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Hepatitis, Chronic clinical trials

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NCT ID: NCT03067883 Recruiting - Chronic Hepatitis c Clinical Trials

Efficacy and Safety of Qurevo Plus Ribavirin Based Therapy for Hepatitis C With or Without Cirrhosis in Haemodialysis Patients

Start date: November 9, 2016
Phase: Phase 2
Study type: Interventional

To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients.

NCT ID: NCT03042481 Recruiting - Chronic Hepatitis b Clinical Trials

Off-therapy Response After Stopping Entecavir or Tenofovir

Start date: April 2016
Phase: N/A
Study type: Observational

Pegylated-interferon (Peg-IFN) α-2a, entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are current recommended first-line antiviral therapies for chronic hepatitis B (CHB). Compared with Peg-IFN therapy, nucleot(s)ide analogue (NUC) therapy has the advantages of having a potent antiviral effect, and good tolerance without side effect. The long-term safety and efficacy of ETV and TDF therapy had also been identified. However, poor durability of the effectiveness after stopping NUC therapy are encountered in the majority of patients. Previous study identified a high HBV relapse rate of over 50% in HBeAg- positive CHB patients treated with lamivudine. A recent study investigating the post-treatment durability of ETV showed that higher to 45.3% of the HBeAg-negative CHB patients happened a clinical relapse within 1-year after stopping ETV therapy. TDF is another recommended first line NUC with high potency and high genetic barrier. Although the efficacy of long-term TDF therapy had been identified, there is lack of data regarding the off-therapy response in CHB patients with TDF therapy currently. Only a small scale of patients treated with TDF were included in a recent study investigating off-therapy relapse in non-cirrhotic HBeAg-negative CHB patients after greater than 4 years of NUC therapy. In addition, the factors associated with off-therapy response are also still uncertain. The investigators plan to enrolled 400 CHB patients who had received oral antiviral therapy ETV or TDF and achieved the Asia Pacific association of the study of liver (APASL) criteria of stopping NUC therapy. The aims of the study are to investigate the rate of HBV relapse including virological and clinical relapse in all and between patients with ETV and TDF therapy, and to identify the predictive factors of relapse.

NCT ID: NCT03022006 Recruiting - Chronic Hepatitis C Clinical Trials

Safety and Effect of Elbasvir/Grazoprevir Combination Therapy in Hemodialysis Patients With Chronic Hepatitis C

Start date: January 15, 2017
Phase: Phase 4
Study type: Interventional

The number of hemodialysis patients with chronic renal failure in Japan exceeds 0.3 million and is showing an increasing trend. The rate of infection with hepatitis C virus (HCV) is high in hemodialysis patients, and it has been revealed that the prognosis is poorer in HCV-infected hemodialysis patients compared to uninfected patients; therefore, aggressive therapeutic intervention is required.Investigator previously reported the efficacy and safety of a NS5A inhibitor; daclatasvir and a HCV protease inhibitor; asunaprevir combination therapy for Japanese dialysis patients with genotype 1 HCV infection. However, the duration of the treatment is 24 week, which is quite longer than current standard 12 week therapy . elbasvir/grazoprevir combination therapy is oral anti-HCV 12 week therapy without the use of IFN/ribavirin, and a good therapeutic effect has been reported in Japanese phase II studies . Of note is that these drugs are metabolized mainly in the liver and thus they can be used in patients with chronic renal failure. Recently, David Roth et al reported that the efficacy and safety of elbasvir/grazoprevir combination therapy for patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease. In this report, they revealed that elbasvir/grazoprevir combination therapy could achieve SVR rate of 99% in the modified full analysis set. However, no adequate clinical investigation has been performed in Japan, thus far concerning the therapeutic effect and safety of elbasvir/grazoprevir combination therapy in Japanese hemodialysis patients.

NCT ID: NCT03018821 Recruiting - Clinical trials for Hepatitis B, Chronic

The Study of Two Different Chinese Traditional Medicine Treatment on Chronic Hepatitis B

Start date: January 2017
Phase: N/A
Study type: Interventional

Although the incidence of Hepatitis B has been decreased a lot recently years, there are still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM. This study is a multicenter, randomized, open label, parallel group clinical trial to evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on chronic hepatitis B.

NCT ID: NCT03013556 Recruiting - Chronic Hepatitis Clinical Trials

Study on an Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients

Start date: November 2016
Phase: Phase 4
Study type: Interventional

The current study is a prospective, randomized, open, multi-center investigation. The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA<105copies/ml,HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.

NCT ID: NCT02991638 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Efficacy and Safety of Ibrutinib in Patients With CLL and Other Indolent B-cell Lymphomas Who Are Chronic Hepatitis B Virus Carriers or Occult Hepatitis B Virus Carriers

Start date: November 1, 2016
Phase: Phase 3
Study type: Interventional

Efficacy and Safety of ibrutinib in patients with chronic lymphocytic leukemia and other indolent B-cell lymphomas who are chronic hepatitis B virus carriers or occult hepatitis B virus carriers

NCT ID: NCT02982837 Recruiting - Hepatitis B Clinical Trials

To Study the Effect of Adding on Pegylated Interferon (PEG-INF) Therapy for Patients Diagnosed With Chronic Hepatitis B

RC14/055
Start date: March 2015
Phase: Phase 4
Study type: Interventional

To assess whether PEG-INF (Peglyated - interferon) Add-on therapy in patients of CHB who have achieved a maintained viral suppression (HBV DNA PCR( polymerase chain reaction) <200 for last 3-6 month) with NA's can result in increased rate of HBV infection eradication (HbsAg is undetectable by serological blood testing with or without seroconversion to HBs antibody).

NCT ID: NCT02973646 Recruiting - Chronic Hepatitis b Clinical Trials

Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection

Start date: January 2016
Phase: Phase 4
Study type: Interventional

The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic hepatitis b patients with e antigen positive based on the detection of interferon gene mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.

NCT ID: NCT02965859 Recruiting - Chronic Hepatitis B Clinical Trials

The Safety and Dose-range Study of Metacavir Enteric-coated Capsules in Patients With Chronic Hepatitis B

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

The study objective is to evaluate the safety and effectiveness of different doses of Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an appropriate clinical dosage by comparing the effect of different doses of treatment,in order to provide references of clinical trial of the next phase.

NCT ID: NCT02953600 Recruiting - HBV Carrier Clinical Trials

Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration

Start date: November 2016
Phase: N/A
Study type: Interventional

Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat, long-term, and severe chronic hepatitis would be more possible progressed into liver cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC. In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis phase.