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• Authorised

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• Chronic Hepatitis C Genotype 1 patients MedDRA version: 15.0 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Virus Diseases [C02]
• Australia, Belgium, France, Germany, Hungary, Italy, Poland, Romania, Spain, Taiwan, Turkey, United Kingdom, United States
• 2010-06-21

• Authorised

• A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy
• Primary IgA Nephropathy br>MedDRA version: 20.0 Level: HLGT Classification code 10029149 Term: Nephropathies System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
• Argentina, Australia, Belgium, China, Denmark, Finland, Germany, Korea, Republic of, Netherlands, Norway, Singapore, Sweden, Taiwan, Thailand, United Kingdom, United States
• 2017-11-23

• Authorised

• A study evaluating the of safety and efficacy of LNP023 in patients with a kidney disorder called IgAN nephropathy
• Primary IgA Nephropathy br>MedDRA version: 20.0 Level: HLGT Classification code 10029149 Term: Nephropathies System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
• Argentina, Australia, Belgium, China, Denmark, Finland, Germany, Korea, Republic of, Netherlands, Norway, Singapore, Sweden, Taiwan, Thailand, United Kingdom, United States
• 2017-10-17

• Authorised

• A Trial on Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors
• Phase 1 – Part A dose escalation in patients with metastatic or locally advanced solid tumor for which no standard therapy exists or standard therapy has failed. Phase 2 - Part B unresectable or metastatic cervical cancer with disease progression after a platinum-based first-line regimen. MedDRA version: 20.0 Level: LLT Classification code 10008236 Term: Cervical cancer stage IV System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10008231 Term: Cervical cancer recurrent System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, Brazil, Hungary, Poland, Spain, Ukraine, United States
• 2018-11-23

• Authorised

• A trial of AGEN1884 with AGEN2034 in Advanced Tumors
• Phase 1 – Part A dose escalation in patients with metastatic or locally advanced solid tumor for which no standard therapy exists or standard therapy has failed. Phase 2 - Part B unresectable or metastatic cervical cancer with disease progression after a platinum-based first-line regimen. MedDRA version: 20.0 Level: LLT Classification code 10008236 Term: Cervical cancer stage IV System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10008231 Term: Cervical cancer recurrent System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, Brazil, Hungary, Poland, Spain, Ukraine, United States
• 2018-09-26

• Authorised

• This open label trial will recruit patients with HIV who are already receiving anti-HIV treatment which includes a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) and emtricitabine/tenofovir disoproxil fumurate (Truvada). Patients will be randomised to either remain on the same anti-HIV drugs as prior to the study (namely consisting of NNRtI and Truvada) or switch to receive an investigational single tablet regimen (EVG/COBI/FTC/TDF) which contains 2 experimental drugs (EVG and COBI).
• Human Immunodeficiency Virus (HIV-1) Infections MedDRA version: 14.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
• Australia, Austria, Canada, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States
• 2011-11-21

• Authorised

• A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease
• Moderately to severely active Crohn's disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
• Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, European Union, Germany, Hungary, Iceland, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Russian Federation, Serbia, South Africa, Spain, United Kingdom, United States
• 2011-05-26

• Authorised

• Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy alone for Patients With Lung Cancer (POSEIDON).
• First-line patients with metastatistic non-small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Brazil, Bulgaria, China, Germany, Hong Kong, Hungary, Japan, Korea, Republic of, Mexico, Peru, Poland, Russian Federation, South Africa, Taiwan, Thailand, Ukraine, United Kingdom, United States, Vietnam
• 2017-05-29

• Authorised

• A Phase 1/3 Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincristine, and Prednisone (CVP) in Patients With Advanced Follicular Lymphoma
• Advanced Follicular Lymphoma 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] - Cancer [C04]
• Belarus, Brazil, Bulgaria, Chile, Georgia, Greece, India, Italy, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Turkey, Ukraine
• 2014-01-22

• Authorised

• A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination with Cabozantinib vs. Placebo with Cabozantinib in Patients with Advanced or Metastatic Renal Cell Carcinoma. Randomized means allocation to CB-839 or a placebo isde termined by chance. 1 out of every 2 patients will get CB-839. Double-blinded means that neither the participant nor investigator knows what group the patient is assigned to. Every patient on study will get cabozantinib.
• Advanced or metastatic clear-cell renal cell carcinoma;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, France, Germany, Italy, New Zealand, Spain, United Kingdom, United States
• 2018-05-21