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Clinicaltrialforweb9 17 08

Division of Gastroenterology and Hepatology
Currently Enrolling HCV Clinical Trials
Research study contact: 646-962- HepC (4372)
Description
Key Information
A Phase 1b Randomized Placebo-Control ed Clinical Trial to Study the Safety Genotype 1, Treatment Naïve, Stage < 2, males age 18-55, study and Efficacy of MK-7009 in Hepatitis C Infected Patients period 22 days with study drug/placebo for 7 days, compensation provided. Novartis
A randomized, double-blind, placebo-control ed, multicenter, time-lagged, Phase I, Genotype 1, Treatment relapser, Stage < 3, age 18-69 paral el, multiple-dose, escalating dose study to assess safety/tolerability, males and females with non child bearing potential, study period is pharmacokinetic and pharmacodynamic profiles fol owing administration of 14 days of study drug/placebo with pegylated interferon with the NIM811(cyclosporin analogs) in patients with viral hepatitis C genotype 1 option to continue on pegylated interferon and ribavirin for up to 48 weeks, compensation provided. Intarcia
Phase Ib Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics Genotype 1, Relapsers to previous pegylated interferon and and Antiviral Activity of Omega DUROS® (Implantable device to deliver ribavirin, compensated cirrhosis al owed, age 18-65 males and Omega Interferon) and Ribavirin in Subjects with Chronic Hepatitis C Previously Treated with Pegylated Interferon and Ribavirin Phase II, Randomized, Double-Blind, Placebo-Controlled Study Of Genotype 1, Treatment Naïve, male/female age ≥18, BMI < 34, no Nitazoxanide In Combination With Peginterferon a-2a And Ribavirin In diabetes, Randomized to receive study drug/placebo with Treatment-Naïve Patients With Hepatitis C Pegasys and Copegus for study period of 48 weeks. Compensation provided. Schering
A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Genotype 1, Relapsers or partial responders (no nul responders), Hepatitis C Genotype 1 Who Failed Prior Treatment With male/female age ≥18, must have had at least 12 weeks of Pegylated Interferon and Ribavirin, must have had ≥ 2 log ↓ in HCV RNA by treatment week 12 or detectable HCV RNA after end of treatment. 20% chance of placebo, can rol over to active treatment at TW12 if not responding, treatment period 36-48 weeks, Methadone program patients okay. Schering
Boceprevir in Previously Untreated Subjects with Chronic Hepatitis C Infected Genotype 1, Treatment Naïve (never received any treatment for with Genotype 1. A Phase 3 Safety and Efficacy Study (P05216) HCV), males/females age ≥18, 20% chance of placebo, can Rol over to active treatment at TW24 if not responding. Treatment period 28-48 weeks, Methadone program patients okay. Division of Gastroenterology and Hepatology
Currently Enrolling HBV Clinical Trials
Research study contact: 646-962- HepC (4372)
Description
Key Information
Pharmasset
A Multi-center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III HBeAG positive, persistent ALT elevation, HBV DNA > 100,000 Trial of the Efficacy and Safety of Clevudine Compared with Adefovir at Weeks copies/mL , Naive with no prior Nucleoside treatment, age ≥ 16, 48 and 96 in Nucleoside Treatment-Naive Patients with HBeAg Positive Chronic Hepatitis due to Hepatitis B Virus Pharmasset
A Multi-center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III HBeAG negative, persistent ALT elevation, HBV DNA > 100,000 Trial of the Efficacy and Safety of Clevudine Compared with Adefovir at Weeks copies/mL , Naive with no prior Nucleoside treatment, age ≥ 16, 48 and 96 in Nucleoside Treatment-Naive Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus

Source: http://www.hepccenter.org/assets/file/clinicaltrialforweb91708.pdf

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