Hepatitis C
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EMA guidance · 2014-02-21European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C
EMA advises on compassionate use of a new combination therapy for chronic hepatitis C, outlining recommendations for access and use in compa…
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CLINICAL_TRIALS trial_result · 2014-02-19Clinical Trial Update: Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients [Phase 2]
Phase 2 dose-ranging trial evaluating sofosbuvir in combination with pegylated interferon and ribavirin in treatment-naïve genotype 1 hepati…
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CLINICAL_TRIALS trial_result · 2014-02-19Clinical Trial Update: Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients [Phase 2]
Phase 2 trial evaluating sofosbuvir with pegylated interferon and ribavirin in treatment-naive hepatitis C patients has completed and result…
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CLINICAL_TRIALS trial_result · 2014-02-17Clinical Trial Update: Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon [Phase 3]
Phase 3 trial evaluating 12 weeks of sofosbuvir plus ribavirin in adults with chronic hepatitis C genotype 2 or 3 who are interferon intoler…
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CLINICAL_TRIALS trial_result · 2014-02-17Clinical Trial Update: Study to Examine Multiple Doses of TMC647055 in Combination With Telaprevir [Phase 1]
Phase 1 trial update evaluating multiple doses of TMC647055 in combination with telaprevir for Hepatitis C has completed.
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CLINICAL_TRIALS trial_result · 2014-02-17Clinical Trial Update: A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients [Phase 1]
A Phase 1 study of PF-00868554 in hepatitis C virus–positive patients has completed, with results posted in 2014.
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CLINICAL_TRIALS trial_result · 2014-02-11Clinical Trial Update: Virological Response Study of the HCV Vaccine IC41 [Phase 2]
Phase 2 study evaluating the HCV vaccine IC41 in chronic hepatitis C has completed.
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CLINICAL_TRIALS trial_result · 2014-02-11Clinical Trial Update: Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection [Phase 2]
This Phase 2 trial evaluated oral antiviral regimens that include GS-5885 (ledipasvir), Tegobuvir, and/or GS-9451, in combination with pegin…
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CLINICAL_TRIALS research · 2014-02-07Clinical Trial Update: Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)
An observational clinical trial update studying the association between B-cell non-Hodgkin lymphomas and hepatitis C virus infection, sponso…
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CLINICAL_TRIALS research · 2014-02-07Clinical Trial Update: Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A) [Phase 1, Phase 2]
This entry outlines a Phase 1/Phase 2 safety, tolerability, and pharmacokinetic study of recombinant human interferon alfa-2b in patients wi…
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CLINICAL_TRIALS trial_result · 2014-02-06Clinical Trial Update: A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment [Phase 2]
A Phase 2 safety and effectiveness study of TMC435 in chronic genotype 1 hepatitis C patients who failed prior standard treatment has comple…
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CLINICAL_TRIALS trial_result · 2014-02-06Clinical Trial Update: A Study of TMC435350 Administered With or Without Standard of Care Therapy in Participants With Genotype 1 Hepatitis C Virus Infection [Phase 2]
Phase 2 study evaluating TMC435350 with or without standard of care in genotype 1 chronic hepatitis C; results from the trial have been post…
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CLINICAL_TRIALS trial_result · 2014-02-06Clinical Trial Update: Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection [Phase 2]
A Phase 2 safety study evaluating regimens of Sofosbuvir, GS-0938, and Ribavirin in patients with chronic hepatitis C infection has complete…
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CLINICAL_TRIALS trial_result · 2014-02-06Clinical Trial Update: A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C [Phase 2]
Phase 2 study evaluating response-guided duration of combination therapy with GS-9451, Pegasys (peginterferon alfa-2a) and Copegus (ribaviri…
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CLINICAL_TRIALS trial_result · 2014-02-04Clinical Trial Update: A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy [Phase 3]
A Phase 3 trial evaluating TMC435 in genotype 1 hepatitis C patients who relapsed after interferon-based therapy has completed, with results…
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CLINICAL_TRIALS trial_result · 2014-02-04Clinical Trial Update: Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection [Phase 2]
Phase 2 study of GS-9450 for chronic hepatitis C virus infection has been terminated; the update notes status but does not provide efficacy …
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CLINICAL_TRIALS trial_result · 2014-02-03Clinical Trial Update: GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus [Phase 2]
Phase 2 clinical trial update evaluating GS-5885 (ledipasvir) alone or with GS-9451 in combination with peginterferon alfa-2a and ribavirin …
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CLINICAL_TRIALS trial_result · 2014-02-03Clinical Trial Update: GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype [Phase 2]
Phase 2 study of GS-5885 (ledipasvir) and GS-9451 in combination with peginterferon alfa-2a and ribavirin for treatment-naïve chronic genoty…
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CLINICAL_TRIALS research · 2014-01-29Clinical Trial Update: Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c [Phase 3]
A Phase 3 trial is evaluating Vitamin D as an add-on to pegylated interferon and ribavirin for chronic hepatitis C; the trial status is unkn…
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CLINICAL_TRIALS trial_result · 2014-01-28Clinical Trial Update: A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C [Phase 2]
A Phase 2 trial evaluating a response-guided duration strategy for a four-drug regimen (GS-9190, GS-9256, pegylated interferon alfa-2a, and …
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CLINICAL_TRIALS trial_result · 2014-01-27Clinical Trial Update: Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects [Phase 2]
Pfizer's Phase 2 trial of filibuvir in treatment-naive hepatitis C virus genotype 1 subjects has completed and results were posted.
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CLINICAL_TRIALS trial_result · 2014-01-24Clinical Trial Update: A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy [Phase 3]
Phase III trial results for TMC435 in genotype 1 chronic hepatitis C patients who did not respond to prior IFN-based therapy have been compl…
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CLINICAL_TRIALS withdrawal · 2014-01-23Clinical Trial Update: Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients [Phase 3]
A Phase 3 open-label trial comparing BI 207127 to telaprevir for chronic hepatitis C has been withdrawn.
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CLINICAL_TRIALS trial_result · 2014-01-20Clinical Trial Update: A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection [Phase 3]
Phase 3 trial of TMC435 for genotype 1 Hepatitis C has completed enrollment. Results have been posted.
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CLINICAL_TRIALS trial_result · 2014-01-20Clinical Trial Update: A Pilot Study Evaluating Safety of Sitagliptin Combined With Peg-IFN Alfa-2a + Ribavirin in Chronic Hepatitis C Patients [Phase 1]
A Phase 1 pilot trial assessing the safety of combining sitagliptin with pegylated interferon alfa-2a and ribavirin in chronic hepatitis C; …