Departament studii clinice Lista studii clinice FVB

Lista studii clinice FVB

  • 1. Dose finding study in patients with mild to moderate persistent asthma: a parallel group, randomised, placebo controlled, double blind assessment of oral oc000459 dosed at three dose schedules for twelve weeks – 2009
  • 2. A multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 2 study on the efficacy and safety of Debio 025 combined with peg-interferon α2a and ribavirin in treatment-naive chronic hepatitis C genotype 1 patients 2009 - 2010
  • 3. A 26-week treatment, randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety and tolerability of nva237 in patients with chronic obstructive pulmonary disease 2010
  • 4. A phase III multicenter, 52-week treatment, randomised, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 mcg o.d. vs inhaled tiotropium 18 mcg o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD 2009 – 2012
  • 5. Randomized, controlled phase 2a/b study of the efficacy and safety of peg-rIL-29 administered in combination with ribavirin to treatment-naive subjects with chronic hepatitis C virus infection 2010 - 2011
  • 6. A phase III randomised, double-blind,placebo-controlled, parallel-group trial to evaluate efficacy and sfety 0f tiotropium inhalation solution delivered via respimat inhaler (2.5 and 5 mcg once daily)compared with salmeterol hfa mdi(50 mcg twice daily) over 24 weeks in moderate persistent asthma - 2011
  • 7. A multicentre, randomised, double-blind, placebo-controlled, parallel-group phase II study on the efficacy and safety of DEB025 combined with peg -ifn alfa -2a and ribavirin in chronic hepatitis C genotype 1 patients who are peg-ifn alfa-2 plus ribavirin treatment-experienced - 2011
  • 8. Studiul imunogenitatii si reactogenitatii vaccinului gripal trivalent, purificat, inactivat pentru administrare parenterala la adulti,preparat pentru sezonul 2010-2011- produs de INCDMI Cantacuzino 2010 - 2011
  • 9. A randomised, double -blind, placebo-controlled trial of the efficacy and safety of deb025/alisporivir in combination with standard of care in hepatitis C genotype 1 treatment-naive patients, 2011 - 2013
  • 10. Eficacitatea si siguranta combinatiilor in doza fixa de bromura de aclidinium/formoterol fumarat in comparatie cu componentele individuale si placebo atunci cand se administreaza pacientilor cu boala pulmonara obtructiva cronica stabila – 2012
  • 11. An open-label study to evaluate the safety, antiviral activity and pharmacokinetics of direct-acting antiviral agent (DAA) treatment in combination with peginterferon alfa-2a and ribavirin(pegifn/rbv) in chronic hepatitis C virus (HCV) infected subjects who have experienced virologic failure in a previous Abbott DAA combination study - 2012
  • 12. Un studiu multicentric randomizat, controlat cu placebo, cu doze diferite comparative, privind QAW039 (1-450 mg pe cale orala), pentru a cerceta efectul asupra fev1 si acq la pacientii ce sufera de astm alergic,persistent, in stadiu moderat pana la server si controlat necorespunzator prin terapie cu corticosteriozi inhalatori - 2012
  • 13. 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
  • 14. 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
  • 15. 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
  • 16. 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
  • 17. 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
  • 18. Un studiu multicentric randomizat, in regim dublu orb, cu o durata de 52 de saptamani, pentru evaluarea sigurantei medicamentului QVA149 comparativ cu QAB149 la pacientii care sufera de bronhopneumopatie obstructiva cronica (BPOC), caracterizata prin limitarea fluxului de aer, de la moderata pana la severa 2013- 2014
  • 19. Phase III: a randomised, double- blind, multi-centre study to evaluate the efficacy and safety of intravenous to oral solithromycin (cem-101) compared to intravenous to oral moxifloxacin in the treatment of adult patients with community-acquired bacterial pneumonia - 2014
  • 20. A phase 3, multicenter, randomised, double-blind, vehicle-controlled study to evaluate the safety and the efficacy of cortexolone 17 alfa-propionate (cb-03-01) 1% cream applied daily for 12 weeks in subjects with facial acne vulgaris, 2016-2017
  • 21. Un studiu de faza III, dublu-orb, multicentric, randomizat, controlat cu placebo, pentru determinarea eficacitatii si sigurantei gelului spl7013 (Vivagel) in prevenirea recurentei vaginozei bacteriene 2016
  • 22. 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
  • 23. 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
  • 24. Un studiu de faza 3,randomizat,dublu-orb,cu dublu placebo pentru compararea eficacitatii si sigurantei formulei orale de lefamulin (bc-3781)in comparatie cu formula orala de moxifloxacin in cazul adultilor cu pneumonie bacteriana dobandita in comunitate - 2016
  • 25. Studiu de faza 3 , multicentric, randomizat, dublu-orb, controlat cu medicament comparator, pentru a evalua siguranta si eficacitatea medicamentului delafloxacin pe cale intravenoasa si pe cale orala la pacienti adulti cu pneumonie bacteriana dobandita in comunitate - 2017
  • 26. Studiu multicentric, randomizat, cu durata de 52 de saptamani, in regim dublu-orb, pe grupe paralele, controlat activ pentru compararea eficatitatii si a sigurantei medicamentului QVM149 cu cele ale medicamentului QMF 149 la pacientii cu astm - 2016-2018
  • 27. Un studiu de faza 2b, randomizat, in regim dublu-orb, controlat cu placebo, de stabilire a dozei pentru evaluarea efectului RPL554 la pacienti cu BPOC moderata pana la severa - 2017-2018
  • 28. Studiu multicentric, partial orb, randomizat, cu durata de 24 de saptamani, cu grupe paralele, de non-inferioritate, deschis, controlat activ, pentru a compara eficacitatea si siguranta QVM149 cu o combinatie tripla libera de salmeterol/fluticazona + tiotropium, la pacientii cu astm necontrolat – 2017-2019
  • 29. Un studiu clinic de faza iii, randomizat, dublu-orb, controlat cu un comparator activ, pentru studierea sigurantei, tolerabilitatii si eficacitatii imipenem/cilastatin/relebactam (MK-7655a) versus piperacillin/tazobactam la subiectii cu pneumonie bacteriana dobandita in spital sau pneumonie bacteriana asociata ventilatiei mecanice – 2018-2019
  • 30. 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.
  • 31. 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
  • 32. 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
  • 33. 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
  • 34. Un studiu de faza 2b, randomizat, in regim dublu-orb, controlat cu placebo, multicentric, pentru evaluarea eficacitatii si sigurantei astegolimab la pacienti cu boala pulmonara obstructica cronica – 2021
  • 35. Studiu clinic multicentric (MYR204) cu eticheta deschisa randomizat de faza 2b pentru a evalua eficacitatea si siguranta bulevirtidei in combinatie cu interferonul pegilat alfa-2a la pacientii cu hepatita cronica delta – 2019-2023
  • 36. 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
  • 37. 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
  • 38. 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
  • 39. Randomized ,double -blind, placebo-controlled multicenter study to evaluated the efficacy anf safety of Astegolimab in patients with chronic obstructive pulmonary disease. 2022- ongoing
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