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Hepatitis, Chronic clinical trials

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NCT ID: NCT02533544 Completed - Chronic Hepatitis B Clinical Trials

Treatment Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B

Start date: October 2015
Phase:
Study type: Observational

This is an open-label, single arm cohort study to see efficacy and safety of tenofovir disoproxil fumarate (TDF) in naïve chronic hepatitis B, retrospectively and prospectively both.

NCT ID: NCT02532413 Recruiting - Chronic Hepatitis B Clinical Trials

Antiviral Efficacy of the Combination Treatment With Poly IC and Entecavir for Chronic Hepatitis B

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

The purpose of this study is to investigate antiviral efficacy of the combination treatment with Poly IC and Entecavir and compare with the efficacy of Entecavir mono-therapy for chronic hepatitis B.

NCT ID: NCT02531269 Completed - Hepatitis C Clinical Trials

Effectiveness Of Daclatasvir-Based Regimens In Patients With Chronic Hepatitis C Infection In Europe: Experience From Named Patient Program And From Early Post-Marketing Authorization Period

Start date: March 2015
Phase: N/A
Study type: Observational

Using European data from patients included in the Named Patient Program (NPP) and from the early post-marketing authorization period, the present study aims to describe patient characteristics and to describe the effectiveness of Daclatasvir (DCV)-based regimens in Europe. This will be a retrospective cohort study of patients who received treatment with a DCV-based regimen in the following context: - Patients enrolled within the European NPP in one of the following countries Austria, Denmark, Italy, Sweden, Spain, Switzerland, United Kingdom; or - In those countries where DCV is commercially available (ie, Sweden, Germany, United Kingdom), patients who received DCV during the early post-marketing authorization period The results of this study will contribute to a better understanding of effectiveness of DCV-based regimens in a population that differs from population in the clinical trials, and therefore will provide additional valuable information to inform clinical practice. This study intends to estimate primarily the effectiveness of DCV-based regimens as measured by the sustained virologic response at post treatment follow-up visit week 12 (SVR12). As well as estimate the effectiveness of DCV-based regimens as measured by SVR12 after the end of Hepatitis C virus (HCV). This study intends also to describe as secondary objectives the characteristics (ie, demographic and clinical characteristics and treatment patterns of patients starting a new DCV-based regimens) of patients receiving DCV as well as the effectiveness of DCV-based regimens as measured by: - On-treatment virological response at post treatment follow-up visit Week 4; and - Virological response at the end of treatment (EOT); and - The sustained viral response at post treatment follow-up visit Week 4 (SVR4) and post treatment follow-up visit Week 24 (SVR24); and - The occurrence of virological failure (on-treatment and relapse). An exploratory objective will be to assess the concordance between SVR4 and SVR12 among the overall population treated with DCV.

NCT ID: NCT02523547 Recruiting - Chronic Hepatitis B Clinical Trials

Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude

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

Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.

NCT ID: NCT02517528 Completed - Clinical trials for Chronic Hepatitis C Virus (HCV)

ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis

Start date: July 20, 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced Asian adults with compensated cirrhosis.

NCT ID: NCT02517515 Completed - Clinical trials for Hepatitis C Virus (HCV)

ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

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

This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.

NCT ID: NCT02511743 Completed - Hepatitis B Clinical Trials

Knowledge and Practice of Chinese Medical Specialists Regarding Chronic Hepatitis B Virus Infection

Start date: April 2015
Phase: N/A
Study type: Observational

The aim of this study was to evaluate knowledge and behavior of physicians regarding Hepatitis B Virus. The investigators designed a 30-item self-administered questionnaire assessing physicians' knowledge and behavior regarding chronic Hepatitis B Virus infection. These results provide data support for updating guidelines, continuing training, and even developing policies in medical insurance.

NCT ID: NCT02511496 Not yet recruiting - Chronic Hepatitis C Clinical Trials

Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia

Start date: September 2015
Phase: N/A
Study type: Observational [Patient Registry]

This study evaluates the current situation and follow-up of chronic hepatitis C virus (HCV) infection in patients co-infected with human immunodeficiency virus (HIV) in Andalusia.

NCT ID: NCT02510248 Terminated - Clinical trials for Chronic Hepatitits C

First in Human Study of AL-704; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C

Start date: July 31, 2015
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part study in which the safety, tolerability, and pharmacokinetics of orally administered AL-704 will be assessed in healthy adult subjects and in adult subjects with CHC infection. Part 1: Healthy adult subjects will receive one of 5 single ascending oral doses (SAD) of AL-704 ranging from 100 mg to 1,500 mg (Cohorts 1 to 5). Within each cohort subjects will be randomized to receive either AL-704 or placebo (n=8 per cohort; 6 assigned to AL-704 and 2 assigned to placebo), in a fasted state. The planned dose-escalation scheme may be changed based on the emerging PK and safety data. Two additional cohorts (Cohorts 6 and 7) may be enrolled for evaluation of additional doses at the discretion of the Sponsor and Investigator, based on the emerging pharmacokinetic (PK) profile, and the presence of an acceptable safety profile. Part 2: To assess the food effect on pharmacokinetics, 8 healthy subjects from one full Part 1 cohort who received a single dose of AL-704 or placebo in a fasted state, will receive the same single dose of AL-704 or placebo in a fed state in Part 2 after a washout period of 7-14 days (depending on PK results). It is expected that Cohort 3 of Part 1 (600 mg dose) will be selected, however this depends on the evaluation of available PK and safety data from Part 1 of the study. Part 3: The following cohorts of 10 adult subjects each, with CHC infection, will be evaluated. Subjects with CHC genotype 1 infection (Cohorts 8 to 10) and subjects with CHC genotype 3 infection (Cohort 11) will be randomized to receive AL-704 or placebo for 7 consecutive days (n=10 per cohort, 8 assigned to AL-704 and 2 assigned to placebo) in a fed state. The treatment is anticipated to be administered in a once daily dose regimen or a twice daily dose regimen. The dose and dose regimen to be administered will be determined by the Sponsor depending on the PK and safety outcomes of previous cohorts.

NCT ID: NCT02508090 Completed - Chronic Hepatitis C Clinical Trials

Long-Term Extension Study of Miravirsen Among Participants With Genotype 1 Chronic Hepatitis C (CHC) Who Have Not Responded to Pegylated-Interferon Alpha Plus Ribavirin

Start date: August 2, 2013
Phase: N/A
Study type: Observational

Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as an investigational product.