Clinical trials: in Denmark
R/R AML, R/R HR-MDS
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety.
- Conditions
- R/R AML, R/R HR-MDS, Acute Myeloid Leukemia, Higher-Risk Myelodysplastic Syndrome
- Trial name
- NCT07384715
- Testing
- GEN3018
- Where
- 9 sites in Denmark, Italy and 1 more
- Volunteers
- 78 people
- Sponsor
- Genmab
Atrial Fibrillation
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with…
- Trial name
- VP-CONFIRM (NCT07429214)
- Testing
- Pulsed Field Ablation System
- Where
- 6 sites in Belgium, Denmark and 3 more
- Volunteers
- 42 people
- Sponsor
- Biosense Webster, Inc.
Primary Myelofibrosis
Extended Access of Momelotinib in Adults With Myelofibrosis
This is an extended-access, long-term safety study for participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) who have not…
- Trial name
- NCT03441113
- Testing
- Momelotinib
- Where
- 112 sites in United States, Australia and 18 more
- Volunteers
- 237 people
- Sponsor
- GlaxoSmithKline
Bladder Tumors, Bladder Tumor
Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial
This phase I study evaluates intravesical calcium electroporation (CaEP) with a new transurethral electrode. The study is primarily designed to assess the safety of CaEP and secondarily, to preliminary explore the efficacy in…
- Conditions
- Bladder Tumors, Bladder Tumor, Urothelial Carcinoma (UC), Urothelial Carcinoma Bladder
- Trial name
- CALCIFER (NCT07555769)
- Testing
- Calcium electroporation, Intratumoral calcium injection, Transurethral electroporation
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Juan Luis Vásquez
Preterm Birth, Artificial Intelligence (AI) in Diagnosis
Does AI Make Clinicians More Appropriately Confident? A Randomized Study in Preterm Birth Prediction
The goal of this randomized questionnaire-based study is to evaluate how different presentations of artificial intelligence (AI) decision support influence clinical judgment among medical doctors working in obstetrics and…
- Trial name
- NCT07402668
- Testing
- AI prediction (binary), AI risk estimate (%)
- Where
- 18 sites in Denmark
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Hot Flashes
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
One of the standard treatments for women with breast cancer is hormone therapy, but this treatment can cause hot flashes. Hormone replacement therapy, or HRT, is most often prescribed for hot flashes for women in menopause but…
- Trial name
- NCT06440967
- Testing
- Fezolinetant, Tamoxifen, Aromatase inhibitor
- Where
- 110 sites in Canada, Czechia and 9 more
- Volunteers
- 982 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Hematologic Malignancies, Waldenstroms Macroglobulinaemia
Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's…
- Conditions
- Hematologic Malignancies, Waldenstroms Macroglobulinaemia, Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukaemia
- Trial name
- NCT04728893
- Testing
- Nemtabrutinib
- Where
- 121 sites in United States, Argentina and 20 more
- Volunteers
- 490 people
- Sponsor
- Merck Sharp & Dohme LLC
Aortic Valve Stenosis
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking.
- Trial name
- REVALVE (NCT06557798)
- Testing
- Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication, Surgical explantation and aortic valve replacement, Conservative management
- Where
- 63 sites in Denmark, Finland and 9 more
- Volunteers
- 550 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Insertion of a Flexible Bronchoscope, Airway Management When Secretions Obstruct the Larynx
Oxygen Insufflation Via Flexible Scope
The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way.
- Trial name
- OxyInsuffl (NCT06680648)
- Testing
- addition of oxygeninsufflation via working channel of flexible scope, no-oxygen insufflation
- Where
- Denmark
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Alpha 1 Antitrypsin Deficiency
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein.
- Trial name
- SWIFT-SC (NCT07555483)
- Testing
- Alpha-1 15%, Liquid Alpha1-PI
- Where
- 22 sites in United States, Denmark and 7 more
- Volunteers
- 40 people
- Sponsor
- Grifols Therapeutics LLC
Pulmonary Hypertension, Interstitial Lung Disease
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.
- Trial name
- PALM-ILD (NCT07179380)
- Testing
- Treprostinil Palmitil Inhalation Powder
- Where
- 186 sites in United States, Argentina and 28 more
- Volunteers
- 344 people
- Sponsor
- Insmed Incorporated
Hormone Sensitive Prostate Cancer, Prostate Cancer
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.
- Conditions
- Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
- Trial name
- NCT02319837
- Testing
- Enzalutamide, Leuprolide Open Label
- Where
- 255 sites in United States, Australia and 15 more
- Volunteers
- 1,068 people
- Sponsor
- Pfizer
Homozygous Familial Hypercholesterolemia
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
This study will evaluate the efficacy and safety of zodasiran subcutaneous (sc) injection in participants 12 to <18 years of age with genetically or clinically diagnosed homozygous familial hypercholesterolemia (HoFH) and…
- Trial name
- SPRUCE (NCT07473843)
- Testing
- Zodasiran
- Where
- 3 sites in United States, Denmark and 1 more
- Volunteers
- 10 people
- Sponsor
- Arrowhead Pharmaceuticals
Hidradenitis Suppurativa
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
- Trial name
- BE HEARD I (NCT04242446)
- Testing
- Bimekizumab
- Where
- 88 sites in United States, Australia and 13 more
- Volunteers
- 505 people
- Sponsor
- UCB Biopharma SRL
B-Cell Acute Lymphoblastic Leukaemia
International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)
The IntReALL BCP 2020 study aims to review recent developments and findings regarding chemoimmunotherapy with inotuzumab and immunotherapy with blinatumomab and to increase the use of promising new immunotherapeutic drugs as…
- Trial name
- NCT07476729
- Testing
- Inotuzumab ozogamicin (INO), Blinatumomab
- Where
- 21 sites in Austria, Belgium and 19 more
- Volunteers
- 750 people
- Sponsor
- Charite University, Berlin, Germany
Microscopic Colitis
A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
This is a parallel, placebo-controlled, multicenter, randomized, double-blind, Phase 2, proof of concept study. The study aims to evaluate the efficacy and safety of SAR444336 in adult participants with microscopic colitis.
- Trial name
- NCT07156175
- Testing
- SAR444336
- Where
- 24 sites in Belgium, Denmark and 7 more
- Volunteers
- 54 people
- Sponsor
- Sanofi
Obesity & Overweight
Changes in Intestinal Permeability and Systemic Inflammation Following Fast Food Overfeeding.
The purpose of this study is to investigate whether lifestyle factors can alter gut barrier integrity and whether disruptions of the gut barrier can trigger systemic and tissue-specific inflammation.
- Trial name
- ChIPS (NCT07893743)
- Testing
- Fast-food overfeeding
- Where
- Denmark
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Gentofte, Copenhagen
Chronic Thromboembolic Pulmonary Hypertension, CTEPH
TrEatment Approach in the Multimodal Era Registry
The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH).
- Trial name
- TEAM (NCT05629052)
- Testing
- Pulmonary endarterectomy, Balloon pulmonary angioplasty, Pulmonary hypertension (PH)-specific medication
- Where
- 25 sites in United States, Argentina and 18 more
- Volunteers
- 1,000 people
- Sponsor
- International CTEPH Association
Bipolar Disorder Type I With Mania
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the…
- Trial name
- NCT06929273
- Testing
- KarXT, Lithium, Valproate
- Where
- 184 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Bristol-Myers Squibb
Urothelial Cancer
A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer
This study will evaluate the safety of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are…
- Trial name
- NCT05645692
- Testing
- Atezolizumab, Tobemstomig, Tiragolumab
- Where
- 56 sites in United States, Australia and 13 more
- Volunteers
- 204 people
- Sponsor
- Hoffmann-La Roche