Clinical trials: Treatment naïve
Leukemia
Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)
To learn if the combination of pirtobrutinib (also called LOXO-305), venetoclax, and obinutuzumab is safe and effective when given to patients with chronic lymphocytic leukemia (CLL) or Richter transformation (RT) who have not…
- Trial name
- NCT05536349
- Testing
- Pirtobrutinib, Obinutuzumab, Venetoclax
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- M.D. Anderson Cancer Center
Hypertension, Pulmonary
A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).
The Study Hypothesis: Aggressive, upfront, dual therapy for treatment-naïve NYHA I/II/III PAH is superior to a traditional "step-up" approach. The study will evaluate: 1.
- Trial name
- NCT01305252
- Testing
- treprostinil inhalations, tadalafil
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Stanford University
Relapse Remitting Multiple Sclerosis
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes.
- Trial name
- AGNOS (NCT05084638)
- Testing
- Ofatumumab
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Chronic HCV Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants…
- Trial name
- NCT02021656
- Testing
- LDV/SOF
- Where
- 45 sites in China, South Korea and 1 more
- Volunteers
- 384 people
- Sponsor
- Gilead Sciences
Adenocarcinoma of the Prostate
First in Man Clinical Study to Evaluate Safety and Tolerability of an Oncolytic Adenovirus in Prostate Cancer Patients.
This open label, dose escalating study is a phase I/IIa first in man study designed to evaluate the safety and tolerability of intratumoral administration of a novel oncolytic adenovirus (ORCA-010) in treating diagnosed treatment…
- Trial name
- NCT04097002
- Testing
- ORCA-010
- Where
- 5 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Orca Therapeutics B.V.
Mantle Cell Lymphoma (MCL)
Orelabrutinib Combined With Obinutuzumab and Short-Course Venetoclax in Patients With Treatment-Naïve Mantle Cell Lymphoma (MCL)
This study aims to evaluate the safety and efficacy of orelabrutinib (O) in combination with obinutuzumab (G) and short-course venetoclax (V) in patients with treatment-naïve MCL.
- Trial name
- NCT07719556
- Testing
- Orelabrutinib, Obinutuzumab, Venetoclax
- Where
- 2 sites in China
- Volunteers
- 39 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Diabetes Mellitus Type 2
A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes mellitus who are drug-naïve to…
- Trial name
- NCT01871428
- Testing
- aleglitazar
- Where
- 7 sites in China, Hong Kong and 1 more
- Volunteers
- 13 people
- Sponsor
- Hoffmann-La Roche
Type 2 Diabetes Mellitus
Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus
Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The long-acting insulin has showed to improve glycemic variability however the behavior of insulin glargine versus insulin degludec is unknown.
- Trial name
- Diabetes (NCT02680457)
- Testing
- Insulin Degludec, Insulin Glargine
- Where
- Mexico
- Volunteers
- 12 people
- Sponsor
- University of Guadalajara
Hepatitis C
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT).
- Trial name
- NCT01054729
- Testing
- Sofosbuvir, PEG, RBV
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 64 people
- Sponsor
- Gilead Sciences
Follicular Lymphoma
Study of Lenalidomide, Venetoclax and Obinutuzumab in Patients With Treatment-Naïve Follicular Lymphoma
The trial will investigate the combination of venetoclax, obinutuzumab and lenalidomide in patients with treatment-naïve follicular lymphoma.
- Trial name
- LEVERAGE (NCT03980171)
- Testing
- Obinutuzumab, Venetoclax, Lenalidomide
- Where
- 3 sites in Australia
- Volunteers
- 50 people
- Sponsor
- Peter MacCallum Cancer Centre, Australia
Marginal Zone Lymphoma (MZL)
Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.
This study aims to explore a new treatment approach for patients with treatment-naive Marginal Zone Lymphoma (MZL). MZL is a type of slow-growing lymphoma that often affects older adults.
- Trial name
- NCT07372365
- Testing
- Orelabrutinib Consolidation and Maintenance Therapy
- Where
- China
- Volunteers
- 23 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Systemic Lupus Erythematosus
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without…
- Trial name
- SUNFLOWER (NCT07430306)
- Testing
- Anifrolumab
- Where
- 107 sites in United States, Canada and 7 more
- Volunteers
- 245 people
- Sponsor
- AstraZeneca
Primary Immunodeficiency Diseases (PID)
A Study of TAK-664 in People With Primary Immunodeficiency Diseases Who Have Not Yet Been Treated With Immunoglobulins
Primary immunodeficiency disease (or PIDD) is a group of conditions in which the immune system does not work properly. Some people with PIDD do not make enough antibodies.
- Trial name
- NCT07794735
- Testing
- TAK-664
- Volunteers
- 9 people
- Sponsor
- Takeda
Type 1 Diabetes
Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy
Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (MDI) Group".
- Trial name
- STAR3 (NCT00417989)
- Testing
- MiniMed Paradigm REAL-Time System
- Where
- 30 sites in United States, Canada
- Volunteers
- 485 people
- Sponsor
- Medtronic MiniMed, Inc.
Chronic Hepatitis C Virus
VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
- Trial name
- NCT01581138
- Testing
- VX-222, telaprevir, ribavirin
- Where
- 18 sites in United States
- Volunteers
- 64 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Major Depressive Disorder
Repetitive Transcranial Magnetic Stimulation in Pharmaco-naïve Patients With Major Depression
Repetitive transcranial magnetic stimulation (rTMS) has become a safe and efficacious treatment for patients with treatment-resistant depression.
- Trial name
- NAIV (NCT04000022)
- Testing
- intermittent theta burst stimulation (iTBS)
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- University Hospital, Bonn
Chronic Hepatitis C, CHC
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C, CHC, HCV, Hepatitis C
- Trial name
- NCT01842451
- Testing
- VX-135, Daclatasvir
- Where
- 2 sites in New Zealand
- Volunteers
- 23 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Glycogen Storage Disease Type II;Pompe's Disease
Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease
Primary Objective: To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa.
- Trial name
- COMET (NCT02782741)
- Testing
- Avalglucosidase alfa (GZ402666), Alglucosidase alfa (GZ419829)
- Where
- 69 sites in United States, Argentina and 23 more
- Volunteers
- 101 people
- Sponsor
- Genzyme, a Sanofi Company
Waldenstrom Macroglobulinemia, MYD88 Gene Mutation
Ibrutinib + Venetoclax in Untreated WM
This study evaluates the safety and efficacy of Ibrutinib combined with Venetoclax (IVEN) in the treatment of adults diagnosed with Waldenstrom's macroglobulinemia (WM) cancer with a specific MYD88 gene mutation.
- Trial name
- NCT04273139
- Testing
- IBRUTINIB, Venetoclax
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- Dana-Farber Cancer Institute
Non-Hodgkin Lymphoma
Comparing Interleukin-2 (IL-2) Combined With Rituximab (Rituxan) to Rituximab Alone in Subjects With Non-Hodgkin's Lymphoma (NHL)
The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8 weeks in combination with rituximab is effective and safe when compared to rituximab given alone in the treatment of follicular NHL…
- Trial name
- NCT00100737
- Testing
- interleukin-2, rituximab
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Chiron Corporation