Clinical trials: Treatment naïve
Hepatitis C, Chronic
The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
Primary Objective: To determine the P1101 pharmacokinetic (PK) profile at the single dose of 400 μg.
- Trial name
- NCT04774107
- Testing
- P1101 + Ribavirin
- Where
- 5 sites in Taiwan
- Volunteers
- 17 people
- Sponsor
- PharmaEssentia
Neovascular Age-Related Macular Degeneration (nAMD), Treatment-naïve
Durability of Three Monthly Loading Doses With Faricimab in Treatment-naïve Neovascular Age-related Macular Degeneration
Neovascular Age-Related Macular Degeneration (nAMD) is a one of the leading causes of irreversible vision loss among the elderly in developed countries.
- Trial name
- NCT06890026
- Testing
- Faricimab Injection [Vabysmo]
- Where
- Denmark
- Volunteers
- 742 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Acute Myelogenous Leukemia
Study of MLN4924 Plus Azacitidine in Treatment-naive Participants With Acute Myelogenous Leukemia (AML) Who Are 60 Years or Older
The purpose of this study is to establish the maximum tolerated dose (MTD), and to assess the safety and tolerability of MLN4924 (pevonedistat) in combination with azacitidine in treatment naive participants with AML who were 60…
- Trial name
- NCT01814826
- Testing
- MLN4924, Azacitidine
- Where
- 8 sites in United States
- Volunteers
- 64 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Merkel Cell Carcinoma
Domatinostat in Combination With Avelumab in Patients With Treatment-naïve Metastatic Merkel Cell Carcinoma (MERKLIN 1)
This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with treatment-naïve metastatic Merkel Cell Carcinoma
- Trial name
- NCT04874831
- Testing
- domatinostat in combination with avelumab
- Sponsor
- 4SC AG
Breast Cancer
A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with estrogen receptor positive/ human epidermal growth factor receptor 2 (ER+/HER2)- localized breast cancer.
- Trial name
- NCT05549505
- Testing
- ARV-471, Anastrozole, Surgical resection of breast tumor
- Where
- 49 sites in United States, Georgia and 2 more
- Volunteers
- 152 people
- Sponsor
- Arvinas Inc.
Chronic Spontaneous Urticaria
Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
Primary Objective: This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab…
- Trial name
- NCT04180488
- Testing
- Dupilumab SAR231893, non sedating H1-antihistamine
- Where
- 98 sites in United States, Argentina and 9 more
- Volunteers
- 397 people
- Sponsor
- Sanofi
Hepatitis C, Chronic
A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve…
- Trial name
- NCT01483742
- Testing
- RO5024048, danoprevir, peginterferon alfa-2a [Pegasys]
- Where
- 27 sites in United States, Australia and 5 more
- Volunteers
- 43 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C Virus
Multicenter Study Evaluating 12 Versus 24 Weeks Therapy With Peginterferon and Ribavirin for Hepatitis C Virus (HCV) Genotype 2 or 3
The primary objective of the study is to demonstrate that the efficacy of peginterferon alfa-2a 40KD combination therapy with ribavirin in interferon naïve patients with chronic hepatitis C virus infection genotype 2 or 3 given…
- Trial name
- NCT00143000
- Testing
- Peginterferon alfa-2a 40KD and Ribavirin
- Where
- Sweden
- Volunteers
- 392 people
- Sponsor
- NORDynamIC Study Group
Diabetes Mellitus, Type 2
A Study of Insulin Peglispro (LY2605541) in Participants With Type 2 Diabetes Mellitus
The main purpose of this study is to compare the efficacy and safety of a new basal insulin, insulin peglispro, to insulin glargine in participants with type 2 diabetes mellitus (T2DM).
- Trial name
- NCT02106364
- Testing
- Insulin Peglispro, Insulin Glargine
- Where
- 10 sites in United States
- Sponsor
- Eli Lilly and Company
Hepatitis C Virus (HCV)
Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with compensated cirrhosis with or without human…
- Trial name
- VOYAGE-2 (NCT03235349)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 34 sites in China, South Korea
- Volunteers
- 160 people
- Sponsor
- AbbVie
Leukemia, Myeloid
A Safety, Tolerability and Preliminary Efficacy Study of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia and Treatment-naïve Participants Not Eligible for Intensive Therapy
CC-90011-AML-002 is a Phase 1/2, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently with Venetoclax and Azacitidine.
- Trial name
- NCT04748848
- Testing
- CC-90011, Venetoclax, Azacitidine
- Where
- 17 sites in United States, Belgium and 2 more
- Volunteers
- 1 people
- Sponsor
- Celgene
HIV-1/HBV Co-Infection
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate…
- Trial name
- Alliance (NCT03547908)
- Testing
- B/F/TAF, DTG, F/TDF
- Where
- 69 sites in United States, China and 12 more
- Volunteers
- 244 people
- Sponsor
- Gilead Sciences
HIV Infections, Severe Immunosuppression
A Clinical Trial to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide as a First-line Treatment in Naïve Patients With HIV-1 Infection With Severe Immunosuppression
Phase IV, open, multicentre and single-arm study. 50 HIV infection naive patients with severe immunosuppression will be recruited to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir…
- Trial name
- GENIS (NCT03693508)
- Testing
- Genvoya®
- Where
- 6 sites in Spain
- Volunteers
- 50 people
- Sponsor
- Fundacion SEIMC-GESIDA
Chronic Hepatitis C, Insulin Resistance
Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance
Chronic hepatitis C virus (HCV) infection is associated with an increased risk for the development of type 2 diabetes and HCV infection itself may promote insulin resistance, irrespective of the severity of liver disease.
- Trial name
- NCT00370617
- Testing
- metformin
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- University of Turin, Italy
Carcinoma, Non-Small-Cell Lung
E GFR TKI and EGF-P TI C Ombination in EGFR mutA nt NSCL C
This is a multicentre, open-label, uncontrolled, Phase Ib clinical study. Patients who give informed consent will be screened for the study, including genotyping of the tumour and baseline characteristics.
- Trial name
- EPICAL (NCT03623750)
- Testing
- EGFR-TK Inhibitor, EGF-PTI, Cyclophosphamide
- Where
- 4 sites in Spain
- Volunteers
- 23 people
- Sponsor
- Instituto Oncológico Dr Rosell
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
Neovascular Age-related Macular Degeneration (nAMD), Wet Age-related Macular Degeneration (AMD)
An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting
The purpose of this research study is to observe the patient's clinical care and how EYLEA® HD is used as a treatment in real-world settings.
- Conditions
- Neovascular Age-related Macular Degeneration (nAMD), Wet Age-related Macular Degeneration (AMD), Diabetic Macular Edema (DME), Visual Impairment
- Trial name
- SPECTRUM-US (NCT06398080)
- Testing
- aflibercept 8 mg
- Sponsor
- Regeneron Pharmaceuticals
Hepatitis C, Chronic
A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C…
- Trial name
- NCT01447420
- Testing
- peginterferon alfa-2a, ribavirin [Copegus]
- Where
- 15 sites in Brazil
- Volunteers
- 129 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before.
- Trial name
- QUEST-1 (NCT01289782)
- Testing
- TMC435, Peginterferon alpha-2a (PegIFN alpha-2a), Ribavirin (RBV)
- Where
- 62 sites in United States, Australia and 10 more
- Volunteers
- 395 people
- Sponsor
- Janssen R&D Ireland
HIV Infections
A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)
The purpose of this Phase 2b study is to evaluate the efficacy and therapeutic window of chronically dosed VH4011499 paired with an integrase strand transfer inhibitor (INSTI).
- Trial name
- CINERGY (NCT07816250)
- Testing
- VH4011499, CAB, DTG/3TC
- Volunteers
- 200 people
- Sponsor
- ViiV Healthcare