PT Classification code 10012267 Term: Dementia System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: PT Classification code 10067889 Term: Dementia with Lewy bodies System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: PT Classification code 10036813 Term: Progressive supranuclear palsy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
• Sweden
• 2014-08-05