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해외임상승인현황 정보 :: 순번, 임상시험 제목, 적응증, 연구설계, 의뢰자/실시기관, 임상단계, 게시일자
순번 임상시험 제목 적응증 연구설계 의뢰자/실시기관 임상단계 게시일자
1 Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS Relapsing Multiple Sclerosis Biological: Ofatumumab|Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap)|Biological: 13-valent pneumococcal conjugate vaccine (13-PCV)|Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV)|Biological: Seasonal Quadrivalent influenza vaccine|Biological: Keyhole limpet hemocyanin (KLH) neo-antigen Novartis Pharmaceuticals|Novartis Phase 3 2018-12-28
2 A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. Chronic Spontaneous Urticaria Biological: Ligelizumab|Biological: Omalizumab|Other: Placebo Novartis Pharmaceuticals|Novartis Phase 3 2018-10-20
3 A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines Chronic Spontaneous Urticaria Biological: Ligelizumab|Biological: Omalizumab|Other: Placebo Novartis Pharmaceuticals|Novartis Phase 3 2018-10-17
4 Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin짰 in HER2+ Early Breast Cancer Breast Cancer|Breast Neoplasms|HER2-positive Breast Cancer|Stage II Breast Cancer|Stage IIIA Breast Cancer Biological: TX05 (trastuzumab)|Biological: Herceptin짰|Drug: Paclitaxel|Drug: Epirubicin|Drug: Cyclophosphamide Tanvex BioPharma USA, Inc. Phase 3 2018-06-28
5 An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) Ulcerative Colitis Drug: Mirikizumab|Drug: Placebo Eli Lilly and Company Phase 3 2018-06-18
6 A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations Urothelial Cancer Drug: Erdafitinib|Drug: Vinflunine|Drug: Docetaxel|Drug: Pembrolizumab|Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) Janssen Research & Development, LLC Phase 3 2018-03-23
7 Alphanate in Immune Tolerance Induction Therapy Hemophilia A, Congenital Biological: Alphanate Grifols Therapeutics LLC Phase 2 2018-01-03
8 Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence in India Prevention of TB Recurrence Biological: VPM1002 (Recombinant BCG Vaccine)|Other: Placebo Serum Institute of India Pvt. Ltd. Phase 2|Phase 3 2017-12-15
9 Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India Rotavirus Gastroenteritis Biological: Liquid Rotavirus Vaccine Serum Institute of India Pvt. Ltd. Phase 2|Phase 3 2017-10-30
10 Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury Brain Death Biological: BQ-A Peptide Extract|Biological: Mesenchymal Stem Cells|Device: Transcranial Laser Therapy|Device: Median Nerve Stimulator Bioquark Inc.|Revita Life Sciences|Anupam Hospital Phase 1 2017-07-01