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Hepatitis, Chronic clinical trials

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NCT ID: NCT02480712 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

ASTRAL-5
Start date: July 1, 2015
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.

NCT ID: NCT02480686 Completed - Clinical trials for Chronic Hepatitis C Infection

Neutrino Regimen for Treatment-experienced HCV GT1 Patients

Start date: January 2015
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.

NCT ID: NCT02480166 Completed - PT-NANBH Clinical Trials

Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6

Start date: June 2015
Phase: Phase 4
Study type: Interventional

The primary objectives of this study are to describe the efficacy of: 1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6 2. 12-week treatment of SOF/LED for all other HCV-6 populations

NCT ID: NCT02479880 Terminated - Hepatitis B Clinical Trials

Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection

Start date: July 3, 2015
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents. This includes prospectively evaluating and comparing the bone mineral density (BMD) change between CHB-infected adolescents 12 to < 18 years of age treated with tenofovir DF in European treatment centers who are assigned to one of two schedules for renal and bone laboratory monitoring and BMD measurement.

NCT ID: NCT02476695 Recruiting - Cirrhosis Clinical Trials

FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis

Start date: May 2014
Phase: N/A
Study type: Observational

This prospective and multicenter study is to determine the diagnostic performance (accuracy, specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the reference. Approximately 600 patients will be enrolled to guarantee 500 final statistical cases; and ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of cirrhosis), respectively. For each stage, the case is assigned as equally as possible.

NCT ID: NCT02476617 Completed - Chronic Hepatitis C Clinical Trials

Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults

Start date: June 2015
Phase: Phase 3
Study type: Interventional

A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12 weeks.

NCT ID: NCT02474316 Recruiting - Chronic Hepatitis B Clinical Trials

Combined Therapy With Peginterferon Alfa-2a With NA in NA-treated HBeAg Positive Patients

Start date: August 2014
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows: Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg qd for 48 weeks

NCT ID: NCT02473211 Completed - Clinical trials for Chronic Hepatitis C Infection

SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Start date: January 2015
Phase: Phase 2/Phase 3
Study type: Interventional

For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.

NCT ID: NCT02470858 Completed - Clinical trials for Chronic Hepatitis C Infection

Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

Start date: January 2015
Phase: Phase 2
Study type: Interventional

The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.

NCT ID: NCT02468648 Completed - Chronic Hepatitis C Clinical Trials

Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816

Start date: June 9, 2015
Phase: Phase 2
Study type: Interventional

Background: - Chronic hepatitis C is a serious liver disease. Current treatments have side effects. New drugs have been developed, but they work better in some people than others. Researchers want to learn why. Objective: - To learn why new hepatitis C drugs sometimes do not work. Also, to learn if these drugs are safe and how well they work in people with different virus strains. Eligibility: - Adults age 18 and older who are infected with hepatitis C virus genotypes 1-4 and who have either never been treated or treated previously with an interferon regimen (with or without ribavirin) that failed to clear the virus. Design: - Participants will be screened with medical history and physical exam. They will have blood and urine tests and complete questionnaires. - Participants will have a Fibroscan, an ultrasound that measures liver stiffness and other liver scans. They will have an electrocardiogram. - Eligible participants will have a liver biopsy. - Participants will be admitted to the Clinical Center. They will have a physical exam and blood tests, and complete questionnaires. - They will take the first study drug dose as a tablet taken once daily. - Participants will take the drug at home for 12 weeks. - Participants will have 6 study visits. They will have blood and vital signs taken, and complete questionnaires. - At week 4, participants will have another liver biopsy. - After their last drug dose, participants will have 5 follow-up visits. They will have blood and vital signs taken, and complete questionnaires. They will discuss their medications and side effects. They may have another Fibroscan.