Luis A. Balart, MD

Hepititis C Clinical Trials: Active 2007

1. PEG-Intron plus Rebetol for the Treatment of Subjects with Chronic Hepatitis C who failed to Respond to Previous Combination Therapy (any alpha interferon treatment in combination with ribavirin) (Protocol PO2370)

1. PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects with Compensated Cirrhosis, Secondary to Chronic Hepatitis C, who have Failed to Respond to Therapy with any Alpha Interferon plus Ribavirin (Protocol PO2569)

1. PEG-Intron Maintenance Therapy vs. an Untreated Control Group for Prevention of Progression of Fibrosis in Adult Subjects with Chronic Hepatitis C with Hepatic Fibrosis (METAVIR Fibrosis Score of F2 or F3), who failed therapy with PEG-Intron plus Rebetol (in Protocol PO2370) (Protocol PO2570)

1. Comparison of PEG-Intron 1.5 mcg/kg/wk plus Rebetol vs PEG-Intron 1mcg/kg/wk plus Rebetol vs PEGASYS 180 mcg/wk plus COPEGUS in previously Untreated Adult Subjects with Chronic Hepatitis C Infected with Genotype 1 (Protocol PO3471).

1. Randomized, Multicenter, Double-Blinded, Phase IV Study Evaluating the Efficacy and Safety of360mcg Induction Dosing of Pegasys in Combination with Higher Copegus Doses in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection Of High Viral Titer and Baseline Body Weight Greater than or Equal to 85kg (Protocol NV18210)

1. A Safety and Efficacy Study of SCH503034 in Preciously Untreated Subjects with Chronic Hepatitis C Infected with Genotype 1 (Protocol P03523)

1. Long-Term Follow-Up of Subjects in a Phase 2 or 3 Clinical Trial in which SCH503034 was Administered for the Treatment of Chronic Hepatitis C (Protocol P05063)

1. An Observational Study of Frequent and Early Depression Screening During HCV Therapy with Interferon (Protocol LRI-03839-03)

1. CPG 10101 Combination Therapy for the Treatment of Hepatitis C: A Phase II Trial of CPG 10101 at Two Different Dose Levels with Pegylated Interferon Alpha 2B (PEG-IFN) Plus Ribavirin (RVN) or PEG-IFN Plus RVN Without CPG 10101 in the Treatment of Non-Responders (Null and Partial Responders) HCV Genotype 1 Infected Subjects (Protocol CPG10101-004)

1. A Phase 2, Randomized, Open-Label Study of the Safety, Antiviral Activity, and Pharmacokinetics of HCV-796 Administered in Combination with Peginterferon Alfa 2B (Peg-Intron) Plus Ribavirin (Rebetol) Versus Peg-Intron Plus Rebetol in Subjects with Hepatitis C Virus Genotype 1 Infection (Protocol 3173A1-200-US)