This is a double-blind, placebo controlled, randomized parallel group study conducted in two stages comparing 4 levels of ribavirin (400, 600, 800 and 1000-1200 mg/day) plus Intron A 3 MU TIW and Intron A MU TIW plus placebo in patients with chronic hepatitis C who have not previously been treated with interferon. The Objectives of this two- stage clinical trial are: Stage1: To characterize the relationship between the dose of ribavirin and change in hemoglobin values from baseline at week 4 of treatment when ribavirin is used in combination with Intron A MU TIW, and to identify the hioghest dose of ribavirin that does not significantly increase the hemolysis (decrease in hemoglobin) over that observed with Intron A alone. To evaluate the HCV kinetics in patients treated with Intron A plus placebo and Intron A plus ribavirin at four different doses. Stage 2: To evaluate the safety and efficacy )as measured by loss of HCV RNA) of Intron A plus the dose of Ribavirin identified in stage I and compare it to Intron A plus placebo and Intron A plus ribavirin 1000-1200 mg/day. All patients in stage 1 and stage 2 will complete 24 weeks of treatment and 24 weeks of follow-up. Safety, tolerance and efficacy will be evaluated at weeks 2, 4, 8, 12, 16, and 24 during treatment and 4, 12 and 24 weeks following the end of the therapy. The primary efficacy parameter for his study is the loss of serum HCV-RNA/qPCR 24 weeks following the end of therapy. In addition, the overall response based on loss of HCV-RNA and histologic improvement 24 weeks following the end of therapy will be assessed.
| Lieberman, Jay L; DE Souza, Mary Jane; Wagstaff, David A et al. (2018) Menstrual Disruption with Exercise Is Not Linked to an Energy Availability Threshold. Med Sci Sports Exerc 50:551-561 |
| Zhang, Lijun; Wang, Ming; Sterling, Nicholas W et al. (2018) Cortical Thinning and Cognitive Impairment in Parkinson's Disease without Dementia. IEEE/ACM Trans Comput Biol Bioinform 15:570-580 |
| Rossi, Alexander; Berger, Kristin; Chen, Honglei et al. (2018) Projection of the prevalence of Parkinson's disease in the coming decades: Revisited. Mov Disord 33:156-159 |
| Lee, Soomi; Martire, Lynn M; Damaske, Sarah A et al. (2018) Covariation in couples' nightly sleep and gender differences. Sleep Health 4:201-208 |
| Almeida, David M; Lee, Soomi; Walter, Kimberly N et al. (2018) The effects of a workplace intervention on employees' cortisol awakening response. Community Work Fam 21:151-167 |
| Liu, Guodong; Sterling, Nicholas W; Kong, Lan et al. (2017) Statins may facilitate Parkinson's disease: Insight gained from a large, national claims database. Mov Disord 32:913-917 |
| Sterling, Nicholas W; Du, Guangwei; Lewis, Mechelle M et al. (2017) Cortical gray and subcortical white matter associations in Parkinson's disease. Neurobiol Aging 49:100-108 |
| Berryman, Claire E; Fleming, Jennifer A; Kris-Etherton, Penny M (2017) Inclusion of Almonds in a Cholesterol-Lowering Diet Improves Plasma HDL Subspecies and Cholesterol Efflux to Serum in Normal-Weight Individuals with Elevated LDL Cholesterol. J Nutr 147:1517-1523 |
| Calhoun, Susan L; Fernandez-Mendoza, Julio; Vgontzas, Alexandros N et al. (2017) Behavioral Profiles Associated with Objective Sleep Duration in Young Children with Insomnia Symptoms. J Abnorm Child Psychol 45:337-344 |
| Berger, Paige K; Hohman, Emily E; Marini, Michele E et al. (2016) Girls' picky eating in childhood is associated with normal weight status from ages 5 to 15 y. Am J Clin Nutr 104:1577-1582 |
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