Clinical trials: Treatment naïve
Sleep Apnea, Obstructive
Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo
This is a prospective, open-label study to evaluate the effectiveness of providing a dashboard with merged health metrics of CPAP (continuous positive airway pressure/ PAP) usage, self-reported sleepiness, blood pressure (BP) and…
- Trial name
- NCT04912635
- Testing
- Neo App
- Where
- Australia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- ResMed
HIV-1 Infection
Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen
The main purpose of this study was to compare the effects on bones of the following two drug combinations: maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r) tenofovir (TDF) plus emtricitabine (FTC) plus…
- Trial name
- NCT01400412
- Testing
- Darunavir, Ritonavir, Tenofovir disoproxil fumarate
- Where
- 38 sites in United States, Puerto Rico
- Volunteers
- 262 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Adrenal Insufficiency
Effects of Steroid Replacement Therapy on Metabolic, Cardiovascular and Bone Outcomes in Adrenal Insufficiency
The current study is a randomized, open study aimed to compare the effects of conventional glucocorticoid replacement treatment and dual-release hydrocortisone on anthropometric, metabolic, cardiovascular and bone outcomes in…
- Trial name
- NCT06260462
- Testing
- dual-release hydrocortisone, Conventional glucocortidois
- Volunteers
- 88 people
- Sponsor
- University of Palermo
Gaucher Disease
An Open-Label, Dose Escalation Study to Evaluate the Safety and the Pharmacokinetics of Oral PRX-112
This is an open-label, dose escalation study to evaluate the safety of oral PRX-112 and pharmacokinetics of GCD in subjects with Gaucher disease naive to enzyme replacement therapy.
- Trial name
- NCT02107846
- Testing
- PRX-112
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Protalix
Myelodysplastic Syndrome
Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy
This is a dose escalation followed by dose expansion study of TL32711 in combination with 5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have failed prior 5-azacitidine therapy.
- Trial name
- NCT01828346
- Testing
- Birinapant, 5-Azacitidine
- Where
- 7 sites in United States
- Volunteers
- 21 people
- Sponsor
- TetraLogic Pharmaceuticals
Myelodysplastic Syndromes(MDS)
A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)
This phase3 study is a randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of Lemzoparlimab for injection in combination with AZA versus AZA monotherapy as first-line therapy in…
- Trial name
- NCT05709093
- Testing
- Lemzoparlimab+Azacitidine (AZA), Azacitidine (AZA)
- Where
- 44 sites in China
- Volunteers
- 10 people
- Sponsor
- TJ Biopharma Co., Ltd.
Prostate Adenocarcinoma, Prostate Carcinoma
Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion
Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds to prostate cancer cells and can be imaged…
- Conditions
- Prostate Adenocarcinoma, Prostate Carcinoma, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Trial name
- NCT04976257
- Testing
- Angiogram, Catheterization, Gallium Ga-labeled PSMA-11
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Ryan Kohlbrenner, MD
Prostate Cancer
The Effect of ADT on PSMA Expression in Metastatic Prostate Cancer
Thirty-five men with newly diagnosed, metastatic prostate cancer are scanned with 18F-PSMA 1007 PET/CT at baseline, 3 weeks after the initiation of GnRH-antagonist, at one year and at the time of castration resistant prostate…
- Trial name
- ADTPSMA2 (NCT03876912)
- Testing
- GnRH antagonist
- Where
- Finland
- Volunteers
- 35 people
- Sponsor
- Turku University Hospital
Ovarian Neoplasm
Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer
The primary objective of this sub study is to evaluate the efficacy of the combination of TSR-042, bevacizumab, and niraparib in participants with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal…
- Trial name
- COHORT-A (NCT05751629)
- Testing
- Dostarlimab, Bevacizumab, Niraparib
- Where
- 10 sites in United States
- Volunteers
- 41 people
- Sponsor
- Tesaro, Inc.
Diabetes Mellitus, Type II
Effectiveness & Tolerability of Novel, Initial Triple Combination Therapy vs Conventional Therapy in Type 2 Diabetes
In this study, the investigators will assess the efficacy and tolerability of a novel, initial triple combination therapy with metformin, saxaglipitin, and dapagliflozin, compared to conventional stepwise add-on therapy in…
- Trial name
- NCT02946632
- Testing
- triple combination therapy, Stepwise add-on therapy
- Where
- South Korea
- Volunteers
- 104 people
- Sponsor
- Korea University Anam Hospital
Age-related Macular Degeneration
Analysis of naïve Patients With Age-related Macular Degeneration of the Neovascular Type and Treated With Aflibercept (Eylea®) in "Treat-and-extend" at CHU Brugmann
Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50. Neovascular AMD, the most serious and severe form, is characterized by the appearance, spread and growth of subretinal new vessels.
- Trial name
- NCT04891835
- Testing
- Data extraction from medical files
- Where
- Belgium
- Volunteers
- 36 people
- Sponsor
- Laurence Postelmans
Hepatitis C, Chronic
A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis
This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus…
- Trial name
- NCT01749150
- Testing
- danoprevir + ritonavir, peginterferon alfa-2a [Pegasys], ribavirin [Copegus]
- Where
- 13 sites in South Korea, Taiwan and 1 more
- Volunteers
- 61 people
- Sponsor
- Hoffmann-La Roche
NSCLC
Pathological and Nuclear Medicine Factors for Prognosis in Lung Carcinoma
Retrospective study in patients with therapy-naive non small cell lung carcinoma correlating presurgical F18-FDG-PET/CT imaging texture analysis data with postsurgical molecular pathology data and clinical patient outcome.
- Trial name
- PANU (NCT04276025)
- Testing
- Clinical routine F18-FDG-PET/CT, molecular pathology and clinical outcome
- Volunteers
- 2,000 people
- Sponsor
- Klinikum Bayreuth GmbH
Chronic Lymphocytic Leukemia
TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL)
The purpose of this study is to see how safe and effective the investigational drug umbralisib (TGR-1202) is in individuals with Chronic Lymphocytic Leukemia (CLL)
- Trial name
- NCT04163718
- Testing
- Umbralisib
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Type 1 Diabetes
Study of the Effects of Carbohydrate Counting
The investigators hypothesize that non-optimally treated carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates and that the metabolic control can be further…
- Trial name
- NCT01223547
- Testing
- Education
- Where
- Denmark
- Volunteers
- 64 people
- Sponsor
- Hvidovre University Hospital
Fabry Disease
A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms
The purpose of this study was to determine whether 2 alternative dosing regimens of Fabrazyme (Agalsidase beta) (1.0 mg/kg every 4 weeks or 0.5 mg/kg every 2 weeks) were effective in treatment-naïve pediatric participants without…
- Trial name
- FIELD (NCT00701415)
- Testing
- Agalsidase beta
- Where
- 12 sites in United States, Argentina and 7 more
- Volunteers
- 31 people
- Sponsor
- Genzyme, a Sanofi Company
Hepatitis C, HCV
TD-6450 MAD Study in HCV Infected Subjects
This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.
- Trial name
- NCT02116543
- Testing
- TD-6450
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Theravance Biopharma
Lung Cancer
Gefitinib in Treating Patients With Previously Untreated Stage IIIB or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with previously untreated…
- Trial name
- NCT00411047
- Testing
- gefitinib
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Massachusetts General Hospital
EGFR Mutated EGFR TKI Naive Metastatic NSCLC
Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)
This study will evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of momelotinib (MMB) and erlotinib, as well as define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with erlotinib in adults…
- Trial name
- NCT02206763
- Testing
- Momelotinib (MMB), Erlotinib
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Sierra Oncology LLC - a GSK company
Hepatitis C
Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects
The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C.
- Trial name
- NCT01200420
- Testing
- miravirsen, saline
- Where
- 7 sites in United States, Germany and 4 more
- Volunteers
- 38 people
- Sponsor
- Santaris Pharma A/S