An observational study in Chronic Hepatitis D, sponsored by Center of target therapy. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-25.
Sponsored by Center of target therapy · Observational
This observational study will be conducted in patients with chronic co-infection with hepatitis B and D viruses, with negative PCR for HDV RNA in peripheral blood and no signs of active liver inflammation according to blood chemistry parameters, receiving background therapy with bulevirtide for more than 48 weeks and liver biopsy performed or prescribed to be performed as part of routine practice.
After the patient has signed the Informed Consent, a portion of the liver biopsy collected as part of routine practice will be sent to the laboratory for PCR testing for HDV RNA, background therapy with bulevirtide will be interrupted, and the patient will be observed in the clinic in accordance with routine medical practice, but at least once times every 4 weeks, for timely detection of relapse of the hepatitis D and initiation of antiviral therapy. Once a relapse of viral hepatitis D is determined via the PCR HDV RNA, the patient's participation in the study will be terminated.
The collected data will be analyzed to assess the probability of relapse-free over time. Separate tests will also be conducted for subgroups of patients based on covariates such as duration of previous background therapy with bulevirtide, duration of HDV suppression, use of any other concomitant antiviral therapy during bulevirtide treatment.
The main goal of this study is the following:
Primary endpoint: Occurrence of hepatitis D viral relapse.
Additional objectives in this study:
43 studies on the registry are indexed under Hepatitis D, Chronic; 9 are open to participants now.
This study's enrollment of 24 is below the median of 285 across 10 observational studies indexed under Hepatitis D, Chronic.
Browse Hepatitis D, Chronic studies →Center of target therapy is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with chronic co-infection with hepatitis B and D viruses with negative PCR HDV RNA who meet inclusion/exclusion criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Probability of HDV relapse-free over time
To assess the probability of HDV relapse-free over time discontinuation of background therapy with bulevirtide in patients with chronic co-infection with hepatitis B and D viruses and negative PCR HDV RNA
Time frame: 96 weeks
Probability of HDV relapse-free over time and the duration of previous background therapy with boulevertide
Analyze the probability of HDV relapse-free over time and the duration of previous background therapy with boulevertide
Time frame: 96 weeks
Probability of HDV relapse-free over time and the duration of the period of HDV suppression
Analyze the probability of HDV relapse-free over time and the duration of the period of HDV suppression
Time frame: 96 weeks
Probability of HDV relapse-free over time and the use of any other concomitant antiviral therapy during the period of treatment with bulevirtide
Analyze the probability of HDV relapse-free over time and the use of any other concomitant antiviral therapy during the period of treatment with bulevirtide
Time frame: 96 weeks
Relapse-free patients over 96 weeks
Analyze HDV relapse-free patients over 96 weeks
Time frame: 96 weeks
Results of qualitative PCR HDV RNA in a liver biopsy
Analyze the results of qualitative PCR HDV RNA (positive / negative) in a liver biopsy before discontinuing bulevirtide therapy
Time frame: Baseline (At the time of the patient inclusion)
Plan to share: No
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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