Clinical trials: Treatment naïve
Infection, Human Immunodeficiency Virus, HIV Infections
A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)
This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine…
- Trial name
- NCT01910402
- Testing
- Dolutegravir/abacavir/lamivudine FDC, Atazanavir, Ritonavir
- Where
- 90 sites in United States, Argentina and 11 more
- Volunteers
- 499 people
- Sponsor
- ViiV Healthcare
HIV, HIV Infections
Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir…
- Trial name
- NCT01780506
- Testing
- E/C/F/TAF, E/C/F/TDF
- Where
- 117 sites in United States, Australia and 10 more
- Volunteers
- 872 people
- Sponsor
- Gilead Sciences
Hypercholesterolemia
Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects
The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese…
- Trial name
- NCT02055976
- Testing
- Bococizumab (PF-04950615;RN316), Ezetimibe
- Where
- 9 sites in Japan
- Volunteers
- 218 people
- Sponsor
- Pfizer
Lymphocytic Leukemia, Chronic
CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy.
- Trial name
- NCT02013817
- Testing
- rituximab [MabThera/Rituxan], fludarabine, cyclophosphamide
- Where
- 8 sites in Austria
- Volunteers
- 43 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus, Type 2
Lantus Versus Levemir Treat-To-Target
Primary objective: To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not…
- Trial name
- L2T3 (NCT00405418)
- Testing
- Insulin glargine, Insulin Detemir
- Where
- 20 sites in Australia, Brazil and 18 more
- Volunteers
- 973 people
- Sponsor
- Sanofi
Hepatitis C Virus
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than…
- Trial name
- HEPCAT (NCT01125189)
- Testing
- Daclatasvir, peg-interferon alfa-2a, ribavirin
- Where
- 64 sites in United States, Australia and 9 more
- Volunteers
- 558 people
- Sponsor
- Bristol-Myers Squibb
Ovarian Cancer
FLABRA: Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study
This study aims to answer very important questions regarding the prevalence of somatic and germline mutations (sBRCAm and gBRCAm) in a population of newly diagnosed ovarian cancer patients from Latin America.
- Trial name
- FLABRA (NCT02984423)
- Where
- 27 sites in Argentina, Brazil and 4 more
- Volunteers
- 471 people
- Sponsor
- AstraZeneca
Diabetic Macular Edema
A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab
This is an exploratory, prospective, multicenter, open-label, single-arm, interventional, Phase IIb study designed to explore the associations over time between clinical assessments, multimodal imaging assessments, aqueous humor…
- Trial name
- ALTIMETER (NCT04597918)
- Testing
- Faricimab
- Where
- 23 sites in United States, Argentina and 5 more
- Volunteers
- 99 people
- Sponsor
- Hoffmann-La Roche
Wet Age-related Macular Degeneration
Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients
The purpose of this observational study lies in the analysis of a treat-and-extend injection scheme with intravitreal aflibercept (i.e.
- Trial name
- ASTERIA (NCT03382587)
- Testing
- Aflibercept (Eylea, BAY86-5321)
- Where
- Switzerland
- Volunteers
- 163 people
- Sponsor
- Bayer
Chronic Hepatics C Virus (HCV) Genotype 1, Non-Cirrhotic
To Evaluate Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in HCV Genotype I Infected Patients
A phase II study to evaluate the efficacy and safety in TG-2349 combination with DAG181 (± Ribavirin) in treatment naïve subjects with chronic hepatic C virus genotype I infection.
- Conditions
- Chronic Hepatics C Virus (HCV) Genotype 1, Non-Cirrhotic, Cirrhosis, Treatment naïve
- Trial name
- NCT03593447
- Testing
- non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin, non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin, non-cirrhotic subjects. low TG-2349+ low DAG181
- Where
- China
- Volunteers
- 133 people
- Sponsor
- Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
Colorectal Cancer
An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer
The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable…
- Trial name
- NCT02394834
- Testing
- oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab, oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab
- Where
- 151 sites in Japan
- Volunteers
- 757 people
- Sponsor
- Takeda
Paroxysmal Nocturnal Hemoglobinuria (PNH)
ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).
- Trial name
- NCT02946463
- Testing
- Ravulizumab, Eculizumab
- Where
- 120 sites in United States, Argentina and 24 more
- Volunteers
- 272 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Gastric Cancer
A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy…
- Trial name
- NCT06256328
- Testing
- ONO-4578, Oxaliplatin, Capecitabine
- Where
- 63 sites in Japan, South Korea and 1 more
- Volunteers
- 226 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Mucopolysaccharidosis (MPS), Hunter Syndrome
A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)
The main aim of this study is to evaluate the ability of a prophylactic immune tolerizing regimen (ITR) to prevent or reduce the development of high titer anti-idursulfase antibodies in treatment-naïve participants with Hunter…
- Trial name
- NCT05494593
- Testing
- ELAPRASE, Rituximab, Methotrexate
- Where
- 8 sites in United States
- Sponsor
- Takeda
Gastric Cancer, Gastroesophageal Junction Cancer
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer
- Trial name
- MAHOGANY (NCT04082364)
- Testing
- margetuximab, Retifanlimab, Tebotelimab
- Where
- 73 sites in United States, China and 7 more
- Volunteers
- 82 people
- Sponsor
- MacroGenics
Non-Hodgkin's Lymphoma
A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas
This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera.
- Trial name
- NCT01153971
- Testing
- rituximab
- Where
- 15 sites in Italy
- Volunteers
- 47 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C Infection
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects…
- Trial name
- GIFT I (NCT02023099)
- Testing
- ABT-450/r/ABT-267
- Volunteers
- 363 people
- Sponsor
- AbbVie
Fabry Disease
Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease
Primary Objective: To assess the long-term safety of GZ/SAR402671 in adult male participants with Fabry disease who previously completed study ACT13739 (NCT02489344).
- Trial name
- NCT02489344
- Testing
- GZ/SAR402671
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 8 people
- Sponsor
- Genzyme, a Sanofi Company
Acute Myeloid Leukemia (AML), Cancer
A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
A study evaluating the effectiveness and safety of venetoclax, in combination with azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML who are ineligible for intensive chemotherapy.
- Trial name
- NCT03941964
- Testing
- Venetoclax, Azacitidine, Decitabine
- Where
- 16 sites in United States
- Volunteers
- 60 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus…
- Trial name
- NCT02413593
- Testing
- LDV/SOF, RBV
- Where
- 15 sites in Canada
- Volunteers
- 111 people
- Sponsor
- Gilead Sciences