Hepatitis C
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CLINICAL_TRIALS research · 2015-03-23Clinical Trial Update: Qualification of Point-of-Care Assays for Management of HCV Patients
Update on a clinical trial evaluating point-of-care diagnostic assays for managing Hepatitis C patients.
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FDA approval · 2015-03-20FDA Approved: LEDIPASVIR AND SOFOSBUVIR — Supplemental Application (Asegua Therapeutics LLC)
The FDA approved a supplemental application for Ledipasvir and Sofosbuvir (Harvoni) submitted by Asegua Therapeutics LLC.
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FDA approval · 2015-03-20FDA Approved: SOVALDI — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for Sovaldi (sofosbuvir) submitted by Gilead Sciences, Inc.
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CLINICAL_TRIALS trial_result · 2015-03-20Clinical Trial Update: Q-Trial in Patients With Hepatitis C [Phase 1]
An update on a Phase 1 clinical trial (Q-Trial) for chronic hepatitis C, noting that the study has completed.
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CLINICAL_TRIALS trial_result · 2015-03-20Clinical Trial Update: Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV) [Phase 2]
Phase 2 trial update evaluating intrahepatic HCV RNA and pharmacokinetics of telaprevir in Hepatitis C. Results have been posted.
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CLINICAL_TRIALS trial_result · 2015-03-20Clinical Trial Update: Hepatitis C Treatment of Inmates [Phase 4]
Phase 4 clinical trial evaluating hepatitis C treatment in inmates has been terminated.
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CLINICAL_TRIALS trial_result · 2015-03-17Clinical Trial Update: A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV) [Phase 3]
Phase 3 study evaluating telaprevir with ribavirin and peginterferon for HIV/Hepatitis C coinfection was terminated, with results posted in …
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CLINICAL_TRIALS trial_result · 2015-03-11Clinical Trial Update: Effect of Teleprevir in Triple Therapy on Intrahepatic Immunological Mechanisms
A completed clinical trial evaluated telaprevir-based triple therapy (telaprevir + pegylated interferon + ribavirin) and its impact on intra…
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CLINICAL_TRIALS research · 2015-03-09Clinical Trial Update: Score System for Prediction Risk and Early Diagnosis of HCC in HIV/HCV Patients
This clinical trial update describes a scoring system to predict risk and enable early diagnosis of hepatocellular carcinoma in patients co-…
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CLINICAL_TRIALS trial_result · 2015-03-09Clinical Trial Update: Hepatitis C Virus (HCV) Treatment Completion or Withdrawal
The document reports the completion or withdrawal of a Hepatitis C treatment study (NCT00674492); results were posted in 2015.
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CLINICAL_TRIALS withdrawal · 2015-03-09Clinical Trial Update: Effect of a Change in HIV Therapy on Liver Steatosis, Inflammation, and Fibrosis [NA]
This clinical trial evaluated the impact of changing HIV therapy on liver steatosis, inflammation, and fibrosis in individuals with HIV and …
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CLINICAL_TRIALS trial_result · 2015-03-06Clinical Trial Update: Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1 [Phase 2]
An open-label Phase 2 safety study evaluating the combination of telaprevir and sofosbuvir in adults with chronic hepatitis C genotype 1; re…
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CLINICAL_TRIALS trial_result · 2015-03-06Clinical Trial Update: Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC) [Phase 3]
Phase 3 trial update of telaprevir with standard of care in hepatitis C virus-associated hepatocellular carcinoma has been terminated; resul…
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CLINICAL_TRIALS trial_result · 2015-03-05Clinical Trial Update: THISTLE - The HIV-HCV Silibinin Trial [Phase 2]
Update on a Phase 2 HIV and Hepatitis C trial evaluating silibinin (THISTLE) conducted by University of Zurich. The trial has completed.
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CLINICAL_TRIALS withdrawal · 2015-03-05Clinical Trial Update: Randomized Study for the Assessment of Silibinin (Legalon® SIL) in the Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C [Phase 2, Phase 3]
A Phase 2/3 randomized study evaluating silibinin (Legalon SIL) in treatment-naive genotype 4 chronic hepatitis C patients has been withdraw…
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CLINICAL_TRIALS trial_result · 2015-03-05Clinical Trial Update: Effect of LEGALON SIL on Hepatitis C Virus Recurrence in Stable Liver Transplanted Patients [Phase 2]
Phase 2 trial evaluating LEGALON SIL for preventing Hepatitis C recurrence in stable liver transplant recipients was terminated.
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CLINICAL_TRIALS trial_result · 2015-02-24Clinical Trial Update: A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir [Phase 1]
This document reports a Phase 1 bioequivalence study of daclatasvir tablets and bioavailability studies of daclatasvir and asunaprevir. The …
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CLINICAL_TRIALS trial_result · 2015-02-23Clinical Trial Update: Japanese Phase II Study of SB-497115-GR in Hepatitis C Virus Infected Patients [Phase 2]
Phase II Japanese study of SB-497115-GR in chronic hepatitis C has completed and results have been posted.
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CLINICAL_TRIALS trial_result · 2015-02-11Clinical Trial Update: Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype [Phase 3]
Phase 3 trial evaluating a 12-week regimen of telaprevir with pegylated interferon and ribavirin in treatment-naive and prior relapser chron…
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CLINICAL_TRIALS trial_result · 2015-02-10Clinical Trial Update: Study of Drug Combination on Pharmacokinetics in Healthy Volunteers [Phase 1]
A Phase 1 study evaluating the pharmacokinetics of a drug combination in healthy volunteers for hepatitis C has completed.
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CLINICAL_TRIALS trial_result · 2015-02-09Clinical Trial Update: Safety, Tolerability, PK and PD of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With HCV Genotype 1 (Protocol No. P04695) [Phase 1]
Phase 1 study evaluating safety, tolerability, PK and PD of SCH 900518 in adults with chronic hepatitis C (genotype 1) has completed.
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CLINICAL_TRIALS trial_result · 2015-02-06Clinical Trial Update: Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005) [Phase 2]
Phase 2 trial results evaluate the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin over 12 we…
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CLINICAL_TRIALS trial_result · 2015-02-05Clinical Trial Update: Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003) [Phase 1]
This update reports safety, pharmacokinetics, and pharmacodynamics data from Phase 1 testing of MK-6325 in hepatitis C virus infections. The…
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CLINICAL_TRIALS trial_result · 2015-02-04Clinical Trial Update: Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants [Phase 2]
Phase 2 trial assessing 12 weeks of Sovaprevir, ACH-3102, and Ribavirin in treatment-naive genotype-1 hepatitis C patients; study completed …
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CLINICAL_TRIALS trial_result · 2015-02-04Clinical Trial Update: Safety and Efficacy of PegIntron and Rebetol Combination Therapy in Patients With Chronic Hepatitis C in Japan (Study P04505)
A completed Japanese study assessing the safety and efficacy of PegIntron (pegylated interferon alfa-2b) plus Rebetol (ribavirin) in chronic…