Hepatitis C
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CLINICAL_TRIALS research · 2016-02-04Clinical Trial Update: Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing
This trial update describes collection of plasma and serum samples from individuals initiating Sofosbuvir for Hepatitis C to support testing…
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CLINICAL_TRIALS research · 2016-02-02Clinical Trial Update: Use of Direct-acting Antiviral to Treat HCV Recurrence After Liver Transplantation (ANRSCO23CUPILT) Infection
A clinical trial update on using direct-acting antiviral therapy to treat hepatitis C recurrence after liver transplantation (ANRS CO23 CUPI…
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CLINICAL_TRIALS withdrawal · 2016-02-02Clinical Trial Update: 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 [Phase 2]
A Phase 2 trial evaluating a triple therapy of asunaprevir, daclatasvir, and BMS-791325 for hepatitis C genotype 4 after failure of pegylate…
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CLINICAL_TRIALS trial_result · 2016-02-02Clinical Trial Update: A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C. [Phase 4]
Phase 4 trial update evaluating NeoRecormon (epoetin beta) for anemia in patients with hepatitis C; the study has completed.
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CLINICAL_TRIALS trial_result · 2016-02-01Clinical Trial Update: Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection [Phase 2]
Phase 2 trial assessing safety, antiviral activity, and pharmacokinetics of BI 207127 plus BI 201335 with or without ribavirin over 4 to 40 …
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CLINICAL_TRIALS trial_result · 2016-01-29Clinical Trial Update: Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects [Phase 1]
Phase 1 proof-of-concept study evaluating the safety and preliminary efficacy of EDP239 in adults with hepatitis C; the trial has completed.
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CLINICAL_TRIALS research · 2016-01-29Clinical Trial Update: A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C
This document describes a multicenter treatment protocol evaluating the combination of daclatasvir and sofosbuvir in post-liver transplant p…
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FDA approval · 2016-01-28FDA Approved: ZEPATIER — Original Application (Merck Sharp & Dohme LLC)
FDA approved ZEPATIER, a fixed-dose combination of elbasvir and grazoprevir, for the treatment of chronic hepatitis C virus infection in adu…
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CLINICAL_TRIALS withdrawal · 2016-01-27Clinical Trial Update: 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 C
A multicenter compassionate-use program of daclatasvir plus sofosbuvir, with or without ribavirin, for chronic hepatitis C is no longer avai…
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CLINICAL_TRIALS trial_result · 2016-01-26Clinical Trial Update: Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004) [Phase 1]
Phase 1 study evaluating the drug-drug interaction between IDX719 and simeprevir in healthy participants; related to Chronic Hepatitis C Inf…
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CLINICAL_TRIALS trial_result · 2016-01-26Clinical Trial Update: Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008) [Phase 1]
Phase 1 pharmacokinetic study evaluating IDX719 in participants with normal and impaired hepatic function to support dosing considerations i…
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CLINICAL_TRIALS trial_result · 2016-01-26Clinical Trial Update: A Open-label Study to Evaluate the Relative Bioavailability of Samatasvir (IDX184) and Food Effect in Healthy Male Participants (MK-2355-006) [Phase 1]
This clinical trial update reports the completion of a Phase 1 open-label study to compare the relative bioavailability of Samatasvir (IDX18…
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CLINICAL_TRIALS trial_result · 2016-01-26Clinical Trial Update: Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007) [Phase 1]
Phase 1 study evaluating potential drug-drug interactions among IDX719, simeprevir, TMC647055, and ritonavir in healthy participants.
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CLINICAL_TRIALS trial_result · 2016-01-26Clinical Trial Update: Safety Study of Recombinant Interferon Variant(PEG-IFN-SA) to Treat HCV Disease [Phase 1, Phase 2]
The document reports completion of a Phase 1/2 safety study evaluating a pegylated interferon variant (PEG-IFN-SA) for hepatitis C infection…
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CLINICAL_TRIALS trial_result · 2016-01-26Clinical Trial Update: Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects [Phase 1]
Phase 1 clinical trial update for IDX21459 assessing single and multiple doses in healthy and Hepatitis C-infected subjects; the study statu…
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CLINICAL_TRIALS trial_result · 2016-01-22Clinical Trial Update: To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006) [Phase 1]
Phase 1 pharmacokinetic study evaluating whether ritonavir or omeprazole affects exposure to samatasvir (IDX719) in healthy participants; th…
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CLINICAL_TRIALS trial_result · 2016-01-22Clinical Trial Update: A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002) [Phase 1]
A Phase 1 study evaluated the potential drug-drug interaction between IDX320 and IDX184 in healthy participants, related to chronic hepatiti…
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CLINICAL_TRIALS trial_result · 2016-01-21Clinical Trial Update: ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection. [Phase 4]
Phase 4 study evaluating Pegasys (peginterferon alfa-2a) in combination with COPEGUS (ribavirin) in interferon-naive patients with chronic h…
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CLINICAL_TRIALS trial_result · 2016-01-20Clinical Trial Update: A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C [Phase 4]
A Phase 4 clinical trial update reports results for ribavirin in combination with Pegasys (pegylated interferon alfa-2a) in patients with ch…
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CLINICAL_TRIALS withdrawal · 2016-01-20Clinical Trial Update: 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) [Phase 2]
The Phase 2b trial evaluating the fixed-dose combination of daclatasvir and sofosbuvir for non-cirrhotic, treatment-naive hepatitis C patien…
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CLINICAL_TRIALS trial_result · 2016-01-18Clinical Trial Update: Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection
A completed clinical trial comparing two triple regimens for treatment and retreatment of chronic Hepatitis C infection.
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CLINICAL_TRIALS trial_result · 2016-01-15Clinical Trial Update: SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study [Phase 2]
Phase II clinical trial update showing results for SHO-SAIKO-TO in chronic hepatitis C; the study has completed and results were posted in 2…
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CLINICAL_TRIALS withdrawal · 2016-01-15Clinical Trial Update: 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 3 [Phase 2]
Phase 2 randomized, open-label study of daclatasvir and sofosbuvir with or without ribavirin for 8 weeks in treatment-naïve, non-cirrhotic h…
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CLINICAL_TRIALS trial_result · 2016-01-14Clinical Trial Update: REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy [Phase 4]
Phase 4 study evaluating peginterferon alfa-2a (40 kDa) plus ribavirin in chronic hepatitis C patients who did not respond to prior peginter…
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CLINICAL_TRIALS trial_result · 2016-01-11Clinical Trial Update: A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Patients Infected With Chronic Genotype 1 Hepatitis C Virus [Phase 2]
Phase 2 study evaluating a 12-week combination therapy of TMC647055 and TMC435 with and without GSK23336805, plus a pharmacokinetic enhancer…