32 completed, 2 unknown, 2 withdrawn. 13 Phase 2, 10 Phase 3, 9 Phase 1, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Completed 12, Withdrawn 1 |
| Phase 3 | 10 | Completed 10 |
| Phase 1 | 9 | Completed 9 |
| Phase 4 | 2 | Completed 1, Withdrawn 1 |
Follow asunaprevir: new trials by email Literature Review of asunaprevir trials Research Report on asunaprevir
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effectiveness and Safety of Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C Direct-acting antiviral agents - Hepatitis C, Chronic | Unknown | Qing XIe | 300 | 2019-03-06 | 2021-07-07 | |
| Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV daclatasvir, asunaprevir, Ribavirin - Hepatitis C | Phase 3 | Completed | Kaohsiung Medical University Chung-Ho Memorial Hospital | 70 | 2016-11-01 | 2019-01-09 |
| Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment Daclatasvir and Asunaprevir - Chronic Hepatitis C | Unknown | Sang Gyune Kim | 103 | 2016-09-01 | 2017-03-07 | |
| The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure Daclatasvir plus Asunaprevir - Hepatitis C | Phase 4 | Completed | Myeong Jun Song | 21 | 2016-02-01 | 2018-07-18 |
| A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection Daclatasvir, Asunaprevir - Hepatitis C | Phase 3 | Completed | Bristol-Myers Squibb | 207 | 2015-08-01 | 2017-04-19 |
| Impact of HCV Treatment on Neurocognitive Functions and Brain Metabolism DCV/ASV/BCV - Hepatitis C, Chronic | Phase 4 | Withdrawn | Kirby Institute | 2015-07-01 | 2016-06-03 | |
| Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects LDV/SOF+ASV, SOF+DCV+SMV, SOF+DCV+ASV - Chronic Hepatitis C Infection | Phase 2 | Completed | Humanity and Health Research Centre | 18 | 2015-01-01 | 2016-03-01 |
| A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir Daclatasvir, Asunaprevir - Hepatitis C Infection | Phase 1 | Completed | Bristol-Myers Squibb | 88 | 2014-12-01 | 2015-02-24 |
| Pilot Study to Assess Efficacy and Safety of a Triple Therapy With Asunaprevir, Daclatasvir, and BMS-791325 in HCV Genotype 4-infected Patients After Failure of Pegylated Interferon-Ribavirin Regimen .Asunaprevir, Daclatasvir and BMS - 791325 - Hepatitis C Virus Genotype 4 Infection | Phase 2 | Withdrawn | ANRS, Emerging Infectious Diseases | 2014-12-01 | 2016-02-02 | |
| UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C Daclatasvir, Asunaprevir, DCV 3DAA - Hepatitis C Virus Infection | Phase 3 | Completed | Bristol-Myers Squibb | 297 | 2014-04-01 | 2015-09-18 |
| Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and Rosuvastatin Daclatasvir, Asunaprevir and BMS-791325 FDC, BMS-791325, Rosuvastatin - Hepatitis C | Phase 1 | Completed | Bristol-Myers Squibb | 18 | 2014-04-01 | 2014-07-18 |
| 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 DCV 3DAA FDC, BMS-791325 - Hepatitis C | Phase 1 | Completed | Bristol-Myers Squibb | 41 | 2014-04-01 | 2014-07-10 |
| Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325 FDC of Daclatasvir, Asunaprevir and BMS-791325, FDC of Norethindrone and Ethinyl Estradiol, BMS-791325 - Hepatitis C | Phase 1 | Completed | Bristol-Myers Squibb | 20 | 2014-04-01 | 2014-08-15 |
| Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual Asunaprevir, Daclatasvir - Hepatitis C | Phase 3 | Completed | Bristol-Myers Squibb | 218 | 2014-02-28 | 2020-08-11 |
| Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients Daclatasvir, asunaprevir - Chronic Hepatitis C | Phase 3 | Completed | Foundation for Liver Research | 12 | 2014-02-01 | 2015-10-19 |
| Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV Asunaprevir and Daclatasvir, Asunaprevir and Daclatasvir with BMS-791325 - HIV-HCV | Phase 2 | Completed | National Institutes of Health Clinical Center (CC) | 30 | 2014-02-01 | 2017-05-16 |
| 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 Daclatasvir, Asunaprevir, BMS-791325 - Hepatitis C | Phase 3 | Completed | Bristol-Myers Squibb | 202 | 2013-12-01 | 2015-10-09 |
| Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO) Asunaprevir, Daclatasvir, Ribavirin - Hepatitis C Virus Genotype 4 Infection | Phase 2 | Completed | ANRS, Emerging Infectious Diseases | 60 | 2013-11-01 | 2026-04-13 |
| Pilot Study to Assess the Efficacy of and Tolerance to a QUadruple Therapy to Treat HIV-HCV Coinfected Patients Previously Null Responders Asunaprevir, Daclatasvir, Ribavirin and Peginterferon alfa-2a - HCV-HIV Co-Infection | Phase 2 | Completed | ANRS, Emerging Infectious Diseases | 75 | 2012-12-01 | 2014-09-08 |
| Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease Asunaprevir - Hepatitis C | Phase 1 | Completed | Bristol-Myers Squibb | 48 | 2012-11-01 | 2013-11-11 |
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Hepatitis C (24) · Hepatitis C, Chronic (8) · Coinfection (1) · Fibrosis (1) · Hepatic Insufficiency (1) · Hepatitis (1)
Bristol-Myers Squibb (25) · ANRS, Emerging Infectious Diseases (3) · Foundation for Liver Research (1) · Humanity and Health Research Centre (1) · Kaohsiung Medical University Chung-Ho Memorial Hospital (1) · Kirby Institute (1) · Myeong Jun Song (1) · National Institutes of Health Clinical Center (CC) (1) · Qing XIe (1) · Sang Gyune Kim (1)
United States (17) · France (12) · South Korea (8) · Australia (6) · Germany (6) · Italy (6) · Japan (6) · Spain (6) · Taiwan (6) · Argentina (5) · Canada (5) · Puerto Rico (5) · China (4) · Ireland (4) · United Kingdom (4)
Dominique Roulot, MD (1) · George Lau, MD (1) · Gregory Dore, BSc, MBBS, FRACP, MPH, PhD (1) · Henry Masur, M.D. (1) · Lionel Piroth, MD PhD (1) · Ming-Lung Yu, MD., PhD. (1) · Qing Xie, MD (1) · Rebecca N Wood-Horrall, MD (1) · Rob de Knegt, M.D. (1) · Sang Gyune Kim, Professor (1)
PMID 26683763, PMID 22256805, PMID 23178977, PMID 23183526, PMID 23504694, PMID 24184132, PMID 24604476, PMID 24704773, PMID 25038486, PMID 25078304, PMID 25703086, PMID 25942724, PMID 25977266, PMID 26223768, PMID 26473667, PMID 27009831, PMID 27287851, PMID 27917405, PMID 28941023, PMID 29271782, PMID 30400729, PMID 34996920
2009 (1), 2014 (1)