Departament studii clinice Lista studii clinice

Studii clinice

STUDII CLINICE

CONF. UNIV. DR. GHERLAN GEORGE SEBASTIAN

  • 1. A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Phase II Study on the Efficacy and Safety of Debio 025 Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients, Debio 025-HCV-205 - 2009/2010 – Subinvestigator
  • 2. Protocol 526H04 Randomized, Controlled Phase 2a/b Study of the Efficacy and Safety of PEG-rIL-29Administered in Combination with Ribavirin to Treatment-Naïve Subjects with Chronic Hepatitis C Infection – 2010/2012 – Study Coordinator, Subinvestigator
  • 3. Studiu clinic de faza IV al imunogenicitatii si rectogenitatii vaccinului gripal trivalent, inactivat preparat pentru sezonul 2010/2011 de INCDMI – Cantacuzino – Study Coordinator, Subinvestigator
  • 4. A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment, CDEB025A2210, 2011/2013– Study Coordinator, Subinvestigator
  • 5. A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve, CDEB025A2301, 2011/2013 - Study Coordinator, Subinvestigator
  • 6. Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in Which Peginterferon Lambda-1a (BMS-914143) Was Administered for the Treatment of Chronic Hepatitis C, AI452-016, 2012/2016 – Study Coordinator, Subinvestigator
  • 7. A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 with Ritonavir (ABT-450/r) and ABT-267 in Adults with Chronic Hepatitis C Virus Infection (PEARL-I), M13-393, 2012/2014 – Study coordinator, Subinvestigator
  • 8. A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered with and without Ribavirin Compared to Telaprevir Co-administered with Pegylated Interferon α-2a and Ribavirin in Treatment-Naïve Adults with Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE I), M13 – 774, 2013/2015 – Subinvestigator
  • 9. A multi-centre 3-year follow-up study to assess the durability of sustained virologic response in Alisporivir treated chronic Hepatitis C patients, CDEB025A2312, 2013/2016 - Study coordinator, Subinvestigator
  • 10. A multi-centre 3-year follow-up study to assess the viral activity in patients who failed to achieve sustained virologic response in Novartis-sponsored Alisporivir studies for chronic Hepatitis C patients, CDEB025A2313, 2013/2016 - Study coordinator, Subinvestigator
  • 11. A phase 3, double-blind, multicentre, randomised, placebo-controlled study to determine the efficacy and safety of SPL7013 Gel (VivaGel®) to prevent the recurrence of bacterial vaginosis, SPL7013-018, 2015 – 2016 - Study coordinator, Subinvestigator
  • 12. A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1), M13 – 590, 2016, Study coordinator, Subinvestigator
  • 13. Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Romania, P 15 – 698, 2016/2017, Subinvestigator
  • 14. A Study of Oral VT-1161 for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (VIOLET) VMT-VT-1161-CL-011, 2018 – 2020. Study coordinator, Subinvestigator
  • 15. A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection who Are at Risk of Developing Complications (DIAMOND STUDY - 63623872FLZ3002), 2018 – suspended, Investigator Principal
  • 16. A Phase 3, randomized, double-blind, active controlled study to compare the efficacy and safety of ridinilazole (200 mg, bid) for 10 days with vancomycin (125 mg, qid) for 10 days in the treatment of Clostridium difficile infection (CDI), 2019 – 2021, Investigator Principal
  • 17. A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID With and Without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared With PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected With Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)Ide Therapy (D-LIVR), 2019 – 2023, Investigator Principal
  • 18. A Multicenter, Open-label, Randomized Phase 2b Clinical Study to Assess Efficacy and Safety of Bulevirtide in Combination with Pegylated Interferon alfa-2a in Patients with Chronic Hepatitis Delta, MYR 204, 2019 -2021 – Investigator Principal
  • 19. CT-P59 3.2 A Phase 2/3, Randomized, Parallel-group, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of CT-P59 in Combination with Standard of Care in Outpatients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection, 2020 – continua, Subinvestigator
  • 20. MP1032-CT05 A randomized, double-blind, placebo-controlled, multicenter, proof-of-concept, phase II A study of MP1032 plus standard of care vs standard of care in the treatment of hospitalized patients with moderate to severe COVID -19. 2021 – 2022 Investigator Principal
  • 21. EIG-LMD-002 Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV (LIMT-2) – 2022 – 2024 - Investigator Principal
  • 22. GS-US-589-6206 is a Registry Study of Treatment with Bulevirtide (BLV), Hepcludex in Participants with Chronic Hepatitis D (HDV) Infection 2023- ongoing. Principal Investigator
  • 23. 23. CF102-212LD: A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH). 2024 – ongoing. Principal Investigator
  • 24. 24. ZP8396-23094: A Randomized, Double-Blind, Phase 2, Dose-Finding Trial of Once-Weekly Petrelintide Compared with Placebo In Participants With Obesity or Overweight with Weight-Related Comorbidities 2024 – ongoing. Study coordinator/SI
  • 25. 25. A randomised, double-blind, placebo-controlled phase 3 study of VE303 for prevention of recurrent Clostridioides difficile infection: the Restorative303 study, Principal Investigator
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