View clinical trials related to Hepatitis D, Chronic.
Filter by:A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D
Background: Infection with hepatitis D virus leads to a chronic liver disease with no effective treatment. Lonafarnib has improved hepatitis D virus levels in blood, but the medication still needs more research. Ritonavir makes other drugs more effective and is used with lonafarnib to make it more effective. Lambda interferon stimulates the body s response to viruses. Researchers want to see if combining these drugs fights hepatitis D and helps the liver. Objectives: To see if combining lonafarnib, ritonavir, and lambda interferon is safe and effective to treat chronic hepatitis D infection. Eligibility: Adults at least 18 years old with chronic hepatitis D infection Design: Participants will be screened with a physical exam, medical history, and blood and urine tests. Throughout the study, all participants will: - Follow rules for medicine, food, and contraception - Take hepatitis B medicine - Have weight checked - Have routine blood and urine tests - Give stool samples - Female participants will have pregnancy tests. Participants will have 3 visits before treatment. They will repeat screening tests and have a heart test and liver scan. Participants will have a 5-day inpatient stay. They will: - Baseline blood and urine tests - Have eye tests - Answer health questions - Have a liver sample taken and liver blood pressure measured. Participants will be sedated. - Have reproductive tests - Start the study drugs and have blood draws Over 24 weeks of treatment, participants will: -Take 2 study drugs by mouth every day and 1 as a weekly injection
This is a multicenter, open-label, randomized clinical trial to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination with Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients with Chronic Hepatitis D
The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B / hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In this protocol, similar reduction/clearance of serum HBsAg and improved response to immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol was designed to include a 24 week follow-up period after treatment, however given the strong antiviral response against HBV and HDV infection in these patients, it is now important to extend the follow-up period in these patients to monitor over a longer period after treatment the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in the REP 301 protocol.
To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV patients.
This study will evaluate the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment will be followed by 24 weeks of treatment-free follow-up.
This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.
Randomized open-label substudy of daily Myrcludex B (MXB) plus pegylated interferon-alpha-2a (PEG-INF-a) in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B virus (HBV) co-infected with hepatitis delta virus (HDV).
A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of titrating-dose lonafarnib/ritonavir in patients chronically infected with hepatitis delta virus (HDV)
Background: - Chronic hepatitis D is a liver disease caused by the hepatitis D virus (HDV). It can be severe and progressive. Most people with hepatitis D will develop scarring and damage to the liver. There is no FDA approved drug to treat chronic hepatitis D. Researchers want to know if the drugs lonafarnib and ritonavir can help people with chronic hepatitis D. Objective: - To find out if treatment of hepatitis D with lonafarnib and ritonavir is safe and effective. Eligibility: - People 18 years of age and older with chronic hepatitis D. They must not have HIV or other major illnesses. Design: - Participants will be screened with medical history, physical exams, and blood tests. - Participants will have 24 weeks of treatment. They will then have 24 weeks of follow-up. - Participants will be in 1 of 6 treatment groups. Those in each group will receive different doses of the study drugs. Some groups will start with placebo but will receive treatment after 3 months of placebo. - Participants will also take drugs to treat hepatitis B. - Participants will have many visits. These will include: - One three-day stay at the Clinical Center - Physical exams - EKG: small sticky patches will be put on the chest, arms, and legs to trace heart rhythm - Ultrasounds of the abdomen - Urine and blood tests - Stool samples - Eye exams - Evaluations by a reproductive endocrinologist (women) or urologist (men). Men may provide a sperm sample (optional).