Clinical trials: Treatment naïve
HCV Infection
Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care [SOC]) compared to placebo + SOC.
- Trial name
- NCT00978497
- Testing
- ANA598, Peginterferon, Ribavirin
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 97 people
- Sponsor
- Hoffmann-La Roche
HIV Infections, Hepatitis B
Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection
This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).
- Trial name
- NCT00127959
- Testing
- tenofovir, emtricitabine, zidovudine
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- International Antiviral Therapy Evaluation Center
Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC.
- Conditions
- Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT04752722
- Testing
- EG-70 (phase 1), EG-70 (phase 2) Master Protocol, Surfactant Bladder Pre-Rinse and EG-70 (Substudy)
- Where
- 102 sites in United States, Australia and 8 more
- Volunteers
- 350 people
- Sponsor
- enGene, Inc.
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in…
- Trial name
- NCT07266831
- Testing
- ISL, ULO, BIC/FTC/TAF
- Where
- 55 sites in United States, Argentina and 7 more
- Volunteers
- 570 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C, Hepatitis C (HCV)
Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin…
- Conditions
- Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1a
- Trial name
- NCT02493855
- Testing
- Ombitasvir/ABT-450/Ritonavir, Dasabuvir, Ribavirin (RBV)
- Volunteers
- 46 people
- Sponsor
- AbbVie
Primary Biliary Cholangitis (PBC)
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
The goal of this clinical trial is to learn if the drug Fenofibrate works to treat adults with a liver disease called Primary Biliary Cholangitis (PBC) who have not received previous treatment.
- Trial name
- NCT07296458
- Testing
- Fenofibrate, UDCA (Ursodeoxycholic acid)
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Small Cell Lung Cancer
Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body.
- Trial name
- NCT04624204
- Testing
- Pembrolizumab 200 mg, Pembrolizumab 400 mg, Olaparib 300 mg BID
- Where
- 187 sites in United States, Australia and 23 more
- Volunteers
- 672 people
- Sponsor
- Merck Sharp & Dohme LLC
Hiv
Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART
To evaluate the effect of early viral reactivation by latency reversing agents (LRA) and/or administration of potent broadly neutralizing antibodies (bNAb) on the size of the latent HIV-1 reservoir in treatment naïve HIV-1…
- Trial name
- eCLEAR (NCT03041012)
- Testing
- Romidepsin, 3BNC117, Antiretrovirals
- Where
- 7 sites in Denmark, United Kingdom
- Volunteers
- 60 people
- Sponsor
- Aarhus University Hospital
Glioblastoma, Gliosarcoma
ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme
This phase II clinical trial studies how well ERC1671 plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) plus Cyclophosphamide with Bevacizumab works compared to Placebo Injection plus Placebo Pill with Bevacizumab in…
- Trial name
- NCT01903330
- Testing
- ERC1671, GM-CSF, Cyclophosphamide
- Where
- 3 sites in United States
- Volunteers
- 84 people
- Sponsor
- Epitopoietic Research Corporation
Spinal Muscular Atrophy
A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years With Spinal Muscular Atrophy (SMA) Who Are Either New to SMA Treatment or Were Previously Treated With Risdiplam
In this study, researchers will learn more about the effects and safety of BIIB115, also known as salanersen. Specifically, researchers will learn more about how salanersen works in individuals with SMA who are between the ages…
- Trial name
- SOLAR (NCT07444476)
- Testing
- Salanersen
- Where
- 3 sites in United States, China
- Volunteers
- 90 people
- Sponsor
- Biogen
Hepatitis C, Chronic
Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection.
- Trial name
- NCT00774397
- Testing
- BI 201335 NA 240 mg QD / LI, PegIFN/RBV, BI 201335 NA 120mg QD / LI
- Where
- 100 sites in United States, Argentina and 13 more
- Volunteers
- 719 people
- Sponsor
- Boehringer Ingelheim
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
Hepatitis C, HIV
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics…
- Trial name
- NCT01565889
- Testing
- SOF, EFV/FTC/TDF, EFV
- Where
- Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF)
Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages.
- Conditions
- Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)
- Trial name
- NCT04878003
- Testing
- KRT-232, TL-895
- Where
- 29 sites in United States, Belarus and 7 more
- Volunteers
- 52 people
- Sponsor
- Kartos Therapeutics, Inc.
HIV-1
Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)
To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI).
- Trial name
- DRIVE-FORWARD (NCT02275780)
- Testing
- Doravirine, Darunavir, Ritonavir
- Volunteers
- 769 people
- Sponsor
- Merck Sharp & Dohme LLC
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
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
Arthritis, Psoriatic
Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422)
This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.
- Trial name
- NCT00367237
- Testing
- Infliximab + methotrexate (IFX + MTX), Methotrexate (MTX)
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis B
Residual Histological Disease Across Treatment Pathways in Chronic Hepatitis B
This retrospective, two-center observational study evaluates contemporary non-biopsy treatment pathways in treatment-naïve adults with chronic hepatitis B who underwent liver biopsy in routine clinical practice.
- Trial name
- CHB-PATH (NCT07843446)
- Where
- Turkey (Türkiye)
- Volunteers
- 1,201 people
- Sponsor
- Istanbul Medeniyet University
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