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Hepatitis clinical trials

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NCT ID: NCT03819322 Active, not recruiting - Hepatitis C Clinical Trials

The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients

Start date: August 15, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label, pilot trial to test the safety and efficacy of transplantation of livers from Hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the liver transplant waitlist. Treatment and prophylaxis will be administered, using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

NCT ID: NCT03809533 Active, not recruiting - Hepatitis C Clinical Trials

The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients

Start date: May 29, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the kidney transplant waitlist. Treatment and prophylaxis will be administered using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

NCT ID: NCT03801798 Active, not recruiting - Hepatitis B Clinical Trials

A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients

Start date: February 11, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B

NCT ID: NCT03801538 Active, not recruiting - Chronic Hepatitis B Clinical Trials

The Optimizing Treatment of Peginterferon Alpha in Chronic Hepatitis B Patients With Low Level HBsAg

Start date: January 1, 2019
Phase: Phase 4
Study type: Interventional

HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 180 micrograms/week for 12 weeks. At week 12, the decrease of HBsAg was evaluated. ①If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(<0.05 IU/ mL). Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in week 96. After treatment, all patients were followed up for 48 weeks. ②If the decrease of HBsAg is less than 50% compared to baseline level. The combination therapy of NAs and peginterferon alfa was extended to week 24. Then, the decrease of HBsAg was evaluated again. If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(<0.05 IU/mL). Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in week 96. After treatment, all patients were followed up for 48 weeks. If the decrease of HBsAg is less than 50% compared to baseline level. Peginterferon alfa was stopped, patients were treated with NAs once a day and then followed up for 48 weeks. Patients who maintained the original NAs treatment served as a control group.

NCT ID: NCT03777969 Active, not recruiting - Chronic Hepatitis b Clinical Trials

Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

Start date: June 29, 2018
Phase:
Study type: Observational

A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are enrolled. All the patients will receive original antiviral treatment for the following 10 years. Patients will be assessed at baseline and at every six months for blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death, will be collected during follow-up.

NCT ID: NCT03740789 Active, not recruiting - Chronic Hepatitis b Clinical Trials

Evaluation of Antiviral Indications on Chronic HBV Infection With Different Transaminase Levels

Start date: October 24, 2018
Phase:
Study type: Observational

It remains unknown whether antiviral therapy is beneficial for chronic hepatitis B (CHB) with normal or mild ALT.The investigators aim to evaluate the antiviral indications combining liver biopsy and clinical parameters,and further clarify the response indexes of clinical results such as virological, serological, biochemical and histological responses from a retrospective observational cohort study on antiviral therapy in HBeAg positive and negative patients with different ALT levels,especially when ALT lower 2 times upper limit of normal (ULN).

NCT ID: NCT03597633 Active, not recruiting - Clinical trials for Chronic Hepatitis b With Multidrug Resistance

Tenofovir Combination or Mono-therapy for MDR CHB

Start date: June 1, 2013
Phase:
Study type: Observational [Patient Registry]

Treatment of multidrug resistant (MDR) chronic hepatitis B (CHB) is still a challenging issue. Hence, the investigators will perform a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB at real life settings.

NCT ID: NCT03539016 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

Observational Study on Pregnant Women With Chronic Hepatitis B and Their Infants

Start date: July 2015
Phase:
Study type: Observational

The study was conducted to observe the clinical features during pregnancy in women with chronic hepatitis B virus infection and mother-to-child transmission of hepatitis B virus.

NCT ID: NCT03520660 Active, not recruiting - Clinical trials for Cardiovascular Diseases

People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents

Start date: October 19, 2018
Phase: Phase 4
Study type: Interventional

Background: Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why. Objective: To study the course and complications of liver disease after cure of hepatitis C infection. Eligibility: Adults 18 years and older infected with chronic hepatitis C virus who were never treated or were treated and not cured and those who were cured Design: Participants will be screened with: Blood and urine tests Questionnaires Liver ultrasound Fibroscan. A probe vibrates the liver, testing stiffness. In Phase 1, people with chronic hepatitis C will: Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A small piece of liver is removed by needle passed through the skin. Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks. Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional visits in the next 24 weeks with more blood work collected. Phase 1 participants who test negative for hepatitis C and all other eligible participants will enter Phase 2. Phase 2 participants will have a visit every 24 weeks for 10 years. These may include: Repeats of screening tests Questionnaires Scans Stool tests Chest x-ray Heart function test Endoscopy. A tube guides a camera into the upper digestive system. At about 5 years, participants will have another liver biopsy. Some participants will give separate consent for genetic testing and a special blood procedure.

NCT ID: NCT03519113 Active, not recruiting - Clinical trials for Hepatitis B Infection

HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102

Start date: March 29, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.