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Gabinete de Ensaios Clínicos

Gabinete de Ensaios Clínicos


5 | Ensaios Clínicos/Estudos Observacionais

Promotor

Serviço

Investigador Principal

Ensaio
BAYER MEDICINA INTERNA Drª Maria João Baldo FINEARTS – A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants.
ABBVIE

REUMATOLOGIA

MEDICINA INTERNA

 Drª Claúdia Vaz M16-852 – A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis.
INSMED PNEUMOLOGIA Drª Alcina Tavares ASPEN – A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis.
SANOFI PNEUMOLOGIA Dr. José Manuel Silva AERIFY – Randomized, doub le-blind, placebo-controlled, parallelgroup Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
NOVO NORDISK MEDICINA INTERNA Dr. Adriano Cardoso ESSENCE – The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis
POLYPID CIRURGIA Prof. Doutor Augusto Lourenço D-PLEX – Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two‐arm, Double Blind Study to Assess Efficacy and Safety of D‐PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection.
JANSSEN UNIDADE ONCOLOGIA Drª Inês Sequeira CAPA – Characterization of Castrate-Resistant Prostate Cancer patients followed in Urology Department of Portuguese hospitals.
PFIZER INFECIOLOGIA Drª Catarina Quinaz OZAVIE – A prospective, multicentre, observational study in hospitalized patients suffering from infections and treated with ZAVICEFTA® (ceftazidime/avibactam) under actual conditions of use.
GILEAD UNIDADE ONCOLOGIA Drª Inês Sequeira TROPICS – A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer.
ASTRAZENECA PNEUMOLOGIA Dr. José Manuel Silva LOGOS – A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI) Relative to Budesonide and Formoterol Fumarate MDI and Symbicort® Pressurized MDI in Adult and Adolescent Participants with Inadequately Controlled Asthma.
GSK PNEUMOLOGIA Dr. José Manuel Silva SWIFT – A 52-week, andomized, double-blind, placebo-controlled, parallelgroup, multi-centre study of the efficacy and safety of GSK3511294 adjunctive therapy in adult and adolescent participants with severe uncontrolled asthma with an eosinophilic phenotype.
GSK PNEUMOLOGIA Dr. José Manuel Silva NIMBLE – A 52-week, Randomized, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab.
SEAGEN ONCOLOGIA Drª Inês Sequeira MOUNTAINER – An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzamab and mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer.
NOVARTIS REUMATOLOGIA Drª Cláudia Vaz NEPTUNUS: A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome.

6 | Contatos

Localização:

Gabinete de Ensaios Clínicos (GEC)
Edifício da Consulta Externa, ao lado da papelaria

Contatos:

Emails:

Contato telefónico:

  • Inês Serra: 910 143 853
  • Madalena Oliveira: 964 110 406

4 | BlueClinical

Ensaios Clínicos a decorrer na ULSG com apoio da BlueClinical

Clique aqui para ter conhecimento dos Ensaios Clínicos e Estudos Observacionais que se encontram a decorrer na ULSG.


3 | Missão e Objetivos

Missão

Promover, coordenar e apoiar a realização de ensaios clínicos na ULSG.

Objetivos

  • Estabelecer contacto com os Promotores, Monitores e Autoridades Regulamentares de Ensaios Clínicos;
  • Avaliar a exequibilidade de novos Ensaios Clínicos na ULSG;
  • Acompanhar o processo de submissão e aprovação dos Ensaios Clínicos pelo Conselho de Administração;
  • Coordenar o planeamento e realização dos Ensaios Clínicos na ULSG;
  • Apoiar os Investigadores e Equipas de Investigação na ULSG.

2 | Equipa

Coordenadora do Gabinete de Ensaios Clínicos: Drª Cláudia Vaz, Diretora do Serviço de Reumatologia

Coordenadoras de Ensaios Clínicos da BlueClinical: Drª Inês Serra e Drª Madalena Oliveira

Cláudia Vaz Inês Serra Madalena Oliveira

1 | Apresentação

O Gabinete de Ensaios Clínicos (GEC) visa reforçar o incentivo ao crescimento da investigação e da inovação promovendo o fomento do conhecimento científico e tecnológico.
O processo de inovação que tem o seu início no laboratório, identificando novas moléculas e futuros tratamentos promissores tem um longo caminho a percorrer até chegar à prática clínica.
A ULSG assinou um protocolo de colaboração com a BlueClinical para a dinamização da Investigação Clínica.