Clinical trials: ASV
Hepatitis C
Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and Rosuvastatin
The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin.
- Trial name
- NCT02104843
- Testing
- Daclatasvir, Asunaprevir and BMS-791325 FDC, BMS-791325, Rosuvastatin
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Ventilator Lung
I-ASV in Cardiac Surgery
'POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II) is an investigator-initiated, international, multicenter, parallel, randomized clinical trial in patients after cardiac surgery.
- Trial name
- POSITiVE II (NCT06178510)
- Testing
- INTELLiVENT-ASV.
- Where
- Austria
- Volunteers
- 328 people
- Sponsor
- Medical University of Vienna
Hepatitis C Virus
Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)
The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit…
- Trial name
- Hallmark DUAL (NCT01581203)
- Testing
- Asunaprevir (ASV), Daclatasvir (DCV), Pegylated-interferon alfa 2a (PegIFN)
- Where
- 116 sites in United States, Argentina and 16 more
- Volunteers
- 748 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C
A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection
- Trial name
- NCT00722358
- Testing
- BMS-650032
- Where
- 5 sites in United States, Puerto Rico
- Volunteers
- 15 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet
Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.
- Trial name
- NCT02108639
- Testing
- DCV 3DAA FDC, BMS-791325
- Where
- 4 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Sleep Apnea, Heart Failure
Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure
Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of…
- Trial name
- ADVENT-HF (NCT01128816)
- Testing
- Adaptive Servo Ventilation
- Where
- 49 sites in United States, Brazil and 7 more
- Volunteers
- 732 people
- Sponsor
- Toronto Rehabilitation Institute
Sleep Disorder; Breathing-Related, Heart Failure
Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy (PEP ASV)
This is a prospective, single-arm, unblinded pilot study and registry that aims to demonstrate adherence to adaptive servo-ventilation (ASV) therapy in patients with moderate to severe sleep disordered breathing who have been…
- Trial name
- PEP-ASV (NCT04133350)
- Testing
- Active Patient Engagement
- Where
- 4 sites in United States, Germany
- Volunteers
- 2 people
- Sponsor
- Thomas Jefferson University
Hepatitis C
A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.
- Trial name
- NCT02496078
- Testing
- Daclatasvir, Asunaprevir
- Where
- 29 sites in China, Russia and 1 more
- Volunteers
- 207 people
- Sponsor
- Bristol-Myers Squibb
Heart Failure, Obstructive Sleep Apnea
ASV Effects on Myocardial Energetics and Sympathetic Nerve Function in Heart Failure and Sleep Apnea.
Obstructive sleep apnea (OSA), central sleep apnea (CSA) and heart failure (HF) are states of metabolic demand and sympathetic nervous system (SNS) activation.
- Conditions
- Heart Failure, Obstructive Sleep Apnea, Central Sleep Apnea
- Trial name
- AMEND (NCT02116140)
- Testing
- [C11]Acetate and HED PET
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Hepatitis C
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection
- Trial name
- D-LITE (NCT01795911)
- Testing
- Pegylated Interferon Lambda, Ribasphere, Daclatasvir
- Where
- United States
- Volunteers
- 165 people
- Sponsor
- Bristol-Myers Squibb
Solid Tumor, Adult
Phase 1a Study to Evaluate Immunogenicity of ASV®
This is an open-label Phase 1a First-in-Human Study to determine Safety and Tolerability of ASV® AGEN2017 with QS-21 Stimulon® Adjuvant as a Single Agent in Subjects With Tumors at Risk of Relapse Undergoing Observation as…
- Trial name
- NCT03673020
- Testing
- ASV® AGEN2017 + QS-21 Stimulon® adjuvant
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Agenus Inc.
Acute Decompensated Heart Failure, Sleep Disordered Breathing
Cardiovascular Improvements With MV ASV Therapy in Heart Failure
The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF.
- Trial name
- CAT-HF (NCT01953874)
- Testing
- MV ASV, Optimized Medical Treatment
- Where
- 15 sites in United States, Germany
- Volunteers
- 126 people
- Sponsor
- ResMed
Hepatitis C
UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.
- Trial name
- NCT01973049
- Testing
- Daclatasvir, Asunaprevir, BMS-791325
- Where
- 49 sites in United States, Australia and 2 more
- Volunteers
- 202 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
- Trial name
- NCT03071133
- Where
- Japan
- Volunteers
- 344 people
- Sponsor
- Bristol-Myers Squibb
Acute Exacerbation of COPD
Non Invasive Ventilation With NAVA vs ASV for AECOPD
Non invasive ventilation is the standard of care in managing patients with exacerbation of chronic obstructive pulmonary disease.
- Trial name
- NCT04414891
- Testing
- Non invasive ventilation
- Where
- India
- Volunteers
- 76 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Chronic Hepatitis C
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV…
- Trial name
- NCT02250001
- Where
- Japan
- Volunteers
- 2,974 people
- Sponsor
- Bristol-Myers Squibb
Heart Failure, Sleep Disorder
Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result…
- Conditions
- Heart Failure, Sleep Disorder, Cheyne Stokes Respiration
- Trial name
- MS (NCT01164592)
- Testing
- adaptive servoventilation (ASV)
- Where
- 94 sites in Australia, Czechia and 6 more
- Volunteers
- 312 people
- Sponsor
- ResMed
Central Sleep Apnea, Heart Failure With Preserved Ejection Fraction
Quality of Sleep of Patients With Predominant Central Sleep Apnea Syndrome(SAS) Whose EF > 45% Treated by ASV
The main goal of this French multicenter observational cohort study is to prospectively collect data assessing the impact of the Adaptative Servo-Ventilation treatment on the quality of sleep of patients with central or combined…
- Trial name
- FACIL-VAA (NCT02835638)
- Testing
- Adaptative Servo Ventilation
- Where
- 28 sites in France
- Volunteers
- 520 people
- Sponsor
- Société Française de Recherche et de Médecine du Sommeil
Hepatitis C
Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV
A single-arm, multi-center study of HCV-1b patients without baseline non-structure protein (NS5A) resistance-associated variants.
- Trial name
- NCT03004625
- Testing
- daclatasvir, asunaprevir, Ribavirin
- Where
- Taiwan
- Volunteers
- 70 people
- Sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Hepatitis C
UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
- Trial name
- NCT01979939
- Testing
- DCV/ASV/BMS-791325
- Where
- 66 sites in United States, Australia and 3 more
- Volunteers
- 416 people
- Sponsor
- Bristol-Myers Squibb