Clinical trials: Treatment naïve
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
Hepatitis C
A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.
- Trial name
- NCT02032888
- Testing
- Daclatasvir, Sofosbuvir
- Where
- 37 sites in United States
- Volunteers
- 238 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C(CHC)
Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)
This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.
- Trial name
- NCT01753570
- Testing
- MP-424, RBV(24 weeks), IFN beta(24 weeks)
- Where
- Japan
- Volunteers
- 74 people
- Sponsor
- Tanabe Pharma Corporation
Pompe Disease (Infantile-Onset), Glycogen Storage Disease Type II (GSD II)
A Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease
A study to demonstrate comparable safety, efficacy, and pharmacokinetics (PK) of alglucosidase alfa manufactured at the 160 litre (L) and 4000 L scales in participants who had been diagnosed with infantile-onset Pompe disease.
- Conditions
- Pompe Disease (Infantile-Onset), Glycogen Storage Disease Type II (GSD II), Glycogenosis 2, Acid Maltase Deficiency
- Trial name
- NCT01597596
- Testing
- alglucosidase alfa
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 4 people
- Sponsor
- Genzyme, a Sanofi Company
Hepatitis C, Chronic
Evaluate the Efficacy and Safety of TG-2349 in Subjects With Hepatitis C Infection
A Phase 2, Multicenter, Randomized, Open-label, Dose-ranging Study to Evaluate the Efficacy and Safety of TG-2349 in Combination with Peg-interferon and Ribavirin in Treatment Naïve East Asian Subjects with Chronic Hepatitis C…
- Trial name
- NCT02340962
- Testing
- TG-2349, Ribavirin, Interferon Alfa-2a
- Where
- Taiwan
- Volunteers
- 25 people
- Sponsor
- TaiGen Biotechnology Co., Ltd.
Neovacular Age-related Macular Degeneration
UNcovering the Difference Between Ranibizumab and Aflibercept, Focusing on Systemic Anti-vascular Endothelial Growth Factor (VEGF) Effects in Patients With neovascuLar Age-related Macular Degeneration (AMD)
This study assessed systemic vascular endothelial growth factor (VEGF) level in patients with neovascular Age-related Macular Degeneration following treatment with Ranibizumab or Aflibercept.
- Trial name
- UNRAVEL (NCT01988662)
- Testing
- Neovascular Age-related Macular Degeneration
- Where
- 24 sites in Israel, Malaysia and 5 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Atrial Fibrillation
A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage
The primary purpose of this study is to evaluate the risk of major bleeding and stroke/systemic embolism (SE) among novel oral anti-coagulant (OAC) naïve and warfarin naïve Medicare Advantage patients with non-valvular atrial…
- Trial name
- NCT03189069
- Testing
- Apixaban, Dabigatran, Rivaroxaban
- Volunteers
- 36,000 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C Infection
A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).
- Trial name
- NCT01225380
- Testing
- GS-9190, GS-9256, Pegasys®
- Where
- 114 sites in United States, Austria and 9 more
- Volunteers
- 324 people
- Sponsor
- Gilead Sciences
HIV Infection
Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients
The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard…
- Trial name
- KALEAD (NCT00234910)
- Testing
- Tenofovir DF, lopinavir/ritonavir with 2 Nucleoside RTIs
- Where
- United States
- Volunteers
- 152 people
- Sponsor
- Abbott
Chronic Hepatitis C
Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications
The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment…
- Trial name
- NCT01455090
- Testing
- BMS-650032, BMS-790052, BMS-791325
- Where
- 32 sites in United States, France and 1 more
- Volunteers
- 320 people
- Sponsor
- Bristol-Myers Squibb
HIV
Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment
The purpose of this research study is to compare changes in triglyceride and other lipids (levels of fats found in the blood) from Baseline (Day 1) to Week 12 for darunavir/ritonavir 800/100 mg once daily versus…
- Trial name
- NCT00757783
- Testing
- ritonavir, darunavir, emtricitabine [FTC]/tenofovir [TDF]
- Where
- 15 sites in United States
- Volunteers
- 68 people
- Sponsor
- Tibotec, Inc
Paroxysmal Nocturnal Hemoglobinuria
Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
This is a Phase 3b, single-arm, open-label, multicenter study to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of eculizumab in adult participants with paraxysmal noturnal…
- Trial name
- Soliris (NCT05886244)
- Testing
- Eculizumab
- Where
- 7 sites in China
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatitis C, Chronic
Dose Ranging of GSK2336805 in Combination Therapy
GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being developed for the treatment of chronic HCV infection.
- Trial name
- HAI115879 (NCT01648140)
- Testing
- GSK2336805 40 mg, GSK2336805 60 mg, Pegylated interferon alpha-2a
- Where
- 34 sites in United States, Belgium and 4 more
- Volunteers
- 286 people
- Sponsor
- GlaxoSmithKline
Premenopausal Breast Cancer
A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer
Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with premenopausal breast cancer
- Trial name
- NCT01546649
- Testing
- TAP-144-SR(6M), TAP-144-SR(3M)
- Where
- 15 sites in Japan
- Volunteers
- 167 people
- Sponsor
- Takeda
Metastatic Colorectal Cancer
Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or…
- Trial name
- CodeBreaK 301 (NCT06252649)
- Testing
- FOLFIRI Regimen, Sotorasib, Panitumumab
- Where
- 291 sites in United States, Argentina and 33 more
- Volunteers
- 450 people
- Sponsor
- Amgen
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
HIV-1 Infection
Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)
This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral…
- Trial name
- NCT03272347
- Testing
- Islatravir, Doravirine, Lamivudine
- Where
- 26 sites in United States, Chile and 2 more
- Volunteers
- 123 people
- Sponsor
- Merck Sharp & Dohme LLC
Human Immunodeficiency Virus
Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet
The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients.
- Trial name
- NCT01097655
- Volunteers
- 3,049 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Psoriatic Arthritis (PsA)
Phase 2 Trial of FT2109 for the Treatment of Psoriatic Arthritis
This study will investigate if the study medicine FT2109 can treat symptoms of active Psoriatic Arthritis (PsA). This study assesses the safety and efficacy of FT2109 in adult participants with active PsA who may or may not have…
- Trial name
- NCT07869134
- Testing
- FT2109 Dosing Regimen 1, FT2109 Dosing Regimen 2
- Volunteers
- 210 people
- Sponsor
- Forward Therapeutics
Acute Myeloid Leukaemia
Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.
This is a Phase I/II clinical study to determine the maximum tolerated dose (MTD), and schedule, safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD2811 monotherapy or with combination agent(s) in…
- Trial name
- NCT03217838
- Testing
- AZD2811, Azacitidine, Venetoclax
- Where
- 11 sites in United States, Australia
- Volunteers
- 50 people
- Sponsor
- AstraZeneca