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Hepatitis, Chronic clinical trials

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NCT ID: NCT04189627 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation

DETI-2
Start date: February 17, 2020
Phase:
Study type: Observational

The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir [PRS]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.

NCT ID: NCT04182321 Completed - Chronic Hepatitis B Clinical Trials

Metformin as Add-on to the Standard Therapy in Patients With Chronic Hepatitis B

Start date: March 13, 2020
Phase: N/A
Study type: Interventional

This is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis B.

NCT ID: NCT04032275 Completed - Chronic Hepatitis B Clinical Trials

Correlation Between Virus and Biochemical Characteristics and Liver Histological Damage in Untreated Chronic HBV Infection

Start date: January 1, 2018
Phase:
Study type: Observational

This study is a retrospective study. Enrollment study. Enrolled in the Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Department of Liver Histology, Department of Hepatology, Chronic HBV HBV infection. The data collected included patient gender, . The data collected included patient gender, . The data collected included the patient's gender, age, HBV age of infection, past family history, etc., the age of the collected subjects, the current family history, etc., the liver histopathological diagnosis information collected in the group, and the liver disease examination Clinical toxicities and indicators, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serum HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe content, biochemical indicators coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Observe patient demographic data, HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe HBe content, biochemical indicators, coagulation Correlation between function and routine, coagulation function and conventional indicators and liver histological changes. Explore the relevance of effective diagnosis of liver changes. To explore the characteristics of clinical indicators that can effectively diagnose liver histopathological changes, and to provide clinical indicators for patients with chronic hepatitis B to receive timely treatment of histopathological changes, and provide important evidence for patients with chronic hepatitis B to receive timely treatment.

NCT ID: NCT04028856 Completed - Chronic Hepatitis B Clinical Trials

Cohort Study of Efficacy and Safety of Interferon Intermittent Treatment of Chronic Hepatitis B

Start date: June 1, 2018
Phase:
Study type: Observational

This study was a retrospective clinical observational cohort study. All patients with chronic hepatitis B (CHB) whose HBsAg decreased by less than 10% were treated continuously with interferon in the Department of Hepatology, Beijing Ditan Hospital, Beijing Medical University, Beijing Capital University, 2008.10-2017.4. The total interferon treatment time of the enrolled subjects was 48 weeks. The subjects were randomly divided into the following two observation cohorts: 1) patients with chronic hepatitis B treated with continuous interferon for 48 weeks; 2) intermittent interferon For 48 weeks of treatment for patients with chronic hepatitis B, the interferon treatment interval was 3 months. HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe and biochemical markers, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline) and during treatment. The primary outcome measure was the rate at which HBsAg disappeared at 48 weeks of treatment. The secondary evaluation index was the 48-week HBeAg seroconversion rate. To investigate the efficacy, influencing factors and safety of interferon intermittent treatment of chronic hepatitis B.

NCT ID: NCT03995485 Completed - Clinical trials for Hepatitis C, Chronic

KW-136 With Sofosbuvir for Chinese Adults With Chronic Hepatitis C

KW-136_III
Start date: June 7, 2017
Phase: Phase 3
Study type: Interventional

This study aimed to confirm efficacy and safety of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of naive and experienced adults chronically infected with HCV. Three hundred and sixty (360) non-cirrhotic and cirrhotic subjects were medicated with KW-136 60 mg daily and sofosbuvir 400 mg daily. The treatment course lasted 12 successive weeks; thereafter all the study participants entered into a 12-week treatment-free follow-up period and an additional 12-week extension treatment-free follow-up period.

NCT ID: NCT03905655 Completed - Chronic Hepatitis B Clinical Trials

Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B

Start date: October 22, 2019
Phase: Phase 2
Study type: Interventional

This randomized controlled trial is designed to evaluate safety, effectiveness and pharmacokinetic-pharmacodynamic (PK/PD) relationships associated with three different Nitazoxanide (NTZ) treatment regimens added to Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF) or Entecavir (ETV) in treating Chronic Hepatitis B (CHB).

NCT ID: NCT03868163 Completed - Clinical trials for Chronic Hepatitis C (CHC)

Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation

EVEREST
Start date: February 28, 2019
Phase:
Study type: Observational

This study seeks to assess the effectiveness of Glecaprevir plus Pibrentasvir in participants with chronic hepatitis C in a real-life setting across clinical practice populations in the Russian Federation.

NCT ID: NCT03852433 Completed - Clinical trials for Chronic Hepatitis Delta

Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)

Start date: May 31, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of bulevirtide combination with pegylated interferon in participants with chronic hepatitis delta (CHD).

NCT ID: NCT03847246 Completed - Chronic Hepatitis b Clinical Trials

Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers

Start date: December 4, 2018
Phase: N/A
Study type: Interventional

A single-center, open-Label, randomized, single-dose, two-period, two-sequence, crossover study to assess the bioequivalence of test formulation entecavir tablets 1.0 mg with reference formulation entecavir tablets (Baraclude®) 1.0 mg in healthy adult subjects under fasting conditions.

NCT ID: NCT03833362 Completed - Hepatitis C Clinical Trials

Efficacy and Safety of Narlaprevir Used in Combination With Ritonavir in Treatment-Naïve and Failed Prior Treatment With Pegylated Interferon/Ribavirin Patients With Chronic Hepatitis C Genotype 1 (PIONEER - Study)

PIONEER
Start date: May 7, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to confirm that combination of narlaprevir (NVR) and ritonavir (RTV) used as a metabolic inhibitor with pegylated interferon (PEG-INF) and ribavirin (RBV) leads to a superior Sustained Virological Response (SVR) rate compared to treatment with pegylated interferon and ribavirin in treatment-naïve and treatment failure patient populations.