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Hepatitis clinical trials

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NCT ID: NCT02129829 Completed - Clinical trials for Hepatocellular Carcinoma

PROLIFICA - West African Treatment Cohort for Hepatitis B

WATCH
Start date: October 2011
Phase:
Study type: Observational

The West African Treatment Cohort for Hepatitis B (WATCH) study is a component of the European Commission Funded FP7 project PROLIFICA. It aims to evaluate a number of steps required to successfully treat patients with chronic hepatitis B virus infection to prevent cirrhosis and liver cancer. The first step is to determine whether screening for hepatitis B using a point of care test is feasible and effective. The second is to monitor linkage from screening into care. The third is to evaluate cheap non-invasive assessments to determine the need for treatment. The fourth is to determine what proportion of patients meet treatment eligibility criteria. The fifth step is to establish a treatment cohort which can be used to measure adherence to therapy and avoidance of HBV related complications. A parallel untreated cohort will be established to determine whether treatment criteria are relevant in this West African setting by monitoring for complications of HBV infection.

NCT ID: NCT02128217 Completed - HIV-1 Infection Clinical Trials

Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection

SWIFT-C
Start date: May 30, 2014
Phase: Phase 1
Study type: Interventional

Early identification of acute HCV infection is essential to prevent chronic infections and the long-term liver disease complications that may occur. Early identification and treatment of HCV during the acute phase can result in significantly higher response rates with shorter durations of therapy. Pegylated-interferon alfa (PEG-IFN) was the typical treatment for HCV infection. Participants subcutaneously inject PEG-IFN where the average duration of treatment was approximately 20 weeks. With the advancement of direct-acting antivirals (DAAs), it was possible to see if a new DAA might be non-inferior compared to (PEG-IFN). The study was designed to see if a fixed-dose combination tablet can replace the old HCV treatments by being more effective, safer and better tolerated in HIV-infected participants with new HCV infection. The study was a Phase I, open-label, two cohort clinical trial, in which 44 acutely HCV-infected HIV-1 positive participants were enrolled. Participants in each cohort were evaluated in two steps: on treatment (Step 1) and follow-up after discontinuing study treatment (Step 2). The cohorts were enrolled sequentially. Participants in Cohort 1 were enrolled and administered oral Sofosbuvir (SOF) in combination with weight-based ribavirin (RBV). Participants in Cohort 2 were enrolled and administered an oral fixed dose combination of Ledipasvir/Sofosbuvir (LDV/SOF).

NCT ID: NCT02126696 Completed - Depression Clinical Trials

Comorbidities and Virologic Outcome Among Patients on Anti-retroviral Therapy in Rural Lesotho

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

This study is conducted in a cohort of HIV-positive patients on first-line anti-retroviral therapy (ART) in rural health facilities in Lesotho, Southern Africa. It examines virologic treatment failure as well as chronic communicable and non-communicable comorbidities among patients on ART. The study has two phases. Phase 1 consists of a cross-sectional survey to determine prevalence of treatment failure as well as the prevalence of the following comorbidities: diabetes mellitus, arterial hypertension, dyslipidemia, depression, alcohol use disorder, hepatitis B and hepatitis C. Phase 2 is a cohort study, where patients with treatment failure or a comorbidity or both are followed-up for 12 months.

NCT ID: NCT02125500 Completed - HIV Clinical Trials

Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-dose Combination in Treatment Experienced Subjects With Hepatitis C Virus (HCV) Genotype 1 - HIV Co-infection

Start date: August 2014
Phase: Phase 2
Study type: Interventional

Aim of the study is to assess the efficacy and safety of 24 weeks of oral Sofosbuvir/Ledipasvir fixed-dose combination (FDC) in subjects with HCV genotype 1 infection and HIV co-infection, who have previously failed a NS3/4A protease inhibitor plus Pegylated interferon /ribavirin regimen or stopped prematurely their treatment for intolerance.

NCT ID: NCT02125071 Completed - Liver Cirrhosis Clinical Trials

Study on the Pharmacokinetic Characteristics of I.V. Hepabig Injection Used for Prevention of Hepatitis B Relapse After Liver Transplantation

LT
Start date: November 2013
Phase: N/A
Study type: Observational

An exploratory clinical trial to evaluate the pharmacokinetic characteristics of I.V. Hepabig injection used for prevention of hepatitis B relapse after liver transplantation.

NCT ID: NCT02123654 Completed - Clinical trials for Hepatitis C Virus Infection

UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).

NCT ID: NCT02123212 Completed - Hepatitis C Clinical Trials

Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C

Best-C
Start date: February 2013
Phase: N/A
Study type: Interventional

The Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C) compares the effectiveness of the birth cohort HCV screening strategy with the current risk-based screening approach to detect previous unidentified persons with viral hepatitis C who receive health care in primary systems. The study involved three clinical sites, The University of Alabama, Birmingham; The Henry Ford Health System; and the Mount Sinai Medical Center, each of which developed an independent intervention to experimentally compare the number of positive Hepatitis C Virus (HCV) diagnoses found using the birth-cohort screening approach with that found using traditional risk-based screening, or standard of care strategies. Birth cohort testing is defined as the systematic recommendation of HCV antibody testing to any persons born during the years of 1945 to 1965 who do not have clinically documented evidence of a prior antibody test without regards to the patient's stated risk of exposure to the virus.

NCT ID: NCT02118012 Completed - Chronic Hepatitis C Clinical Trials

Evaluation of Safety, Tolerability, and Antiviral Activity of Chlorcyclizine HCl in Patients With Chronic Hepatitis C

Start date: March 20, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Hepatitis C is a liver disease caused by the hepatitis C virus. It is the most common cause of serious liver disease in the United States. Many people have few if any symptoms. It can lead to cirrhosis, which can cause liver failure and cancer. Researchers want to study how a medicine called chlorcyclizine works in patients with hepatitis C. They want to see if it can be used to treat hepatitis C alone or when used with the standard hepatitis C treatment drug ribavirin. Objectives: - To see if chlorcyclizine can be used to treat hepatitis C alone or in combination with the drug ribavirin. Eligibility: - Adults with chronic hepatitis C who either have never been treated for it or have relapsed after prior treatment. Design: - Participants will be screened with medical history, physical exam, blood and urine tests, and a questionnaire. They will also have an ultrasound of their abdomen and electrocardiogram. Some of these tests will be repeated throughout the study. - Participants will spend 3 days as an inpatient to be monitored while starting study drug. They will be assigned randomly to a group and will begin taking the study drug. Blood will be taken frequently. - Group I will take the study drug twice a day for 28 days. - Group II will take the study drug twice a day and ribavirin twice a day for 28 days. - Participants will visit the clinic every 7 days for 28 days. - After participants stop taking the study drug, they will have 5 follow-up visits over 3 months.

NCT ID: NCT02116543 Completed - Hepatitis C Clinical Trials

TD-6450 MAD Study in HCV Infected Subjects

Start date: May 2014
Phase: Phase 1
Study type: Interventional

This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.

NCT ID: NCT02116179 Completed - Hepatitis C Clinical Trials

DVD-based HIV/HCV Prevention Intervention for Drug-Involved Latino Criminal Justice Clients

Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of the study are the following: 1) Pilot test and conduct baseline and 3 month follow up assessments to evaluate the preliminary efficacy of the DVD-based HIV/HCV intervention by randomly assigning 210 Latino corrections-involved, outpatient abuse treatment clients to either the experimental intervention or to a wait list control group; and 2) to evaluate both participant and interventionist acceptability of this novel DVD-based intervention. They study hypothesis are the following: 1. participants in the intervention condition will report greater reductions in sexual risk behaviors (e.g., unprotected sexual contact) from baseline to 3 month follow-up compared to the control group; 2. participants will report greater reductions in drug risk behaviors (e.g., sharing injection equipment, drug use during sex) from baseline to 3 month follow-up compared to the control group; 3. participants who report more HIV prevention information, motivation, and behavioral skills will report fewer sexual risk behaviors.