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=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=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=470 IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1
Hepatitis C, Chronic
Primary: SVR12 Rates With Historical Control — 82.5; 71.6; 72.5; 72.5 Percentage of participants — p=<0.0001
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=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 3 N=10 Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults
Chronic Hepatitis C Virus (HCV Infection Genotype 1)
Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment — 80 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 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 2 N=37 Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Chronic Hepatitis C · Hepatitis C Virus (HCV) Infection
Primary: Percentage of Participants With 4-week Rapid Virologic Response (RVR) — 33.3; 55.6; 70.0; 22.2 percentage of participants — p=0.336
Phase 1 N=75 Multiple Oral Doses of BI 207127 NA in Treatment naïve and Treatment-experienced Hepatitis C Virus (HCV)-Infected Patients
Hepatitis C, Chronic
Primary: Virologic Response (VR) — 14.3; 22.2; 55.6; 88.9 percentage of participants
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=189 Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
Hepatitis C
Primary: The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained…
Phase 3 N=117 Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
Chronic HCV Infection
Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 90; 96.4; 100.0; 93.3 percentage of participants
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 2 N=68 Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
Hepatitis C Virus
Primary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12) — 86.4; 100 Percentage of 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 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=64 Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
Hepatitis C
Primary: Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period — 87.5; 83.3; 86.7; 85.7 percentage of participants
Phase 3 N=183 A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients
Hepatitis C, Chronic
Primary: The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12) — 88.6; 61.7…
Phase 3 N=343 A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Hepatitis C Virus (HCV)
Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants…
Phase 2 N=67 Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection
Hepatitis C, Chronic
Primary: Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin…
Phase 4 N=165 A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C
Hepatitis C, Chronic
Primary: Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) — 81; 70; 75; 88 percentage of participants
Phase 3 N=127 Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
Hepatitis C
Primary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) — 50.0; 76.5; 86.7; 90.3 percentage of participants
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 3 N=1,088 A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
Hepatitis C
Primary: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After…
Phase 3 N=230 Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1
Hepatitis C Virus (HCV)
Primary: Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 100.0 percentage of…
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=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