Clinical trials: Treatment naïve
HIV-1, Human Immunodeficiency Virus 1
MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of MK-8510 monotherapy in anti-retroviral-naïve HIV-1 infected participants.
- Conditions
- HIV-1, Human Immunodeficiency Virus 1, Immunodeficiency Virus Type 1, Human, Human Immunodeficiency Virus Type 1
- Trial name
- NCT05700734
- Testing
- MK-8510
- Sponsor
- Merck Sharp & Dohme LLC
Diffuse Large B Cell Lymphoma (DLBCL)
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell Lymphoma
The purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP regimen versus placebo with R-CHOP in the treatment of treatment-naïve patients with MCD subtype DLBCL.
- Trial name
- BELIEVE-01 (NCT05234684)
- Testing
- Orelabrutinib + R-CHOP
- Where
- 44 sites in China
- Volunteers
- 150 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
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
Non-Small Cell Lung Cancer, Urothelial Cancer
A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF)
This is a Phase 2 study to evaluate the safety and efficacy of avelumab in combination with axitinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior platinum…
- Trial name
- NCT03472560
- Testing
- Avelumab (MSB0010718C), Axitinib (AG-013736)
- Where
- 39 sites in United States, Hungary and 6 more
- Volunteers
- 61 people
- Sponsor
- Pfizer
HIV
Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting
The purpose of this study is to describe long term (> 96 weeks) efficacy and safety of Atazanavir-based regimens in real life setting.
- Trial name
- REMAIN (NCT01236235)
- Where
- 53 sites in Germany, Portugal and 1 more
- Volunteers
- 525 people
- Sponsor
- Bristol-Myers Squibb
HIV-1 Infection
Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve…
- Trial name
- NCT04233879
- Testing
- DOR/ISL, BIC/FTC/TAF
- Where
- 95 sites in United States, Argentina and 11 more
- Volunteers
- 599 people
- Sponsor
- Merck Sharp & Dohme LLC
EGFR-TKI-naïve Patients With NSCLC Harboring EGFR Activating Mutations
A Study of ASP8273 in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor-Naïve Patients With Non-Small Cell Lung Cancer Harboring EGFR Mutations
The purpose of this study is to determine the safety, the antitumor activity and the pharmacokinetics of ASP8273 in EGFR tyrosine kinase inhibitor (EGFR-TKI)-naïve patients with non-small cell lung cancer (NSCLC) harboring EGFR…
- Trial name
- NCT02500927
- Testing
- ASP8273 Capsules, ASP8273 Capsules A
- Where
- 11 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Astellas Pharma Inc
HIV Infections
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection.
- Trial name
- NCT07202546
- Testing
- VH4524184, Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets, Dolutegravir / Lamivudine (DTG/3TC)
- Where
- 123 sites in United States, Argentina and 12 more
- Volunteers
- 186 people
- Sponsor
- ViiV Healthcare
Chronic Hepatitis B
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.
The purpose of this study is to determine the safety and antiviral HBV activity of ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection.
- Trial name
- NCT00037622
- Testing
- ACH-126, 443 (beta-L-Fd4C)
- Volunteers
- 100 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
HIV Infections
Boosted Atazanavir and Truvada Given Once-Daily - BATON Study
To determine the safety and efficacy of a simple, once-daily antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with atazanavir boosted with ritonavir in treatment naive…
- Trial name
- NCT00224445
- Testing
- Truvada, Atazanavir, Ritonavir
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Gilead Sciences
Growth Hormone Deficiency
Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects…
- Trial name
- OraGrowtH210 (NCT04614337)
- Testing
- LUM-201, rhGH Norditropin® pen (34 µg/kg)
- Where
- 43 sites in United States, Australia and 4 more
- Volunteers
- 104 people
- Sponsor
- Lumos Pharma
Prostate Carcinoma Metastatic to the Bone, Castration Resistant Prostate Cancer
A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)
The purpose of this study is to evaluate 18F-sodium fluoride positron-emission tomography / computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response in metastatic bone lesions in patients who…
- Trial name
- NCT02384382
- Testing
- Enzalutamide
- Where
- 5 sites in United States
- Volunteers
- 23 people
- Sponsor
- Pfizer
Chronic Hepatitis C Infection
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV)…
- Trial name
- NCT01260350
- Testing
- SOF, RBV, PEG
- Where
- 2 sites in New Zealand
- Volunteers
- 292 people
- Sponsor
- Gilead Sciences
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
HIV Infections
Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection
This prospective observational study will evaluate predictors of response to Invirase (saquinavir) treatment in treatment-naïve patients with HIV infection. Data will be collected during 48 weeks of treatment.
- Trial name
- NCT01297127
- Where
- 8 sites in Poland
- Volunteers
- 151 people
- Sponsor
- Hoffmann-La Roche
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Trial name
- NCT02337829
- Testing
- Acalabrutinib (Arm A), Acalabrutinib (Arm B)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Acerta Pharma BV
Diabetic Macular Edema
A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated
This study will evaluate the efficacy and safety of OZURDEX in patients with Diabetic Macular Edema when used in a real world setting in Spain and Portugal.
- Trial name
- EYEberia (NCT03953807)
- Testing
- Dexamethasone Intravitreal Implant
- Where
- 26 sites in Portugal, Spain
- Volunteers
- 82 people
- Sponsor
- Allergan
HIV-1 Infection
MK-8583 Single Dose Study in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8583-002)
This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-retroviral therapy (ART) activity of the tenofovir prodrug, MK-8583 monotherapy in ART-naïve, HIV-1 infected participants.
- Trial name
- NCT03552536
- Testing
- MK-8583
- Where
- Germany
- Volunteers
- 5 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma
PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)
This is a multi-center, non-randomized, single-arm, open-label, phase Ib, dose escalation/dose expansion study of PTM-101 when combined with neoadjuvant chemotherapy for the treatment of treatment-naïve subjects with borderline…
- Conditions
- Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma, Pancreatic Cancer
- Trial name
- NCT06673017
- Testing
- PTM-101
- Where
- 9 sites in United States, Australia
- Volunteers
- 26 people
- Sponsor
- PanTher Therapeutics