Clinical trials: ASV
Hepatitis C
Drug Interaction & Methadone & Buprenorphine
The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in subjects with the stable dose of Methadone and on…
- Trial name
- NCT02045693
- Testing
- Methadone, DCV 3DAA FDC, BMS-791325
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Insomnia, Sleep-Disordered Breathing
CPAP vs ASV for Insomnia
The study will determine which of two different types of positive airway pressure (PAP therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.
- Trial name
- P2P (NCT02365064)
- Testing
- AirCurve 10 ASV
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- ResMed
Chronic Hepatitis C
A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection
- Trial name
- NCT00559247
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Bristol-Myers Squibb
Advanced Cancer
Safety and Tolerability Study of AutoSynVax™ Vaccine in Subjects With Advanced Cancer
Open-label Phase 1 study of AutoSynVax™ vaccine with QS-21 Stimulon® adjuvant in subjects with advanced cancer
- Trial name
- NCT02992977
- Testing
- AutoSynVax™ vaccine
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Agenus Inc.
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
Hepatitis C
Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual
Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir)…
- Trial name
- NCT01995266
- Testing
- Asunaprevir, Daclatasvir
- Where
- 38 sites in China, South Korea and 1 more
- Volunteers
- 218 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C Infection
A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir
Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets. Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet
- Trial name
- NCT02323594
- Testing
- Daclatasvir, Asunaprevir
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease
The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function
- Trial name
- NCT01886599
- Testing
- Asunaprevir
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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
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
Hepatitis C Virus
Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus…
- Trial name
- NCT01030432
- Testing
- BMS-650032, Peginterferon Alfa-2a, Ribavirin
- Where
- 40 sites in United States, Argentina and 6 more
- Volunteers
- 285 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C Infection
An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject
To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.
- Trial name
- NCT01051414
- Testing
- BMS-790052, BMS-650032
- Where
- 4 sites in Japan
- Volunteers
- 43 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)
The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.
- Trial name
- FOURward (NCT02175966)
- Testing
- DCV/ASV/BMS-791325, Ribavirin, Sofosbuvir
- Where
- 7 sites in United States
- Volunteers
- 35 people
- Sponsor
- Bristol-Myers Squibb
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
Heart Failure With Normal Ejection Fraction, Sleep Apnea
Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study
This study is designed to demonstrate feasibility of study conduct and that acceptable adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently hospitalized HFpEF patients with moderate to severe sleep…
- Trial name
- CAT-PEF (NCT03195660)
- Testing
- ASV Therapy
- Where
- 4 sites in United States, Germany
- Volunteers
- 6 people
- Sponsor
- ResMed
Hepatitis C
A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.
- Trial name
- NCT01497834
- Testing
- BMS-790052 (Daclatasvir), BMS-650032 (Asunaprevir)
- Where
- 24 sites in Japan
- Volunteers
- 224 people
- Sponsor
- Bristol-Myers Squibb
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
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
Hepatitis C
Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults
The primary objective of the study is to determine the number of adverse events (AEs) reported by chronic hepatitis C (CHC) patients receiving at least 1 dose of daclatasvir (DCV) and asunaprevir (ASV) at the 2 sentinel sites and…
- Trial name
- NCT03208322
- Testing
- Non-Interventional
- Where
- 2 sites in Mexico
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
Study to Determine the Potential DDIs When the Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Tablet (FDC) is Coadministered With a Cocktail of Cytochrome P450 (CYP) Probe Substrates and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy Subjects
The primary purpose of this study is to assess the effect of the Daclatasvir/Asunaprevir/BMS-791325 fixed dose combination (FDC) tablet on the pharmacokinetics of the cocktail CYP and transporter probe substrates and to assess…
- Trial name
- NCT02045966
- Testing
- Cocktail, DCV 3DAA FDC, BMS-791325
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb