Bristol-Myers Squibb: Hepatitis C trials

The registry lists 97 Hepatitis C studies with Bristol-Myers Squibb as lead sponsor. 0 are open to participants now and 31 have results posted.

Phase 1 27Phase 2 31Phase 3 27No phase 16(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) InfectionTerminatedNCT03487848Phase 2Results posted
• A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis CCompletedNCT03420768Phase 2Results posted
• A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C InfectionCompletedNCT02673489Phase 3Results posted
• Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated CirrhosisCompletedNCT02319031Phase 3Results posted
• Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)CompletedNCT02175966Phase 2Results posted
• A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1CompletedNCT02170727Phase 3Results posted
• Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy ParticipantsCompletedNCT02159352Phase 1Results posted
• Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCVCompletedNCT02032901Phase 3Results posted
• A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.CompletedNCT02032888Phase 3Results posted
• Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver TransplantCompletedNCT02032875Phase 3Results posted
• Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude DualCompletedNCT01995266Phase 3Results posted
• Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIVTerminatedNCT01866930Phase 3Results posted
• Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal ImpairmentCompletedNCT01830205Phase 1Results posted
• Safety and Efficacy Study in Subjects With Chronic HCV and Underlying HemophiliaCompletedNCT01741545Phase 3Results posted
• Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C VirusCompletedNCT01628692Phase 2Results posted
• Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With TelaprevirCompletedNCT01598090Phase 3Results posted
• Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus InfectionCompletedNCT01492426Phase 3Results posted
• Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV VirusCompletedNCT01471574Phase 3Results posted
• Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis CCompletedNCT01448044Phase 3Results posted
• Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus TrialsCompletedNCT01428063Phase 2Results posted
• BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis CCompletedNCT01389323Phase 3Results posted
• Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of CareCompletedNCT01359644Phase 2Results posted
• Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus InfectionCompletedNCT01257204Phase 2Results posted
• Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior TreatmentCompletedNCT01170962Phase 2Results posted
• Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve PatientsCompletedNCT01125189Phase 2Results posted
• Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)CompletedNCT01017575Phase 2Results posted
• Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese PatientsCompletedNCT01016912Phase 2Results posted
• Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female SubjectsCompletedNCT00983957Phase 1Results posted
• Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)CompletedNCT00874770Phase 2Results posted
• A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected SubjectsCompletedNCT00663208Phase 2Results posted
• A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected SubjectsCompletedNCT00546715Phase 1/2Results posted
• Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC)TerminatedNCT03500562
• Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients Previously Treated With Daclatasvir-Based RegimensCompletedNCT03366610
• Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in AdultsWithdrawnNCT03208322
• A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and QatarCompletedNCT03205618
• Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in AdultsCompletedNCT03181074
• Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio TherapyCompletedNCT03071133
• Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in KoreaCompletedNCT02727933
• A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)WithdrawnNCT02556086Phase 2
• A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3WithdrawnNCT02551861Phase 2
• Effectiveness Of Daclatasvir-Based Regimens In Patients With Chronic Hepatitis C Infection In Europe: Experience From Named Patient Program And From Early Post-Marketing Authorization PeriodCompletedNCT02531269
• A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b InfectionCompletedNCT02496078Phase 3
• Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in TaiwanCompletedNCT02402699
• Comparative Assessment of Utilization of Antiviral Therapies in Hepatitis C and Effectiveness of Daclatasvir-containing Regimens in Real-life Clinical Care in Europe (CMPASS-EU)CompletedNCT02368522
• A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and AsunaprevirCompletedNCT02323594Phase 1
• Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis CCompletedNCT02250001
• Study of Drug Combination on Pharmacokinetics in Healthy VolunteersCompletedNCT02175602Phase 1
• A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis CNo longer availableNCT02161939
• UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis CCompletedNCT02123654Phase 3
• Absolute Bioavailability of BMS-791325CompletedNCT02112110Phase 1
• 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 TabletCompletedNCT02108639Phase 1
• Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and RosuvastatinCompletedNCT02104843Phase 1
• Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325CompletedNCT02103569Phase 1
• EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis CNo longer availableNCT02097966
• Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325CompletedNCT02095860Phase 1
• Study to Determine the Effect of BMS-791325 on the ECG QTcF Interval in Healthy SubjectsCompletedNCT02084953Phase 1
• 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 SubjectsCompletedNCT02045966Phase 1
• Drug Interaction & Methadone & BuprenorphineCompletedNCT02045693Phase 1
• 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 SubjectsCompletedNCT01979939Phase 3
• 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 CirrhosisCompletedNCT01973049Phase 3
• Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney DiseaseCompletedNCT01886599Phase 1
• Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve PatientsWithdrawnNCT01797848Phase 3
• Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With RibavirinCompletedNCT01795911Phase 2
• Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis CCompletedNCT01754974Phase 3
• A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)CompletedNCT01732848
• Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) TherapyCompletedNCT01718158Phase 3
• A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV SubjectsCompletedNCT01718145Phase 3
• Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal DysfunctionCompletedNCT01708889Phase 1
• Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis CWithdrawnNCT01629732Phase 2
• 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 3CompletedNCT01616524Phase 3
• Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)CompletedNCT01581203Phase 3
• Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)CompletedNCT01573351Phase 3
• Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic Hepatitis C Clinical TrialCompletedNCT01525810
• Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected PatientsWithdrawnNCT01525212Phase 1
• A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) PatientsCompletedNCT01497834Phase 3
• Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical TrialCompletedNCT01492504
• Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available MedicationsCompletedNCT01455090Phase 2
• Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis CWithdrawnNCT01447394Phase 3
• Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve SubjectsCompletedNCT01445795Phase 1/2
• Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects: Part A: Safety and Efficacy of INX-08189 With Peg IFN Alfa-2a and Ribavirin. Part B: INX-08189 in Interferon Free Treatment With Daclatasvir and/or RibavirinTerminatedNCT01425970Phase 2
• Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With RibavirinCompletedNCT01309932Phase 2
• Ph IIA Study (SOC +/- NS5B)CompletedNCT01193361Phase 2
• A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype IWithdrawnNCT01142700Phase 2
• Drug Interaction Oral Contraceptive Pill (OCP)CompletedNCT01063023Phase 1
• An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) SubjectCompletedNCT01051414Phase 2
• Study of BMS-650032 With Peginterferon Alfa-2a Plus RibavirinCompletedNCT01030432Phase 2
• Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of CareCompletedNCT01012895Phase 2
• Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus InfectionStatus unknownNCT01001754Phase 2
• Study to Assess the Effect of BMS-791325 on the Pharmacokinetics of Midazolam in Healthy SubjectsCompletedNCT00996879Phase 1
• Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C VirusCompletedNCT00971308Phase 1
• Japanese Bridging Study Conducted in the United StatesWithdrawnNCT00947245Phase 1
• Drug-Drug Interaction Study in Healthy SubjectsCompletedNCT00904059Phase 1
• A Multiple Ascending Dose Study of BMS-650032 in HCV Infected SubjectsCompletedNCT00722358Phase 2
• A Study of MDX-1106 to Treat Patients With Hepatitis C InfectionCompletedNCT00703469Phase 1
• A Single Ascending Dose Study of BMS-791325 in HCV Infected SubjectsCompletedNCT00664625Phase 1/2
• Study of PEG-rIL-29 (or PEG-IFN Lambda) in Subjects With Chronic Hepatitis C Virus InfectionCompletedNCT00565539Phase 1
• A Single Ascending Dose Study of BMS-650032 in HCV Infected SubjectsCompletedNCT00559247Phase 1/2