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Safety and protective efficacy of BCG vaccination against controlled human malaria infection

The primary objective is to determine the safety and tolerability BCG vaccination followed by controlled human malaria infection; and to determine the protective efficacy BCG vaccination against a controlled human malaria infection.

A Phase 2, Single dose, Open-Label, Exploratory Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

4.1 Primary• To estimate the Sensitivity and False Positive rate of OTL38 for malignancy detection during Near Infrared Imaging (NIR).• To assess the safety and tolerability of single intravenous doses of OTL384.2 Secondary• To assess the safety of…

A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (DLB).

Primary• To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician*s Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment• To assess the effects of RVT-101 versus…

Effectiveness of Somatostatin Analogues in patients with Gastric antral
vascular ectasia and symptomatic gastrointestinal bleeding: SAGAVE-trial

Primary Objective: To investigate the efficacy and safety of octreotide treatment (a somatostatin analogue) in decreasing the transfusion requirements (IV iron infusions and / or red blood cell transfusions) in patients with GI bleeding caused by…

An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies with HRAS Mutations.

Primary objective: To determine the antitumor activity regarding objective response rate (ORR) of tipifarnib in subjects with locally advanced non-resectable or metastatic, relapsed and/or refractory, non-haematological malignancies with HRAS…

A randomized and open-label dose-finding, phase 2, efficacy, safety and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO TM versus pegfilgrastim (NeulastaR) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN)

Primary Objective:- To assess the efficacy of escalating doses of ANF-RHO versus Neulasta in the duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the first chemotherapy cycle (21-day cycle FE100C).Secondary…

A Randomised Phase II Study of Nintedanib (BIBF1120) Compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium

The objectives are to assess the efficacy, safety and effect on quality of life of Nintedanib compared to chemotherapy in women with relapsed, advanced or metastatic clear cell cancer of the ovary of endometrium.

Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event
International, multi-centre, randomized, double-blind placebo-controlled phase II study.

Efficacy and safety trial with S 44819 after recent ischemic cerebral Event

Bumetanide to Ameliorate Tuberous Sclerosis Complex Hyperexcitable Behaviors

Primary aim: to confirm that treatment with bumetanide improves daily life functioning and reduces behavioral symptoms related to hyperexcitability in children and adolescents with TSC.Secondary aim: to identify neurophysiological and cognitive…

A Randomized Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects with Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT).

Primary Objective:Efficacy:· Evaluate the efficacy of subcutaneous (sc) azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in the defined study population.Secondary Objectives:Safety:· Assess the safety and…

Adjuvant hepatic arterial infusion pump chemotherapy after repeat hepatectomy for patients with recurrent colorectal liver metastases without a history of extrahepatic disease - a phase II study

Primary Objective: The first objective of this study is to evaluate efficacy of adjuvant HAIP chemotherapy after repeat hepatectomy for recurrent CRLM in the Erasmus MC.Secondary Objective(s): The second objective is to determine treatment related…

Cardiac CT for therapeutic stratification in low gradient presumed severe aortic stenosis with preserved left ventricular ejection fraction

Primary objective: The primary objective of this non-randomized intervention trial is to investigate whether TAVR improves exercise capacity in patients with preserved LVEF and NF/LG or LF/LG severe AS reclassified based on hybrid CT/TTE-derived…

An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

To evaluate the dose response relationship of LNP023 on the reduction in proteinuria versus placebo after 90 days of treatment in patients with IgA nephropathy.

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the
Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus

Primary ObjectiveFor Part 1:The primary objective is to characterize the pharmacokinetics (PK) and to confirm the population PK (popPK) model derived from healthy volunteers in hospitalized adults who are infected with RSV.For Part 2:The primary…

Track and treat in NSCLC (TATIN) - ctDNA guided treatment of early resistance to targeted treatment in patients with EGFR positive NSCLC

Primary objectives• To identify the percentage of patients in which a drug resistant clone can be detected with ctDNA before the emergence of radiological progression.• To determine the success rate of crizotinib and osimertinib combination…

A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination with Ipilimumab versus Nivolumab in combination with Ipilimumab placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The aim of the study is to compare the Overall Response Rate (ORR) and assess Duration of Response (DoR) of the treatment of nivolumab in combination with ipilumumab vs. nivolumab in combination with ipilimumab placebo, as determined by a blinded…

A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Dementia with Lewy Bodies (DLB)

To assess the long-term safety and tolerability of 35 mg and 70 mg RVT-101 in subjects with DLB

Adult mesenchymal stromal cells to regenerate the neonatal brain: the PASSIoN trial (Perinatal Arterial Stroke treated with Stromal cells IntraNasally)

This study will assess safety and feasibility of bone marrow-derived allogeneic MSCs, as administered by the nasal route, in neonates who suffered from PAIS. The ultimate goals of the present study is therefore to develop a therapy using adult human…

An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer

The objectives and relevant endpoints of the study are as follows:Primary: To assess the safety and tolerability of ATL001 as amonotherapy and in combination with pembrolizumabSecondary: To evaluate the clinical efficacy of ATL001treatment as a…

A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN -145) in Patients with Metastatic Non-Small-Cell Lung Cancer

This study has been transitioned to CTIS with ID 2024-510778-26-00 check the CTIS register for the current data. Primary Objective:To evaluate the efficacy of LN-145 measured by objective response rate (ORR) usingResponse Evaluation Criteria in…