Phase 3 N=64 Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial
Chronic Hepatitis C
Primary: The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response. — 11; 10 participants
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Phase 2 N=21 High-Dose Ribavirin and Peginterferon to Treat Chronic Hepatitis C Genotype 1
Chronic Hepatitis C
Primary: Sustained Virological Response, (HCV RNA Neg.) in Serum 24 Weeks Off Therapy. — 3 participants
Phase 3 N=703 A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection
Chronic Hepatitis C · Hepatitis C Virus · HCV
Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting…
Phase 3 N=36 A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection
Chronic Hepatitis C Virus (HCV) Infection
Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment — 100 percentage of participants
Phase 3 N=305 A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
Chronic Hepatitis C Infection
Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses — 97.0; 90.2 percentage of participants
Phase 3 N=650 ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
Hepatitis C Virus (HCV)
Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 99.5; 100 percentage of participants
Phase 2 N=580 ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients
Chronic Hepatitis C · Hepatitis C (HCV) · Hepatitis C Genotype 1
Primary: Number of Participants With Adverse Events (AEs) — 67; 36; 71; 68 participants
Phase 3 N=18 Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease
Hepatitis C Virus (HCV)
Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 100; 80.0 percentage of participants
Phase 3 N=105 Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection
Hepatitis C Virus (HCV)
Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 89.5 percentage of participants
Phase 2 N=116 A Study of TMC435350 Administered With or Without Standard of Care Therapy in Participants With Genotype 1 Hepatitis C Virus Infection
Hepatitis C, Chronic
Primary: Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and…
Phase 4 N=200 Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO
Hepatitis C, Chronic
Primary: Sustained Virological Response (SVR) at Week 12 — 116; 66 Participants
Phase 3 N=79 A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection
Hepatitis C, Chronic
Primary: The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12) — 91.7; 100.0; 38.5 Percentage of Participants
Phase 3 N=419 A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection
Chronic Hepatitis C Infection
Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate — 99.5…
Phase 2 N=332 Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
Hepatitis C, Chronic
Primary: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) — 90.4; 92.7; 91.0; 93.3 percentage of participants…
Phase 2 N=72 Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816
Chronic Hepatitis C
Primary: Number of Participants With Sustained Virologic Response — 70 Participants
Phase 3 N=25 Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
Chronic Hepatitis C · Hepatitis C (HCV) · Hepatitis C Genotype 1a
Primary: Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12 — -0.464; -0.148; -0.611…
Phase 3 N=152 Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
Hepatitis C
Primary: Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) — 90.1…
Phase 2 N=147 Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients
Hepatitis C Virus
Primary: Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period — 97.9; 97.9; 100.0; 96.0 percentage of participants
Phase 3 N=166 A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
Hepatitis C Infection · Hepatitis C Virus
Primary: Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 97.6 percentage of participants
Phase 3 N=328 Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
Chronic Hepatitis C
Primary: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 — 91 percentage of participants — p=< 0.001
Phase 3 N=159 Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)
Hepatitis C
Primary: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) — 93.5; 91.8 Percentage of participants
Phase 2 N=46 Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
Chronic Hepatitis C · Hepatitis C (HCV) · Hepatitis C Genotype 1a
Primary: Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment — 0.0036; 0.0046; 0.0051 1/day — p=0.311
Phase 2 N=168 Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus
Hepatitis C Virus
Primary: Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12) — 84.9; 69.6; 74.5; 95 Percentage of participants
Phase 3 N=394 An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients
Hepatitis C
Primary: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) — 79.5; 50 Percentage of participants…
Phase 2 N=30 A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects
Chronic Hepatitis C
Primary: Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants — -2.13; -3.31; -2.91; -2.58 log10 IU/mL
Phase 3 N=636 A Study to Evaluate Chronic Hepatitis C Infection
Chronic Hepatitis C Infection
Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment — 96.4 percentage of participants
N/A N=538 Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)
Hepatitis C, Chronic
Primary: Number of Study Participants Who Had a Virological Response (VR) at Week-72 — 176 Participants
Phase 3 N=391 An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants
Hepatitis C
Primary: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) — 81.3; 50.0 Percentage of participants…
Phase 3 N=275 A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
Chronic Hepatitis C · Human Immunodeficiency Virus
Primary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) — 89.5; 84.8; 84.0; 90.9 percentage of participants
Phase 3 N=68 Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
Chronic Hepatitis C · Hepatitis C Virus · Compensated Cirrhosis
Primary: Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment — 94.1 percentage of participants