Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects
Chronic Hepatitis bThis is a single center, open-label, 3-Cohort, parallel, single-dose, study to evaluate the PK, safety, and tolerability of ATI-2173 50 mg administered orally in Japanese, Chinese, and Non-Asian healthy subjects incorporating a food effect analysis in Non-Asian healthy subjects.
Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis...
Hepatitis BHepatitis DPatients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be evaluated for safety and efficacy.
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic...
Hepatitis BPatients with chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.
HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic...
Hepatitis BThis is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B (NCT01369212) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199). This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and NCT01369199) to define natural history and treatment outcome.
Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic...
Hepatitis BChronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be evaluated for safety and efficacy.
Comparison Between Lamivudine and Entecavir Treatment in Spontaneous Severe Acute Exacerbation
Chronic Hepatitis BThis is a prospective, observational, open-label, 2-arm, parallel, multi-center study. Patients with HBV-associated severe acute exacerbation for whom the treatment with NRTI (such as lamivudine and entecavir) is medically recommended will be screened for eligibility. To target 74 evaluable subjects, approximately 82 patients should be recruited into this trial. After enrollment, all eligible subjects will be randomly assigned to one of the antiviral treatments below. Cohort 1: Lamivudine 100 mg p.o. q.d. Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment. The efficacy and safety data will be collected at baseline, 3, 5, 8, 15, 22, 29, 85, and 180 days after initiation of antiviral treatment. All assessments should be conducted based on routine practice of each hospital. Only the analysis of HBV DNA and anti-HDV will be performed in the central lab. For patients who are willing to provide the residual samples of HBV DNA assessment, the blood samples will be preserved appropriately. All AE(s) and SAE will be followed until resolution or the event is considered stable.
A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis...
Hepatitis BChronic Hepatitis B4 moreThe purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALN-HBV in healthy adult volunteers and patients with chronic hepatitis B virus (HBV) infection. In addition, the study will assess antiviral efficacy of ALN-HBV in patients with HBV.
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving...
Chronic Hepatitis BThe purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.
Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201
Hepatitis BChronicCompare the long-term safety of pradefovir to adefovir dipivoxyl
Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection...
Hepatitis BChronic hepatitis B infection is a major public health issue in Senegal. The study will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine (12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative hepatitis B virus (HBV) infection and an increase in hepatic enzymes.