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Hepatitis D clinical trials

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NCT ID: NCT05683548 Available - Clinical trials for Hepatocellular Carcinoma

Replicor Compassionate Access Program

RCAP
Start date: n/a
Phase:
Study type: Expanded Access

The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to response to other other antiviral agents either approved or under development and who are in danger of progressing to decompensated cirrhosis. This compassionate access program will provide access to a once weekly regimen of subcutaneously (SC) administered REP 2139-Mg for a period of 48 weeks with the goal of achieving functional cure of HDV and or HBV, with the reversal of liver disease in the absence of antiviral therapy. The safety, tolerability and efficacy of SC REP 2139-Mg will be monitored during and after therapy

NCT ID: NCT05674448 Terminated - Clinical trials for Chronic Hepatitis B and Hepatitis D Co-infection

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection

Start date: August 11, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis B and hepatitis D co-infection. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV/HDV.

NCT ID: NCT05669677 Active, not recruiting - NAFLD Clinical Trials

Study to Determine the Response to COVID-19 Vaccination and Prevalence of COVID-19 in Subjects With Chronic Liver Disease

Start date: March 15, 2023
Phase:
Study type: Observational

Background: The COVID-19 global pandemic killed more than 6 million people worldwide. Several vaccines have been developed against the virus that causes this disease. These vaccines are effective at preventing severe symptoms and death from COVID-19. Some people with chronic liver disease, especially those with an advanced condition called cirrhosis, do not respond to many vaccines as well as healthy people do. The goal of this natural history study is to find out how well people with chronic liver disease respond to the COVID-19 vaccines. Objective: To learn how chronic liver disease affects the body s immune response to vaccination against COVID-19. Eligibility: People aged 18 years or older with chronic liver disease. They must also be enrolled in protocol 91-DK-0214 or 18-DK-0091. Design: Participants will have 3 visits, each spaced 6 months apart. Each visit will last 2 hours. Participants will have their vital signs recorded. These include age, sex, race, height, and weight. They will give their medical history. At each visit, participants will have blood drawn through a needle inserted into a vein in the arm. The sample drawn at each visit will be from 1 to 8 tablespoons. At each visit, participants will fill out a questionnaire. They will answer questions about whether they have been vaccinated against COVID-19; whether they have had COVID-19; and whether they have been exposed to someone who had COVID-19. The questionnaire will take 10 to 15 minutes. Researchers will also look at results of past blood tests from other research studies.

NCT ID: NCT05467553 Not yet recruiting - Hepatitis D Clinical Trials

A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection

Start date: February 24, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label, randomized, multi-center study in patients with chronic HBV and HDV co-infection.

NCT ID: NCT05461170 Recruiting - Clinical trials for Hepatitis D, Chronic

SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

Start date: September 17, 2022
Phase: Phase 2
Study type: Interventional

This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy

NCT ID: NCT05451082 Not yet recruiting - Hepatitis D Clinical Trials

Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China

Start date: July 2022
Phase:
Study type: Observational

This is a retrospective, prospective, noninterventive, multicenter registry study. Patients diagnosed with HDV infection (based on positive HDV RNA) were included in this study and were followed up for at least 5 years to evaluate their disease progression and clinical outcomes (including death, liver transplantation, hepatocellular carcinoma [hcc], liver decompensation, and cirrhosis) during the 5-year follow-up period. All patients were followed up at least once a year after they were included in the study. It was in 2016 HDV infection first reported in China. Since January 1, 2016, all patients diagnosed with HDV infection can be enrolled in this study and evidence confirming the diagnosis (including but not limited to HDV RNA test reports and medical records, etc.) must be delivered. The main test results (including serum HDV RNA, ALT, and tests to determine the presence of liver cirrhosis, decompensation of liver function, and liver cancer such as B-ultrasound and FibroScan) of these patients each year from diagnosis to enrollment should be collected and filled in the case report form (CRF). Follow-up data of patients with serum anti-HDV positive and HDV RNA negative can be recorded and followed up on this platform, with informed consent of the patients is required. Patients whose serum HBV RNA turn positive during the follow-up period will be included in the follow-up cohort of the study.

NCT ID: NCT05394623 Not yet recruiting - Hepatitis B Clinical Trials

Prevalence and Burden of Hepatitis D Virus Infection in China Through Preoperative Examination Test (Predict Study)

Start date: November 1, 2022
Phase:
Study type: Observational

In China, there is no recommendation for Hepatitis D virus (HDV) screening, but the fact is estimated that one-third of the world's population of individuals with chronic Hepatitis B virus (HBV) infection live in China while we do not know the prevalence of co-infection of HBV/HDV in China. So far, no nationwide study has been undertaken to evaluate the epidemiology of hepatitis D, on the other hand, reports of HDV infection rate in different regions of China are not consistent because of the different detection methods and detection objects. Here, we plan to test HDV-Ab/RNA for 5000 HBsAg reactive samples from 10 major tertiary hospital and to know the prevalence and disease burden of HDV in China.

NCT ID: NCT05264272 Recruiting - Chronic Hepatitis B Clinical Trials

Disease Loads and Status of Treatment

Start date: January 1, 2022
Phase:
Study type: Observational

The aim of study is to evaluate the current prevalence of HDV infection, and comprehensively analyze the interaction between HDV and HBV infections in the era of NAs in Taiwan. Investigators plan to set up a platform for HDV positive patients in Taiwan to invite sites or hepatologists who are interested in this field.

NCT ID: NCT05229991 Active, not recruiting - Clinical trials for Hepatitis D, Chronic

Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis D Virus Infection

LOWR6
Start date: May 15, 2021
Phase: Phase 3
Study type: Interventional

Open label, single arm, multi-center clinical trial of lonafarnib 50 mg QD plus ritonavir 200 mg QD, administered orally, over a 48-week treatment period, with a 24-week post-treatment follow-up period, in patients with chronic Hepatitis D Virusinfection. Objectives: To evaluate the safety and tolerability of once daily dosing of lonafarnib 50 mg with ritonavir 200 mg over a 48-week treatment period. To evaluate the effect of once daily dosing of lonafarnib 50 mg with ritonavir 200 mg over a 48-week treatment period with a 24-week post-treatment follow-up on HDV viral levels. Trial population: Up to 30 patients with chronic HDV infection with detectable HDV RNA and compensated liver disease.

NCT ID: NCT05181956 Not yet recruiting - Clinical trials for Chronic Hepatitis D Infection With Hepatitis B

Testing and Epidemiology of Delta Hepatitis

Start date: January 3, 2022
Phase:
Study type: Observational

Study is to 1. Understand the pattern of hepatitis delta screening among medical providers for Asian patients with chronic hepatitis B 2. Determine the proportion of Asian hepatitis B patients who have been screened and who have chronic hepatitis delta 3. Determine the pattern of hepatitis delta screening after education of medical providers on hepatitis delta