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• Authorised

• TMC435-TiDP16-C208 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients
• Hepatitis C Virus (HCV) in treatment naïve patients MedDRA version: 14.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 10022891 - Investigations ;Therapeutic area: Diseases [C] - Virus Diseases [C02]
• Australia, Canada, Germany, Israel, Italy, Mexico, Netherlands, New Zealand, Romania, Russian Federation, Spain, Ukraine, United Kingdom, United States
• 2010-12-06

• Authorised

• A study to evaluate whether VX-371 is safe and makes breathing easier in patients with primary ciliary dyskinesia (study also known as CLEAN-PCD or PS-G202)
• Primary Ciliary Dyskinesia br>MedDRA version: 20.0 Level: PT Classification code 10069713 Term: Primary ciliary dyskinesia System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
• Australia, Canada, Denmark, Germany, Italy, Netherlands, Poland, United Kingdom, United States
• 2016-05-19

• Authorised

• A long-term follow-up study (ZOE-LTFU) of two studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine and assessment of 1 or 2 additional doses in two subgroups of older adults.
• Vaccination against HZ and its related complications in adults older than 50 years (at the time of primary vaccination). MedDRA version: 19.1 Level: LLT Classification code 10019982 Term: Herpes zoster NOS System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Virus Diseases [C02]
• Australia, Brazil, Canada, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Mexico, Spain, Sweden, Taiwan, United Kingdom, United States
• 2016-02-04

• Authorised

• The First-in-Human Study of an Investigational Drug, ALN-GO1, in Healthy Adult Subjects and Patients with Primary Hyperoxaluria Type 1 Disease
• Primary Hyperoxaluria Type 1 (PH1) MedDRA version: 20.1 Level: PT Classification code 10020703 Term: Hyperoxaluria System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
• France, Germany, Israel, Jordan, Netherlands, United Kingdom, United States
• 2015-12-21

• Authorised

• A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Autosomal Dominant Polycystic Kidney Disease (ADPKD), Patients with Increased Risk of Liver Injury;Therapeutic area: Not possible to specify
• Argentina, Belgium, France, Germany, Japan, United States
• 2015-12-17

• Authorised

• A Phase 1/2 Study of Azacitidine in Combination With Pembrolizumab and Epacadostat Advanced Solid Tumors including Lung and Colorectal Cancer
• Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non–Small Cell Lung Cancer and Stage IV Microsatellite Stable Colorectal Cancer MedDRA version: 20.0 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10048683 Term: Advanced cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Italy, Spain, United Kingdom, United States
• 2017-05-12

• Authorised

• A study to evaluate whether VX-371 is safe and makes breathing easier in patients with primary ciliary dyskinesia (study also known as CLEAN-PCD or PS-G202)
• Primary Ciliary Dyskinesia br>MedDRA version: 20.0 Level: PT Classification code 10069713 Term: Primary ciliary dyskinesia System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
• Canada, Denmark, Germany, Italy, Netherlands, Poland, United Kingdom, United States
• 2016-07-28

• Authorised

• A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease
• Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
• Austria, Bulgaria, Croatia, France, Georgia, Germany, Greece, Hungary, Israel, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Ukraine, United Kingdom, United States
• 2018-07-26

• Authorised

• A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease
• Crohn's Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: LLT Classification code 10011398 Term: Crohn's System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
• Australia, Brazil, Canada, Czech Republic, France, Germany, Hungary, Italy, Korea, Republic of, Mexico, Poland, Romania, Spain, Taiwan, United Kingdom, United States
• 2018-07-05

• Authorised

• A non-blinded study of multiple doses of RZ358, in patients with low blood sugars due to genetic dysfunction resulting in over-secretion of insulin
• Hypoglycemia associated with congenital hyperinsulinism MedDRA version: 20.1 Level: LLT Classification code 10077227 Term: Hyperinsulinemic hypoglycemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: LLT Classification code 10020644 Term: Hyperinsulinism NOS System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10061211 Term: Hyperinsulinism System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.1 Level: LLT Classification code 10022484 Term: Insulin hypoglycaemia System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
• Bulgaria, Croatia, Denmark, France, Germany, Israel, Netherlands, Serbia, Spain, Turkey, United Kingdom, United States
• 2016-11-08