Clinical trials: Treatment naïve
Hepatitis C Virus
A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV…
- Trial name
- Navigator (NCT01458535)
- Testing
- ABT-450, ABT-267, ribavirin
- Volunteers
- 61 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Diabetic Macular Edema
A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.
- Trial name
- GLEAM (NCT04611152)
- Testing
- KSI-301, Aflibercept
- Where
- 75 sites in United States, Germany and 6 more
- Volunteers
- 460 people
- Sponsor
- Kodiak Sciences Inc
Diabetes Mellitus Type 2
A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy
This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not…
- Trial name
- NCT01691755
- Testing
- aleglitazar
- Where
- 34 sites in United States, Mexico
- Volunteers
- 196 people
- Sponsor
- Hoffmann-La Roche
Colorectal Carcinoma
Safety and Efficacy Study of mFOLFOX6 + Panitumumab Combination Therapy and 5-FU/LV + Panitumumab Combination Therapy in Participants With Chemotherapy-naïve Unresectable Advanced Recurrent Colorectal Carcinoma
The purpose of this study is to exploratorily examine efficacy and safety in the participants with chemotherapy-naïve unresectable, advanced/recurrent colorectal carcinoma of Kirsten rat sarcoma-2 virus (KRAS) wild-type who have…
- Trial name
- SAPPHIRE (NCT02337946)
- Testing
- oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab
- Where
- 49 sites in Japan
- Volunteers
- 164 people
- Sponsor
- Takeda
HIV Infection, Hepatitis C
A Study Exploring an Induction-Maintenance Kaletra-Based Therapy Versus a Sustiva-Based Regimen in Previously Non-Treated, HIV-1/HCV Co-Infected Subjects
The purpose of this study is to determine whether a simplified lopinavir/ritonavir-based therapy will continue to keep the viral load at very low levels after initial treatment with a combination of Kaletra (lopinavir/ritonavir)…
- Trial name
- NCT00121017
- Testing
- Kaletra (lopinavir/ritonavir), Sustiva (efavirenz), Truvada (emtricitabine/tenofovir disoproxil fumarate)
- Volunteers
- 200 people
- Sponsor
- Abbott
NSCLC
A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
A randomized, double-blind, positive controlled phase III study to evaluate the efficacy and safety of BPI-7711 capsule in locally advanced or recurrent/metastatic treatment-naïve non-small cell lung cancer patients with EGFR…
- Trial name
- NCT03866499
- Testing
- BPI-7711, Gefitinib
- Where
- 3 sites in China
- Volunteers
- 369 people
- Sponsor
- Beta Pharma Shanghai
Hepatitis C Virus (HCV)
Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and…
- Trial name
- PRINCIPAL (NCT01616524)
- Testing
- Pegylated interferon lambda (pegIFNλ), Pegylated interferon alfa-2a (pegIFNα-2a), Ribavirin
- Where
- 124 sites in United States, Argentina and 17 more
- Volunteers
- 880 people
- Sponsor
- Bristol-Myers Squibb
Head and Neck Squamous Cell Carcinoma
A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC).
This biomarker study has been designed to assess the effects of different agents in both tumour tissue and peripheral samples to help inform the best combinations of DDR agents with immuno-oncology (IO) therapies.
- Trial name
- NCT03022409
- Testing
- Ceralasertib, Olaparib
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 21 people
- Sponsor
- AstraZeneca
HIV
Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC
The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48 of a daily regimen of Atazanavir (ATV)/…
- Trial name
- NCT01620944
- Testing
- Atazanavir, Ritonavir, Lamivudine
- Volunteers
- 3 people
- Sponsor
- Bristol-Myers Squibb
HIV, HIV Infections
Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir…
- Trial name
- NCT01797445
- Testing
- E/C/F/TAF, E/C/F/TDF
- Where
- 117 sites in United States, Canada and 9 more
- Volunteers
- 872 people
- Sponsor
- Gilead Sciences
Non-Small Cell Lung Cancer
LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer
A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that…
- Trial name
- NCT01685138
- Testing
- LDK378
- Where
- 51 sites in United States, Australia and 16 more
- Volunteers
- 124 people
- Sponsor
- Novartis Pharmaceuticals
Arthritis, Psoriatic
A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Trial name
- ICONIC-PsA 1 (NCT06878404)
- Testing
- Icotrokinra, Active reference comparator
- Where
- 155 sites in United States, Argentina and 14 more
- Volunteers
- 552 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis C, Chronic
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an…
- Trial name
- NCT00793793
- Testing
- BI201335
- Where
- 16 sites in United States, France and 2 more
- Volunteers
- 96 people
- Sponsor
- Boehringer Ingelheim
Chronic Hepatitis C Infection
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as…
- Trial name
- PEARL-IV (NCT01833533)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin
- Volunteers
- 305 people
- Sponsor
- AbbVie
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
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous…
- Trial name
- NCT02499120
- Testing
- palbociclib, Cetuximab
- Where
- 71 sites in United States, Czechia and 13 more
- Volunteers
- 125 people
- Sponsor
- Pfizer
Leukemia, Chronic Lymphocytic Leukemia
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or…
- Conditions
- Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Trial name
- Captivate (NCT02910583)
- Testing
- ibrutinib, venetoclax
- Where
- 46 sites in United States, Australia and 4 more
- Volunteers
- 323 people
- Sponsor
- Pharmacyclics LLC.
HIV-1 Infection
Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1…
- Trial name
- NCT01309243
- Testing
- FTC/RPV/TDF, EFV/FTC/TDF
- Where
- 151 sites in United States, Australia and 12 more
- Volunteers
- 799 people
- Sponsor
- Gilead Sciences
Infection, Human Immunodeficiency Virus
Phase Ib/IIa Clinical Study of ACC017 Tablets
ACC017 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase Ib/IIa, randomized, double-blind, parallel, dose ranging, placebo-controlled 'proof of concept' study is designed to evaluate…
- Trial name
- NCT06719310
- Testing
- ACC017+FTC/TAF
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.
Hypophosphatasia
Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP
The primary purpose of this study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.
- Trial name
- MULBERRY (NCT06079359)
- Testing
- ALXN1850
- Where
- 32 sites in United States, Australia and 14 more
- Volunteers
- 30 people
- Sponsor
- Alexion Pharmaceuticals, Inc.