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Hepatitis, Chronic clinical trials

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NCT ID: NCT02505009 Completed - Chronic Hepatitis B Clinical Trials

Efficacy of HBV Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy

Start date: May 1, 2015
Phase: Phase 4
Study type: Interventional

Background and aims: Nucleos(t)ide analogues may suppress HBV DNA to undetectable level, but only about 30-40% remain sustained response 1-3 years after discontinued therapy. The investigators will try to improve the sustained response rate by given a course of HBV vaccination during the last 6 months on patients receiving a 3-year entecavir or tenofovir therapy. Rational: The host may response to HBV vaccine when HBV DNA and immune tolerance are suppressed during entecavir or tenofovir therapy. Patients: Patients who have been receiving entecavir or tenofovir therapy for at least 30 months will be invited to this study. The case group will receive 5 Engerix-B injections during the last 6 months of entecavir or tenofovir therapy. Arm A-entecavir pretreated group: 75 cases will be enrolled to receive Engerix-B injection and compared with histological non-vaccine treated controls; Arm B-tenofovir pretreated group: 50 patients will be randomized into case (vaccine) and control group according to age, gender, pretreatment HBV DNA level. Therapy: Both case and control groups will receive a 3 year or longer entecavir or tenofovir therapy. Patients will be screen at 24-30 months and enrolled at 30 months after entecavir or tenofovir therapy. They will receive 5 Engerix-B injections at 0,1st ,2nd,3rd and 6th month [30-36 +/-1 month post nucleos(t)ide therapy] post enrollment. Both drugs will be discontinued after completed therapy. Follow-up: Both groups will be monitoring by biochemistry, alpha-fetoprotein, quantitative HBsAg, HBV DNA levels and immunological parameter periodically for 2 years after therapy. Efficacy: Those patients with persistent normal ALT and HBV DNA lower than 1*100000 cps/mL after discontinued nucleos(t)ide analogues therapy will be considered to have sustained response. Patients with transient elevation of HBV DNA and ALT, but normalized spontaneously without further therapy will be defined as delayed response. Patients with persistent HBV DNA greater than 1*100000 cps/mL will be considered to have non-sustained response. Study duration: The enrollment will be completed in one year and keep on observation for additional 2 years. Expected goals of the study: HBV vaccine and nucleos(t)ide analogues combination therapy may decrease the HBV relapse rate at 1 and 2 year after completed therapy.

NCT ID: NCT02504099 Terminated - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma

GEODE - I
Start date: July 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.

NCT ID: NCT02498015 Completed - Clinical trials for Hepatitis C, Chronic

A Phase IV Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir for Chronic Hepatitis C Genotype 1 Virus Infection

D3FEAT
Start date: August 2016
Phase: Phase 4
Study type: Interventional

A total of 100 people with chronic HCV and recent injection drug use or recipients of opioid substitution therapy will be enrolled in 5 countries and 21 study sites. Participants with genotype 1a infection or cirrhosis will receive 12 weeks of open-label paritaprevir/ritonavir/ombitasvir and dasabuvir ("3D"), and twice-daily ribavirin. Participants with genotype 1b infection without cirrhosis will receive 12 weeks of open-label "3D". The study consists of a screening phase (6 weeks), treatment phase (12 weeks) and follow-up phase (96 weeks) to evaluate treatment response and reinfection.

NCT ID: NCT02496078 Completed - Hepatitis C Clinical Trials

A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

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

The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.

NCT ID: NCT02493855 Completed - Chronic Hepatitis C Clinical Trials

Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

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

To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.

NCT ID: NCT02487199 Completed - Clinical trials for Hepatitis C Virus (HCV)

Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease

Start date: September 30, 2015
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.

NCT ID: NCT02486406 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects

ZIRCON
Start date: October 28, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.

NCT ID: NCT02485080 Withdrawn - PT-NANBH Clinical Trials

Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1

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

The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.

NCT ID: NCT02482272 Recruiting - Clinical trials for Hepatitis B, Chronic

Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B

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

The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir

NCT ID: NCT02482077 Completed - Clinical trials for Chronic Hepatitis C Infection

Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients

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

The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2 infection.