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Sentinel lymph node detection of cervical occult lymph node metastases in patients with parotid gland carcinoma by means of sentinel node biopsy using 68-galium-tilmanocept PET-CT.

This study has been transitioned to CTIS with ID 2024-514233-37-00 check the CTIS register for the current data. To evaluate the feasibility and prove the concept of sentinel node biopsy in patients with carcinoma of the parotid gland and scheduled…

A prospective, lead-in study to collect bleeding episodes, Factor VIII (FVIII) infusions, and patient-reported outcomes in patients with hemophilia A

This is a so-called *lead-in study* in which patients receive their standard treatment and no study treatment. The researchers will collect dataabout the patients* bleeding episodes, FVIII containing treatments used to prevent bleeding episodes and…

A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT)

Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…

A phase 3 extension trial of DELTA 1 and DELTA 2 to evaluate the long-term safety of a twice-daily treatment with delgocitinib cream 20 mg/g as needed for up to 36 weeks in adult subjects with chronic hand eczema (DELTA 3)

Primary objective:To evaluate the long-term safety of an as-needed treatment with twice-daily applications of delgocitinib cream 20 mg/g.Secondary objective:To evaluate the long-term efficacy of an as-needed treatment with twice-daily applications…

A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)

This study has been transitioned to CTIS with ID 2023-507146-91-00 check the CTIS register for the current data. Primary Objective:• To evaluate the safety and tolerability of viltolarsen administered intravenously (IV) at weekly doses of 80 mg/kg…

Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD)

The aim of the follow-up study is to determine the differences between early versus late treatment with GZ / SAR402671 in the effect on total kidney volume growth (total kidney volume, TKV) and in the effect on slowing down renal impairment (change…

A MULTICENTER, OPEN-LABEL EXTENSION
STUDY TO EVALUATE THE LONG-TERM SAFETY
AND TOLERABILITY OF FARICIMAB IN PATIENTS
WITH NEOVASCULAR AGE-RELATED MACULAR
DEGENERATION

This study will evaluate the long-term safety and tolerability of IVT faricimab in patients with nAMD who have completed either of the Phase III (GR40306 or GR40844) studies. Additional assessments relating to efficacy, pharmacokinetics,…

Positive end-expiratory pressure levels during resuscitation of preterm infants at birth

The specific trial aim is to establish whether the use of a high, dynamic 8-12 cmH2O PEEP level strategy to support the lung during stabilisation at birth, compared with a static 5-6 cmH2O PEEP level strategy, increases the rate of survival without…

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

Primary* The primary objective of this study is to determine the long term safety and tolerability of tofacitinib for treatment of the signs and symptoms of JIA.Secondary* The secondary objective of this study is to evaluate the persistence of…

ABROCITINIB EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADOLESCENTS AND ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Primary:To provide access to abrocitinib to adolescent and adult patients with or without background topical therapy who have inadequate treatment options due to inadequate response or intolerance to available approved medicated topical and systemic…

OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

This study has been transitioned to CTIS with ID 2023-509694-22-00 check the CTIS register for the current data. Primary objective: • To evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely…

A phase III open-label extension study to evaluate long-term safety and efficacy of PRM-151 in patients with Idiopathic Pulmonary Fibrosis (IPF)

Study WA42294 is a Phase III open-label extension (OLE) study to assess the long-term safety, efficacy, and pharmacokinetics of PRM-151 in patients with IPF with or without concurrent treatment with pirfenidone or nintedanib. Patients with IPF who…

Open label extension study for patients with early Alzheimer's Disease (AD) enrolled in study ANAVEX2-73-AD-004

Primary objective:To continue assessing the safety and tolerability of ANAVEX2-73.Safety and Tolerability Measures:* Physical examination* Vital signs (heart rate, respiratory rate, systolic blood pressure [SBP], diastolic blood pressure [DBP],…

18F-fluciclovine PET/CT and 18F-DCFPyL PET/CT in patients with biochemical recurrence of disease after radical prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial.

To head-to-head compare the per patient detection rate of 18F-Fluciclovine PET/CT versus 18F-DCFPyL PET/CT in patients with BCR of disease after radical prostatectomy.

The effect of bile acid binding with colesevelam on postprandial glucose concentrations in patients after RYGB and cholecystectomy : a meal test study

Objective: Primary : To compare the difference in glucose nadir during the MMT on and off pre-treatment with colesevelam in RYGB-CCx patients with a hypoglycaemia (RYGB-CCx-hypo) in the first MMT Secondary:To evaluate the difference in number of…

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 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…

Optimal Booster Strategy for SARS-CoV-2 Vaccination in Kidney Transplant patients

To assess the efficacy (expressed as percentage of responders) of various COVID-19 booster vaccination strategies in kidney transplant patients that failed to mount a sufficient antibody response after two primary doses of the mRNA-1273 vaccine.

Interventional, open-label, fixed-dose multiple administration study to evaluate long-term treatment with eptinezumab in patients with chronic cluster headache

Primary Objective:To evaluate the long-term safety and tolerability of eptinezumab in patients with chronic cluster headache (cCH)Secondary ObjectivesTo evaluate the efficacy of eptinezumab in patients with cCHExploratory ObjectiveTo explore the…

A Phase 3 open-label, multicenter study of the long-term safety and efficacy of intravenous recombinant coagulation factor VIII Fc-von Willebrand factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients with severe hemophilia A

This study has been transitioned to CTIS with ID 2023-508929-27-00 check the CTIS register for the current data. -To evaluate the long-term safety of BIVV001 in previously treated patients with hemophilia A.-To evaluate the efficacy of BIVV001 as a…