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An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals with Angelman Syndrome (ELARA)

The primary objective of this study is to evaluate the long-term safety and tolerability of OV101 in individuals with AS assessed by the incidence and severity of AEs and SAEs in subjects who are at least 2 years old.The secondary objectives of this…

Prostate Cancer Imaging with [18Flourine]Prostate Specific Membrane Antigen (PSMA) PET: a study on pharmacokinetics and test repeatability

The present study aims to:A) acquire a pharmacokinetic model of [18F]PSMA ([18F]-DCFPyl), by which simplified methods to quantify [18F]PSMA PET signal will be validated ; andB) assess the repeatability of those simplified quantitative method.

rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study

* The purpose of this study is to to determine the safety profile of long-termCoversin treatment.* To observe the long term safety and efficacy of Coversin over periods in excess of 6 months* To assess the long term patient acceptability of Coversin…

Phase 3b Study for Management of Ocular Side Effects in Subjects with EGFR-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)

This exploratory study is designed to evaluate several depatuxizumab mafodotin-related OSE management strategies.The main objective of this trial is to estimate the percentage of subjects in each prophylactic treatment arm who require a change in…

Effects of oral levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002

Is to evaluate long-term safety of oral levosimendan in amyotrophic lateral sclerosis (ALS) patients.

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) PET ligand in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy

To assess the patient level CDR and region level PPV of rhPSMA-7.3 (18F) PET for BCR of PCa using histopathology or imaging as a SoT. Secondary Objectives: 1. To assess the patient level CDR and region level PPV of rhPSMA-7.3 (18F) PET in the…

A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of;Subcutaneously Administered Ustekinumab in the Treatment of Moderate;to Severe Chronic Plaque Psoriasis in Pediatric Subjects greater than 6 to less than 12 Years of Age

Primary Objective• To evaluate the efficacy and safety of ustekinumab in pediatric subjects aged >=6 through <12 years with moderate to severe chronic plaque psoriasis.Major Secondary Objectives• To evaluate the pharmacokinetics (PK)…

A Multicenter Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Bempedoic Acid (ETC-1002) 180 mg

Primary:* To characterize the safety and tolerability of long-term administration of bempedoic acid (ETC-1002) 180 mgSecondary:* To characterize the efficacy of long-term administration of bempedoic acid 180 mg/day as assessed by changes in low-…

AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS

The main objective of this trial is to investigate safety of long term use of inhaled molgramostim by collecting information on the side effects.

An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

This study will evaluate the efficacy and safety of ocrelizumab in patients with early stage relapsing remitting multiple sclerosis (RRMS).The objective of the Immune Substudy is to explore immunological changes associated with ocrelizumab treatment…

A 104-Week, Multicenter, Single-Arm, Long-Term, Phase 3 Extension Trial Investigating the Safety and Efficacy of Glepaglutide in Adult Patients with Short Bowel Syndrome (SBS) Completing the EASE SBS 2 Trial

This study has been transitioned to CTIS with ID 2024-513373-43-00 check the CTIS register for the current data. The objectives of this extension trial are to assess the long-term safety and maintenance of efficacy beyond 2 to 2.5 years of treatment…

A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism

To evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF subjects with impaired glucose tolerance (IGT) or CF related diabetes (CFRD)

OPEN-LABEL PHASE 2/3 CLINICAL STUDY TO INVESTIGATE SAFETY AND IMMUNOGENICITY OF A SINGLE VLA2001 BOOSTER VACCINATION IN ADULT VOLUNTEERS, AFTER RECEIPT OF NATIONALLY ROLLED OUT MRNA COVID-19 VACCINES AND/OR NATURAL SARS-COV-2 INFECTION

Immunogenicity:To determine the immune response in terms of GMT fold-rise for neutralising antibodies against SARS-CoV-2 following a single booster dose with VLA2001Safety:To assess tolerability of a VLA2001 booster vaccination

Pentoxifylline dose optimization in preterm neonatal sepsis

The main objective is to determine in what optimal dose PTX should be used in preterm infants suffering from sepsis. Previous clinical studies have already indicated the safety of the drug in preterm infants.

A Phase 3, Open-label, Long-term Safety Study of Oral Linaclotide Administered to Pediatric Participants with Functional Constipation (FC) or Irritable Bowel Syndrome with Constipation (IBS-C)

The objective of this study is to assess the long-term safety of linaclotide in pediatric participants with FC (total exposure with linaclotide for 24 weeks) or IBS-C (total exposure with linaclotide for 52 weeks) who have completed study…

A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes

This study has been transitioned to CTIS with ID 2024-515637-14-00 check the CTIS register for the current data. To evaluate the long-term safety and tolerability of elexacaftor(ELX)/tezacaftor (TEZ)/ivacaftor (IVA)

Validation of ICG-99mTc-nanoscan as hybrid tracer for sentinel node biopsy

This study has been transitioned to CTIS with ID 2024-519351-28-00 check the CTIS register for the current data. Cross validation of the hybrid tracer ICG 99 Tc Nanoscan with respect to 99m Tc Nanoscan for the determination. In particular the…

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis

This study has been transitioned to CTIS with ID 2024-514502-31-00 check the CTIS register for the current data. The primary objective is to assess the long-term safety of nemolizumab (CD14152) insubjects with prurigo nodularis (PN).The secondary…

A phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of Pegcetacoplan in subjects with geographic atrophy secondary to age-related macular degeneration

This study has been transitioned to CTIS with ID 2024-512945-18-00 check the CTIS register for the current data. Objectives:Primary: To evaluate the long-term safety of IVT injected pegcetacoplanSecondary:1. To assess changes in the total area of…

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Homozygous or Heterozygous for the F508del Mutation

Primair eindpunt:Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Homozygous or Heterozygous for the F508del Mutation.Secundair eindpunt:Evaluate the long-term efficacy of VX-…