PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients
Chronic Hepatitis BThis study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the degree of HBsAg decline.
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for...
Hepatitis CChronicThe purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.
Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections...
Hepatitis CThis is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected participants who will be randomized to receive either MK-6325 or placebo. If the drug is shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected participants who will be randomized to receive either MK-6325 or placebo.
Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection...
Chronic Hepatitis C InfectionThe purpose of this study is to study the effects of valacyclovir on patients who have hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which causes genital herpes. Some persons with genital herpes have sores in their private areas but most persons do not have any symptoms at all. Valacyclovir is a medication which is commonly used to treat or prevent outbreaks of genital herpes. This medication is already approved by the Food and Drug Administration to treat genital herpes. Valacyclovir has not been approved to treat chronic hepatitis C. The study will take 16 weeks. Participants will be assigned to take either the study drug, valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and the persons participating will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 3-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center.
Safety, Antiviral Activity, and Pharmacokinetics of GSK2336805 With Peginterferon and Ribavirin...
Hepatitis CChronicGSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and ribavirin in subjects with chronic hepatitis C (CHC).
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis...
Hepatitis CChronicThis study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response [SVR]) versus risk (safety and resistance).
GS-7977 With Ribavirin for Hepatitis C (SPARE)
Hepatitis CBackground: - GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by blocking the hepatitis C virus from dividing in the body. This medication has been used along with other medications commonly used to treat hepatitis C, such as interferon and ribavirin. When used with interferon and ribavirin, GS-7977 seems to be very effective in eliminating the hepatitis C virus from the body. However, interferon can have serious side effects, so researchers want to see if GS-7977 can work by itself or with only ribavirin. Objectives: - To test the safety and effectiveness of GS-7977 alone or given with ribavirin for hepatitis C infection. Eligibility: - Individuals at least 18 years of age who have hepatitis C with liver disease, and have never received drugs for it. Design: This study will require multiple clinic visits over 18 months. A liver biopsy will be required before the start of the study if participants have not had one within the past 3 years. Participants will be screened with a medical history and physical exam. Participants will have either GS-7977 alone or GS-7977 with ribavirin. GS-7977 is taken by mouth once a day. Ribavirin is taken by mouth in the morning and evening. Participants will have study visits on Days 1, 3, 5, 7, 10, and 14. These visits will involve regular blood tests and symptom monitoring. After the second week, participants will have study visits during Weeks 3, 4, 6, 8, 12, 16, and 20. Blood and urine tests will be given to study virus levels in the body, and symptoms will be discussed. Participants will stop receiving the study drugs at Week 24. Followup clinic visits with blood tests will take place in Weeks 28, 36, 48, 52, 60, and 72. Another liver biopsy will be performed at 48 weeks. Some participants may also be part of a smaller study. This study involves frequent blood draws to study drug and virus levels in the blood. The study will require a 36-hour hospital inpatient visit.
HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated
Chronic Hepatitis BHepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive carriers. The researchers aim to investigate the ability of peginterferon alpha-2a to achieve surface antigen loss/seroconversion therapy in inactive carriers with persistently normal alanine aminotransferase (ALT) levels, undetectable HBV DNA and low surface antigen levels, who would not generally be considered candidates for therapy.
A Phase 1 Study of PPI-668 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) Genotype...
Hepatitis CChronicPPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-668 is absorbed into the bloodstream. In Part II, the effect of PPI-668 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.
A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV)...
Hepatitis CThe purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.