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Hepatitis clinical trials

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NCT ID: NCT02337127 Recruiting - Chronic Hepatitis B Clinical Trials

Lamivudine Extending Therapy in Chronic Hepatitis B Patients After 3-year of Oral Antiviral Agents

Start date: June 2011
Phase: Phase 4
Study type: Interventional

Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months apart (primary treatment endpoint). Stopping treatment can be considered if undetectable HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative patients. However, oral antiviral drugs currently approved for the treatment of CHB have relatively limited sustained long-term efficacy and a large proportion of patients will suffer from HBV recurrence after stopping treatment.

NCT ID: NCT02336139 Completed - Hepatitis C Clinical Trials

A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use

SIMPLIFY
Start date: March 16, 2016
Phase: Phase 2
Study type: Interventional

To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug use.

NCT ID: NCT02335632 Unknown status - Clinical trials for Alcoholic Liver Disease

Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

Start date: December 2012
Phase: Phase 4
Study type: Interventional

Background/Aims: The investigators explored the therapeutic effects of probiotics in patients with AH. Methods: Between December 2012 and January 2015, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis were checked at baseline and again after therapy.

NCT ID: NCT02333292 Completed - Clinical trials for Chronic Hepatitis C Infection

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

FPSMON201401
Start date: December 2014
Phase:
Study type: Observational

Objectives: 1) To evaluate la proportion of hepatitic C virus (HCV)-monoinfected patients who show sustained virologic response (SVR) to treatment including direct-acting antivirals (DAAs) in the clinical practice in clinical units that treat infectious diseases and 2) to determine the frequency of adverse events, including those that are severe and/or cause treatment interruption, in DAA-based therapy in this setting. Design: Multicentric, prospective post-authorised cohort study. Setting: Hospitals of the Hepatitis Study Group (GEHEP) of the Spanish Society of Infectious Diseases and Microbiology (SEIMC). Study population: HCV-monoinfected patients that initiate DAA-based treatment outside clinical trials. Variables: The primary efficacy outcome variable is the proportion of patients who reach undetectable HCV-RNA 12 weeks after the scheduled end of therapy (SVR12). The primary safety outcome variable is the percentage of subjects who discontinue therapy due to adverse events. Statistical analysis: A descriptive study will be performed, as well as a double sensibility analysis of the frequency of SVR12 using both an intention-to-treat and an on-treatment approach. Those variables that are associated with SVR12 with a p-value <0.2 will be included in a logistic regression analysis in which SVR12 will be the dependent variable.

NCT ID: NCT02332720 Completed - Hepatitis C Clinical Trials

Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012)

Start date: January 28, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, three-part, parallel-group, open-label trial of grazoprevir (MK-5172) (100 mg) and uprifosbuvir (MK-3682) (300 mg or 450 mg) with either elbasvir (MK-8742) (50 mg) or ruzasvir (MK-8408) (60 mg), and with or without ribavirin (RBV), in treatment-naive (TN) or treatment-experienced (TE) cirrhotic (C) or non-cirrhotic (NC) participants infected with hepatitis C virus (HCV) genotype (GT) 3, GT4, GT5, or GT6. Part A will consist of 4 arms to evaluate the safety of dose combinations. In Part B, participants will take 2 uprifosbuvir (+) grazoprevir (+) ruzasvir (MK-3682B) fixed dose combination (FDC) tablets once daily (q.d.) by mouth, with or without twice-daily (b.i.d.) RBV (200 mg capsules; weight-based dosing). Participants who relapse following completion of therapy in Part A will be offered the option of retreatment with 16 weeks of uprifosbuvir (+) grazoprevir (+) ruzasvir with RBV in Part C (data obtained from Part C will not be used in the analysis of outcome measures).

NCT ID: NCT02332707 Completed - Hepatitis C Clinical Trials

Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011)

Start date: January 22, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, three-part, open-label trial of grazoprevir (GZR; MK-5172) (100 mg) and uprifosbuvir (UPR; MK-3682) (300 mg or 450 mg), with either elbasvir (EBR; MK-8742) (50 mg) or ruzasvir (RZR; MK-8408) (60 mg), and with or without ribavirin (RBV), in treatment-naïve (TN) cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) participants with chronic HCV genotype (GT) 1 or GT2 infection. Part A will consist of 8 arms to evaluate the safety of dose combinations. In Part B, participants will take 2 UPR+GZR+RZR fixed dose combination (FDC) tablets once daily (q.d.) by mouth, with or without twice-daily (b.i.d.) RBV (200 mg capsules; weight-based dosing). Participants who relapse following completion of therapy in Part A will be offered the option of retreatment with 16 weeks of UPR+GZR+RZR with RBV in Part C (data obtained from Part C will not be used in the analysis of outcome measures).

NCT ID: NCT02332473 Completed - Chronic Hepatitis B Clinical Trials

A Prospective Study of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis B

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

This study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized to one of the 2 groups to receive different antiviral treatment.

NCT ID: NCT02327702 Not yet recruiting - Pregnancy Clinical Trials

Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

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

This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.

NCT ID: NCT02327676 Not yet recruiting - Clinical trials for Hepatitis B, Chronic

Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

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

This study evaluates generic emtricitabine(FTC) in Chinese naive children chronic hepatitis B patients. Single group of child patients were enrolled, which include HBeAg positive and negative Chronic hepatitis B(CHB)group.

NCT ID: NCT02327663 Not yet recruiting - Clinical trials for Hepatitis B, Chronic

Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

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

This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.