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Hepatitis, Chronic clinical trials

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NCT ID: NCT01938625 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation

Start date: December 12, 2013
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate effect of steady-state (when the amount of drug administered (in a given time period is equal to the amount of drug eliminated in that same period) of simeprevir and daclatasvir on the steady-state pharmacokinetics (what a medication does to the body) of cyclosporine (applicable to Part 1 only) and tacrolimus when administered as a combinational regimen in post-orthotopic liver transplantation (OLT) participants with recurrent hepatitis C virus (HCV) genotype 1b infection and effectiveness of a 24-week treatment regimen containing simeprevir, daclatasvir, and ribavirin (RBV) with respect to the proportion of HCV genotype 1b infected post-OLT participants achieving sustained virologic response 12 weeks after end of treatment.

NCT ID: NCT01937975 Completed - Chronic Hepatitis C Clinical Trials

The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)

Start date: September 6, 2013
Phase: Phase 1
Study type: Interventional

Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal impairment. Both groups were compared to healthy matched controls.

NCT ID: NCT01937728 Completed - Hepatitis C Clinical Trials

Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)

Start date: March 2010
Phase: Phase 4
Study type: Interventional

The purposes of this study are: 1. To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and HVL 2. To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at week 12

NCT ID: NCT01935635 Completed - Chronic Hepatitis B Clinical Trials

A Clinical Trial on HB-Vac Activated-DCs Combined With Peg-IFN or NAs in CHB

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic hepatitis B patients

NCT ID: NCT01928511 Completed - Chronic Hepatitis B Clinical Trials

Efficacy of Switching or Adding Pegylated Interferon in Chronic Hepatitis B Patients on Long Term Oral Antiviral Therapy

SWAP
Start date: January 2014
Phase: Phase 4
Study type: Interventional

Patients with Chronic Hepatitis B on long term oral antiviral therapy have to continue treatment indefinitely unless they achieve HBeAg seroconversion or HBsAg seroclearance, when therapy can be stopped. While HBeAg seroconversion is a more achievable endpoint, only 20-25% of patients develop this after one year of oral antiviral therapy. HBsAg seroclearance is universally infrequent. Strategies to improve these endpoints such as combination oral antiviral therapy have not been generally successful and recently studies have examined the possibility of switching or adding peginterferon therapy. However these have not been tested adequately in the group of patients that have been on long term oral antiviral therapy. Consequently this study was conceived to evaluate whether switching or adding peginterferon compared to continuing oral antiviral therapy are more efficacious strategies. HBeAg positive and HBeAg negative patients (n=310)will be randomised to continue oral antiviral therapy, switch or add pegylated interferon for 48 weeks in a ratio of 1:2:2 respectively. The study endpoints are HBsAg seroclearance, reduction of qHBsAg >1 log, qHBsAg<200 IU/ml, HBeAg loss and seroconversion, and HBV DNA suppression, all at week 72.

NCT ID: NCT01926288 Completed - Chronic Hepatitis B Clinical Trials

Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B

Start date: October 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B

NCT ID: NCT01913431 Completed - Clinical trials for HBeAg-Positive Chronic Hepatitis B

Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B

Start date: September 12, 2013
Phase: Phase 4
Study type: Interventional

This is a multicenter, double blind, active-controlled, randomized, parallel group study to demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48 days.

NCT ID: NCT01911845 Completed - Chronic Hepatitis C Clinical Trials

An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine

Start date: April 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.

NCT ID: NCT01908660 Completed - Clinical trials for Hepatitis C, Chronic

Hepatic Safety of Currently Used Antiretroviral Regimens in Patients With Chronic Hepatitis Under Real Life Conditions

Start date: January 2007
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to compare the liver toxicity in HIV-infected patients with chronic hepatitis B and/or hepatitis C, who start a new antiretroviral drug regimen, as well as the influence of the degree of pre-existing liver fibrosis on the incidence of liver toxicity.

NCT ID: NCT01908335 Completed - Chronic Hepatitis C Clinical Trials

A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C

Start date: October 2012
Phase: Phase 2
Study type: Interventional

This dose-escalating study is to evaluate the efficacy and the safety of different doses of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin(RBV) in the treatment of Chronic hepatitis C who have not been previously treated with Interferon(IFN) by exploring the dose-effect relationship, while identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method is adopted to assess the pharmacokinetic behavior, individuals / intra-individual variability, and the possible factors for further study.