Clinical trials: Generations
Acute Myeloid Leukemia, Adult, Myelodysplastic Syndromes
First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients
This First In Human (FIH) study is a prospective, open-label, multicenter, Phase 1 study, with a dose escalation design, followed by an optimized design.
- Trial name
- ODYSSEY (NCT05601726)
- Testing
- ABD-3001
- Where
- 3 sites in France
- Volunteers
- 36 people
- Sponsor
- Advanced BioDesign
Urologic Diseases
Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
The purpose of this study is to assess the bioequivalence of the second generation dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available commercial combination of dutasteride 0.5 milligram…
- Trial name
- NCT02052713
- Testing
- Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg, Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule
- Where
- United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Coronary Artery Disease
Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.
- Trial name
- NCT00777842
- Testing
- GTX™ Drug Eluting Coronary Stent System
- Where
- Germany
- Volunteers
- 19 people
- Sponsor
- Cook Group Incorporated
Healthy
Bioequivalence of Two Different Generations of Drug Product of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers
The objective was to demonstrate the bioequivalence of capsules made from 2 different drug product batches. The reference batch was representative of the current commercial drug product and of the pivotal Phase III batches.
- Trial name
- NCT02171520
- Testing
- Dabigatran etexilate generation I, Dabigatran etexilate generation II
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Covid19
Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability…
- Trial name
- COMET-PEAK (NCT04779879)
- Testing
- Sotrovimab (Gen1), Sotrovimab (Gen2)
- Where
- 31 sites in United States, Canada and 3 more
- Volunteers
- 354 people
- Sponsor
- Vir Biotechnology, Inc.
Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate…
- Trial name
- NCT06136650
- Testing
- Opevesostat, Dexamethasone, Fludrocortisone acetate
- Where
- 330 sites in United States, Australia and 37 more
- Volunteers
- 1,314 people
- Sponsor
- Merck Sharp & Dohme LLC
Colorectal Cancer
Tempus CRC Surveillance Study: A ctDNA Biomarker Profiling Study of Patients With CRC Using NGS Assays
The study is an observational multicenter evaluation of participants with colorectal cancer (CRC) who will receive longitudinal plasma ctDNA biomarker profiling in addition to their standard-of-care therapy and disease…
- Trial name
- NCT05234177
- Testing
- Observation
- Where
- 20 sites in United States
- Volunteers
- 300 people
- Sponsor
- Tempus AI
Healthy
A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer
The primary purpose of this study is to demonstrate the equivalence of budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with a spacer to BGF MDI hydrofluoroalkane (HFA) with a…
- Trial name
- NCT06340581
- Testing
- Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO, Treatment C: BGF MDI HFO
- Volunteers
- healthy volunteers welcome
- Sponsor
- AstraZeneca
Respiratory Insufficiency, Respiratory Failure
Vela Generation II: Usability and Performance of a Non-Invasive Ventilation Mask.
Study Overview The goal of this clinical trial is to learn whether an improved non invasive ventilation mask with airway washout can reduce how often people need to breathe and perform as well as standard NIV masks when used with…
- Trial name
- NCT07484802
- Testing
- NIV interface with airway washout
- Volunteers
- 60 people
- Sponsor
- Fisher and Paykel Healthcare
Ultrasound Use in Emergency/Medical Care
Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Canada
The purpose of the study is to collect images data sets from clinical cases and periodic user feedback on the Next Generation Venue ultrasound system under clinical conditions.
- Trial name
- NCT03653572
- Testing
- Ultrasound exam
- Where
- Canada
- Volunteers
- 35 people
- Sponsor
- GE Healthcare
Chronic Liver Disease (CLD), Healthy Volunteers
Equivalence of New Breath AnalyzerCompared to Currently BreathID System in Assessment of Liver Function
The aim of the study is to confirm that the new generation state of the art breath analyzer gives equivalent results to the previous model of the Exalenz breath analyzer.
- Trial name
- NCT02187601
- Testing
- MPBA System, BreathID
- Where
- Israel
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Meridian Bioscience, Inc.
Tuberculosis
Evaluation of the QuantiFERON-TB Test.
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
- Trial name
- NCT02142894
- Testing
- CST001
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Neoplasms
Safety Study of an Antisense Product in Prostate, Ovarian, NSCL, Breast or Bladder Cancer
This study is for patients with cancer who have failed potentially curative treatments or for whose disease a curative treatment does not exist.
- Trial name
- NCT00487786
- Testing
- OGX-427, Docetaxel
- Where
- 3 sites in United States, Canada
- Volunteers
- 64 people
- Sponsor
- Achieve Life Sciences
Growth Hormone Deficiency
IGF1 Generation Test
To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.
- Trial name
- CAREL (NCT00145457)
- Testing
- Blood sample, Radiography
- Where
- 8 sites in France
- Volunteers
- 82 people
- Sponsor
- Pfizer
Septoplasty
Safety and Performance of ENTACT Septal Staple System for Septoplasty
This is a prospective, multi-center, single arm PMCF study to evaluate the safety and performance of the ENTACT (Next Generation) resorbable staple system for septoplasty in 40 subjects.
- Trial name
- NCT04392583
- Testing
- ENTACT Septal Staple system
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Solid Tumours
A Worldwide Cancer Registry Enrolling Participants Profiled With a Next-Generation Sequencing Test
WAYFIND-R is a registry that aims to capture high-quality real-world data linking next-generation sequencing, treatments and outcomes from cancer patients diagnosed with a solid tumour.
- Trial name
- NCT04529122
- Where
- 136 sites in Argentina, Austria and 30 more
- Volunteers
- 7,864 people
- Sponsor
- Hoffmann-La Roche
Prostatic Neoplasms
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received…
- Trial name
- NCT03834506
- Testing
- Pembrolizumab, Docetaxel, Prednisone
- Where
- 215 sites in United States, Argentina and 19 more
- Volunteers
- 1,030 people
- Sponsor
- Merck Sharp & Dohme LLC
Infertility
Comparison of Frozen-thawed Embryo Transfers and Fresh Embryo Transfers With Whole Chromosome Analysis Using Next Generation Sequencing
The investigators propose to perform a clinical randomized trial to evaluate the effect of a frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation rates; with the added benefit of a blastocyst…
- Trial name
- NCT02000349
- Testing
- PGD
- Where
- United States
- Volunteers
- 186 people
- Sponsor
- Reprogenetics
Chronic Spontaneous Urticaria (CSU)
A Phase Ib/IIa Study Assessing the Rapid Onset Characteristics of TLL-018 for Moderate-to-Severe CSU With Inadequate Response to Second-Generation H1 Antihistamines
The goal of this clinical trial is to evaluate the rapid onset characteristics of TLL-018 in moderate-to-severe CSU with inadequate response to second-generation H1 antihistamines.
- Trial name
- NCT07665996
- Testing
- TLL-018
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
Contraception
A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)
The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant.
- Trial name
- NCT00620035
- Testing
- Radiopaque Etonogestrel Implant
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- Organon and Co