The purpose of this study is to assess the optimal dose of EBP921 by comparing the efficacy
and safety of 2 dose regimens in patients with chronic HDV.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01316185
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Men and women age 18 or older with the capacity to give written informed consent
Patients with compensated chronic HDV infection as indicated by presence of anti-HDV in serum.
Liver biopsy should be performed within one-year of study screening and graded using the Knodell scoring system.
Presence of HDV antigen in liver tissue or HDV-RNA in serum.
Active HBV replication will not exclude patients.
Previous therapy with standard alpha-interferon or peginterferon will not exclude patients.
Patients who are HBV therapy-naïve or who previously received HBV antiviral therapy will be eligible. Patients currently taking HBV antiviral therapy will e considered on a case basis.
Female subjects of reproductive potential and female partners of male subjects should be on two reliable forms of contraception from the start of the study until 60 days from the end of EBP921 dosing.
Severe neuropsychiatric disorders
History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease
Pregnant or breast-feeding patients or the inability to practice adequate contraception during the conduct of the study
Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.