Clinical trials: Treatment naïve
Carcinoma, Small Cell
A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer
The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment…
- Trial name
- NCT00359359
- Testing
- Sagopilone (BAY86-5302, ZK 219477), Cisplatin
- Where
- 10 sites in Germany
- Volunteers
- 26 people
- Sponsor
- Bayer
Hepatitis C, Chronic
A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) 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 a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®)…
- Trial name
- NCT01271790
- Testing
- Tegobuvir (GS-9190), GS-9451, Pegasys®
- Where
- 144 sites in United States, Austria and 6 more
- Volunteers
- 245 people
- Sponsor
- Gilead Sciences
Hepatitis C
Safety and Tolerability Study of Clemizole Hydrochloride to Treat Hepatitis C in Subjects Who Are Treatment-Naive
The purpose of this study is to test the hypothesis that clemizole hydrochloride is safe and well tolerated when administered to subjects who are infected with hepatitis C virus and have not yet received treatment.
- Trial name
- CLEAN-1 (NCT00945880)
- Testing
- clemizole hydrochloride
- Volunteers
- 12 people
- Sponsor
- Eiger BioPharmaceuticals
Hepatitis C, Chronic
A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C…
- Trial name
- NCT02993250
- Testing
- AL-335, Odalasvir (ODV), Simeprevir (SMV)
- Where
- 14 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Janssen Pharmaceutical K.K.
Type 1 Diabetes
Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy
Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (MDI) Group".
- Trial name
- STAR3 (NCT00417989)
- Testing
- MiniMed Paradigm REAL-Time System
- Where
- 30 sites in United States, Canada
- Volunteers
- 485 people
- Sponsor
- Medtronic MiniMed, Inc.
Hepatitis C, HCV
A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072
This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072 in hepatitis C virus (HCV), genotype…
- Conditions
- Hepatitis C, HCV, Chronic Hepatitis C Infection, Hepatitis C Genotype 1
- Trial name
- Champion2 (NCT01074008)
- Testing
- ABT-450, ABT-072, ABT-333
- Where
- 26 sites in United States, Puerto Rico
- Volunteers
- 74 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hepatitis C, Chronic
Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients
To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment naive or prior treatment relapse patients with…
- Trial name
- NCT01525628
- Testing
- midazolam, BI 201335, tenofovir
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 72 people
- Sponsor
- Boehringer Ingelheim
High-risk Localized Prostate Cancer
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make…
- Trial name
- CHINANEO (NCT07450599)
- Testing
- Darolutamide, ADT
- Where
- 23 sites in China
- Volunteers
- 250 people
- Sponsor
- Bayer
HIV-1 Infection
A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).
The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with and without darunavir/ritonavir 800/100 mg…
- Trial name
- NCT00534352
- Testing
- TMC125; darunavir; ritonavir
- Volunteers
- 23 people
- Sponsor
- Tibotec, Inc
Lung Cancer, Non-squamous, Non-small Cell
Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab
This study is open to adults with a type of lung cancer called HER2-mutant non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread.
- Trial name
- NCT07486817
- Testing
- Zongertinib, Cisplatin, Carboplatin
- Where
- 17 sites in Australia, China and 5 more
- Volunteers
- 60 people
- Sponsor
- Boehringer Ingelheim
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.
Follicular Lymphoma
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study to evaluate the efficacy and safety of ibrutinib in combination with rituximab versus placebo in combination with rituximab in treatment naïve…
- Trial name
- NCT02947347
- Testing
- Ibrutinib Oral Capsule, Rituximab
- Where
- 128 sites in United States, Australia and 17 more
- Volunteers
- 445 people
- Sponsor
- Pharmacyclics LLC.
Hepatitis C, Chronic
A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects with Chronic Hepatitis C Virus…
- Trial name
- NCT01316237
- Testing
- GS-6620, GS-6620 tablet, 450 mg BID, GS-6620 tablet
- Where
- 13 sites in United States, Puerto Rico
- Volunteers
- 90 people
- Sponsor
- Gilead Sciences
Primary Immunodeficiency Disease (PIDD)
Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting
The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients using infusion nurse and patient measured…
- Trial name
- NCT02176239
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- BriovaRx Infusion Services
Chronic HCV Infection
Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection
This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with…
- Trial name
- NCT01975675
- Testing
- LDV/SOF, RBV
- Where
- 19 sites in Japan
- Volunteers
- 341 people
- Sponsor
- Gilead Sciences
Breast Cancer
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer.
- Trial name
- NCT00121836
- Testing
- Capecitabine, Bevacizumab
- Where
- 57 sites in United States
- Volunteers
- 109 people
- Sponsor
- Hoffmann-La Roche
Treatment-naïve, Peripheral T Cell Lymphoma
Liposomal Mitoxantrone Hydrochloride Injection,Cyclophosphamide, Vincristine and Prednisone in the Treatment of PTCL
This is a multicentre, open-label, single-arm, phase Ib clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine…
- Trial name
- NCT04548700
- Testing
- Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone, Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone
- Where
- China
- Volunteers
- 38 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Non-muscle Invasive Bladder Cancer
A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients
A multi-center, randomized, open-label, parallel-controlled Phase Ⅲ clinical trial to evaluate the clinical safety and efficacy of APL-1202 as a single-agent oral treatment versus intravesical instillation of Epirubicin…
- Trial name
- ASCERTAIN (NCT04736394)
- Testing
- APL-1202, Epirubicin Hydrochloride
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Choroidal Neovascularization, Macular Degeneration
Prospective Observational Study to Assess Effectiveness of Intravitreal Aflibercept in Patients With Wet Macular Degeneration in Greece
This is a prospective, observational, multi-center, study. The study will be conducted in approximately 12 ophthalmological clinics and practices throughout Greece.
- Trial name
- PERSEUS-GR (NCT02821247)
- Testing
- Aflibercept (Eylea, BAY86-5321)
- Where
- Greece
- Volunteers
- 119 people
- Sponsor
- Bayer
Macular Degeneration
Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration
Part A (Phase IIa): Primary objectives: The study part A is designed to investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4…
- Trial name
- DREAM (NCT02222207)
- Testing
- Regorafenib, ophthalmic oily suspension (BAY73-4506), Ranibizumab
- Where
- 149 sites in United States, Australia and 16 more
- Volunteers
- 52 people
- Sponsor
- Bayer