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LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS

This study has been transitioned to CTIS with ID 2023-504201-36-00 check the CTIS register for the current data. Per Health Authority guidelines for gene therapy medicinal products that utilize integrating vectors (eg, lentiviral vectors), long-term…

IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH).

The objective of the study is to establish an optimal dose of AV-101 based primarily upon the change in PVR but also other efficacy, safety, and tolerability findings from the Phase 2b Part of the study. The optimal dose will be taken into the Phase…

A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

This study has been transitioned to CTIS with ID 2024-512606-25-00 check the CTIS register for the current data. Primary Objective phase 2 part of the study- To determine the confirmed Objective Response Rate (ORR) as assessed by Blinded Independent…

An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias or Solid Tumors in Pediatric Participants.

This study has been transitioned to CTIS with ID 2023-509699-41-00 check the CTIS register for the current data. Primary objectives:Phase 1: To determine the MTD and/or RP2D of oral ponatinib administered QD in pediatric participants with selected…

Phase 1/2 Dose Finding, Safety and Efficacy Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)

This study has been transitioned to CTIS with ID 2023-507330-24-00 check the CTIS register for the current data. Part A - Dose Finding/SafetyPrimary Objective:* To determine the recommended pediatric equivalent dose (RPED; based on pharmacokinetic […

Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours

This study has been transitioned to CTIS with ID 2024-514238-19-00 check the CTIS register for the current data. The general purpose of the study is to find personalized cancer treatment based on genetic analysis of tumors.

Early high-dose vitamin C in post-cardiac arrest syndrome.

Objectives:- To determine whether an early high dose i.v. vitamin C can improve organ function, especially neurological outcome, in patients after cardiac arrest- To explore the optimal dosing regimen for high dose i.v. vitamin C- To investigate in…

Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or Durvalumab in Combination with Tremelimumab in Pediatric Patients with Advanced Solid Tumors and Hematological Malignancies

Dose-finding:-To determine the adult equivalent exposure/MTD/recommended Phase II pediatric dose of durvalumab monotherapy and durvalumab in combination with tremelimumab-To determine the safety profile of durvalumab monotherapy, or durvalumab in…

A Phase IIb, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of partial deep dermal and full thickness burns in children in comparison to autologous split-thickness skin grafts (STSG)

To evaluate the efficacy and safety of EHSG-KF in comparison to meshed STSG in children with partial deep dermal and full thickness burns. Primary Objective: To evaluate the efficacy of EHSG-KF in comparison to meshed STSG based on:• Ratio of…

THE IMPACT OF PSILOCYBIN ON PAIN IN FIBROMYALGIA PATIENTS:
A MULTICENTER TRIAL

This study has been transitioned to CTIS with ID 2024-516890-63-00 check the CTIS register for the current data. Primary Objective: The primary objective is to assess the effects of low psilocybin doses on pain perception in FM patients and their…

Glycocalyx restoration in treatment resistant hypertension: a proof of concept, randomized, double-blind, placebo-controlled study

Primary Objective: • To assess whether the food supplement Endocalyx lowers blood pressure in patients with treatment resistant hypertension.Secondary Objectives: • To study the effect of Endocalyx on office blood pressure and 24-hour blood pressure…

Phase II study examining the activity of L19-IL2 immunotherapy and stereotactic ablative radiotherapy in metastatic non-small cell lung cancer

The purpose of this scientific study is to verify whether immunotherapy (L19-IL2) after a standard treatment such as radiotherapy, fights the metastatic disease more efficiently than the current standard treatment alone.

A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults with Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

This study has been transitioned to CTIS with ID 2023-506136-32-00 check the CTIS register for the current data. Primary:Dose Escalation• Evaluate the safety and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory…

A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis.

This study has been transitioned to CTIS with ID 2024-512964-73-00 check the CTIS register for the current data. The overall objective is to investigate the safety, tolerability, efficacy and pharmacokinetics of R3R01 administered daily for 3 months…

A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis

This study has been transitioned to CTIS with ID 2024-516728-32-00 check the CTIS register for the current data. To determine RD of elenestinibTo assess if treatment with elenestinib improves outcomes compared to placebo + BSC, as assessed using the…

First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors

This study has been transitioned to CTIS with ID 2024-510722-10-00 check the CTIS register for the current data. • Evaluate antitumor activity based on response assessment criteria (RECIST v1.1)• Determine RP2D (unless determined in the Escalation…

PROSPER: Addressing mental health problems and preventing recidivism in the criminal justice system

The primary aim of this study is to investigate the feasibility, acceptability and user-friendliness of implementing PM+ in Dutch prisons. This is a version of PM+ that is specifically adapted to the prisoner population and prison context. The…

A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS
PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI-H/DMMR METASTATIC COLORECTAL CANCER

This study has been transitioned to CTIS with ID 2024-512119-34-00 check the CTIS register for the current data. Comparing the efficacy of encorafenib and cetuximab plus pembrolizumab (triplet group [group A]) vs. pembrolizumab (control group [group…

An exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease (ADPKD).

Main objective- To characterize the effect of GLPG2737 on growth in total kidneyvolume (TKV) compared to placebo.- To evaluate the safety and tolerability of oral doses of GLPG2737compared to placebo.Secondary objectives: - To characterize the…

A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 (001)

Primary Objectives:• To characterize the safety and tolerability and to identify the recommended Phase 2 dose (RP2D) of ALKS 4230 administered subcutaneously (SC) as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced…