Clinical trials: Treatment naïve
Hepatitis C, Chronic
PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or…
- Trial name
- NCT01066819
- Testing
- Peginterferon alfa-2a [Pegasys], Peginterferon alfa-2b [PegIntron®]
- Where
- 106 sites in United States, Puerto Rico
- Volunteers
- 1,656 people
- Sponsor
- Hoffmann-La Roche
Recurrent Squamous Cell Carcinoma of Head, Recurrent Squamous Cell Carcinoma of Neck
An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1)
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor microenvironment.
- Conditions
- Recurrent Squamous Cell Carcinoma of Head, Recurrent Squamous Cell Carcinoma of Neck, Metastatic Squamous Cell Carcinoma of Head, Metastatic Squamous Cell Carcinoma Neck
- Trial name
- NCT03198130
- Testing
- REGN2810
- Where
- 6 sites in South Korea, United Kingdom
- Volunteers
- 33 people
- Sponsor
- Regeneron Pharmaceuticals
Myelodysplastic Syndromes
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at…
- Trial name
- COMMANDS (NCT03682536)
- Testing
- Luspatercept, Epoetin alfa
- Where
- 226 sites in United States, Australia and 24 more
- Volunteers
- 363 people
- Sponsor
- Celgene
Non-small Cell Lung Cancer
Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no…
- Trial name
- NCT03829332
- Testing
- Pembrolizumab, Lenvatinib
- Where
- 162 sites in United States, Australia and 17 more
- Volunteers
- 623 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and…
- Trial name
- D-LITE (NCT01309932)
- Testing
- Pegylated Interferon Lambda (pegIFNλ), BMS-790052 (NS5A Inhibitor), Ribavirin (RBV)
- Where
- 40 sites in United States, Australia and 7 more
- Volunteers
- 165 people
- Sponsor
- Bristol-Myers Squibb
Diabetes Mellitus, Type 2
Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients
- Trial name
- NCT01708902
- Testing
- linagliptin2.5mg/metformin1000mg, linagliptin 5mg, Metformin 500mg
- Where
- 56 sites in China, Malaysia and 2 more
- Volunteers
- 876 people
- Sponsor
- Boehringer Ingelheim
Macular Edema, Retinal Vein Occlusion
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).
- Trial name
- BEACON (NCT04592419)
- Testing
- KSI-301, Aflibercept
- Where
- 141 sites in United States, Czechia and 10 more
- Volunteers
- 568 people
- Sponsor
- Kodiak Sciences Inc
Multiple Sclerosis, Relapsing-Remitting, Relapsing-Remitting Multiple Sclerosis
Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their…
- Trial name
- IMPROVE (NCT02323269)
- Testing
- dimethyl fumarate
- Where
- 10 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Biogen
Diabetes, Diabetes Mellitus, Type 2
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and…
- Trial name
- NCT00469092
- Testing
- biphasic insulin aspart, insulin glargine, metformin
- Where
- 69 sites in Argentina, Austria and 13 more
- Volunteers
- 480 people
- Sponsor
- Novo Nordisk A/S
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
Hepatitis C Virus (HCV)
A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate…
- Trial name
- EXPEDITION-8 (NCT03089944)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 113 sites in United States, Bulgaria and 17 more
- Volunteers
- 343 people
- Sponsor
- AbbVie
Hepatitis C, Chronic
A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection
This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with…
- Trial name
- NCT00963885
- Testing
- Copegus, Pegasys, RO5190591 (Danoprevir)
- Where
- 43 sites in United States, Australia and 5 more
- Volunteers
- 229 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for…
- Trial name
- POLARIS-2 (NCT02607800)
- Testing
- SOF/VEL/VOX, SOF/VEL
- Where
- 93 sites in United States, Australia and 6 more
- Volunteers
- 943 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection
Primary objectives: The purpose of this study is to determine and compare the sustained virologic response (SVR, undetectable HCV RNA at Follow up week 24 (FW24)) across treatment groups.
- Trial name
- NCT01587586
- Testing
- PEGASYS 180 µg Q1W, P1101 180 µg Q1W, 48 doses, P1101 270µg Q1W, 48 doses
- Where
- 13 sites in Taiwan
- Volunteers
- 107 people
- Sponsor
- PharmaEssentia
Metastatic Melanoma
Study to Determine Efficacy and Safety of CC-486 With Nab-Paclitaxel Versus Nab-Paclitaxel in Patients With Chemotherapy naïve Metastatic Melanoma
A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with Abraxane administered weekly with respect to overall survival, objective tumor response rate and Progression-Free Survival (PFS) in…
- Trial name
- NCT01933061
- Testing
- Abraxane
- Sponsor
- Celgene Corporation
Genotype 1 Chronic Hepatitis C, Treatment Naive
VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1…
- Trial name
- NCT01241760
- Testing
- Ribavirin, Telaprevir, Pegylated interferon alfa-2a
- Where
- 99 sites in United States, Australia and 11 more
- Volunteers
- 744 people
- Sponsor
- Janssen Infectious Diseases BVBA
Localized or Locally Advanced Prostate Cancer
A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve Prostate Cancer
This study is a multi-centre, prospective observational study. The study plans to enrol 500 patients with localized or locally advanced prostate cancer who are eligible and intended to be prescribed Zoladex® (goserelin acetate…
- Trial name
- NCT03193060
- Where
- 25 sites in China
- Volunteers
- 308 people
- Sponsor
- AstraZeneca
Pulmonary Disease, Chronic Obstructive
A Study in the US Based on Pharmacy and Medical Claims That Compares How Well Stiolto® and Trelegy® Work in People With Chronic Obstructive Pulmonary Disease (COPD)
This study looks at data from people with chronic obstructive pulmonary disease (COPD). Some used Stiolto Respimat and the others Trelegy Ellipta as their first treatment for COPD.
- Trial name
- NCT05169424
- Testing
- Trelegy Ellipta, Stiolto Respimat, Tiotropium + Olodaterol (5/5 mcg)
- Where
- United States
- Volunteers
- 9,117 people
- Sponsor
- Boehringer Ingelheim
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
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
This is an open-label extension study of another study protocol, MCS-2-TWN-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for this study.
- Trial name
- MCS-2-TWN-c (NCT01002274)
- Testing
- MCS-2
- Where
- Taiwan
- Volunteers
- 180 people
- Sponsor
- Health Ever Bio-Tech Co., Ltd.