Chronic Hepatitis DNCT06121427
Incidence of Viral Hepatitis D Relapses Upon Discontinuation of Bulevirtide in Patients With Chronic Hepatitis D and Negative HDV RNA
An observational study of Chronic Hepatitis D, run by Center of target therapy at 1 site in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis D
- How many people
- 24 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic co-infection with hepatitis B and D viruses with negative PCR HDV RNA who meet inclusion/exclusion criteria
Who may be able to join
- Informed consent of the patient to participate in the study, collect and use data
- Age 18 or older
- Background therapy with bulevirtide for at least 48 weeks
- Negative qualitative PCR test for RNA of viral hepatitis D in peripheral blood before inclusion in the study
- No active liver inflammation
- Liver biopsy performed as part of routine practice (no older than 3 weeks before inclusion in the study) or prescribed biopsy to be performed before bulevirtide interruption
Who cannot join
- Liver damage not related to viral hepatitis B and D - autoimmune hepatitis, drug or alcohol liver damage, Wilson-Konovalov disease, etc.
- Co-infection with hepatitis C virus
- Patients receiving HBV and HDV therapy not in accordance with standard practice or violations of the Instructions for the medical use of the drug/s
- Moderate/severe renal/liver dysfunction
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational Clinical Study to Evaluate the Incidence of Viral Hepatitis D Relapses Upon Discontinuation of Antiviral Therapy With Bulevirtide in Patients With Chronic Hepatitis D and Negative HDV RNA
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.
Read the detailed description
The main goal of this study is the following:
- To assess the probability of HDV relapse-free over time after discontinuation of background therapy with bulevirtide in patients with chronic co-infection with hepatitis B and D viruses and negative PCR HDV RNA
Primary endpoint: Occurrence of hepatitis D viral relapse.
Additional objectives in this study:
- Analyze data on the time of relapse and the duration of previous background therapy with bulevirtide, the duration of the period of HDV suppression, and the use of any other concomitant antiviral therapy during the period of treatment with bulevirtide
- Analyze relapse-free patients over 96 weeks of study follow-up
- Analyze the results of qualitative PCR (positive / negative) for hepatitis D virus RNA in a liver biopsy before discontinuing bulevirtide therapy
- Conditions
- Chronic Hepatitis D
- Keywords
- bulevirtide
- Medical subject headings
- Hepatitis D, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 96 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 96 weeks
Relapse-free patients over 96 weeks
Analyze HDV relapse-free patients over 96 weeks
Measured: 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
Measured: Baseline (At the time of the patient inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Sep 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of target therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121427
- Sponsor's protocol ID
- CTT-001
- Status last verified
- Apr 2025
- First submitted
- 18 Oct 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Clinical Study to Evaluate the Incidence of Viral Hepatitis D Relapses Upon Discontinuation of Antiviral Therapy With Bulevirtide in Patients With Chronic Hepatitis D and Negative HDV RNA
- ClinicalTrials.gov ID
- NCT06121427
- Acronym / sponsor ID
- CTT-001
- Conditions
- Chronic Hepatitis D
- Keywords
- bulevirtide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Center of target therapyUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main goal of this study is the following:
- To assess the probability of HDV relapse-free over time after discontinuation of background therapy with bulevirtide in patients with chronic co-infection with hepatitis B and D viruses and negative PCR HDV RNA
Primary endpoint: Occurrence of hepatitis D viral relapse.
Additional objectives in this study:
- Analyze data on the time of relapse and the duration of previous background therapy with bulevirtide, the duration of the period of HDV suppression, and the use of any other concomitant antiviral therapy during the period of treatment with bulevirtide
- Analyze relapse-free patients over 96 weeks of study follow-up
- Analyze the results of qualitative PCR (positive / negative) for hepatitis D virus RNA in a liver biopsy before discontinuing bulevirtide therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic co-infection with hepatitis B and D viruses with negative PCR HDV RNA who meet inclusion/exclusion criteria
Key inclusion criteria (6 listed)
- Informed consent of the patient to participate in the study, collect and use data
- Age 18 or older
- Background therapy with bulevirtide for at least 48 weeks
- Negative qualitative PCR test for RNA of viral hepatitis D in peripheral blood before inclusion in the study
- No active liver inflammation
Key exclusion criteria (5 listed)
- Liver damage not related to viral hepatitis B and D - autoimmune hepatitis, drug or alcohol liver damage, Wilson-Konovalov disease, etc.
- Co-infection with hepatitis C virus
- Patients receiving HBV and HDV therapy not in accordance with standard practice or violations of the Instructions for the medical use of the drug/s
- Moderate/severe renal/liver dysfunction
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Probability of HDV relapse-free over time
Time frame: 96 weeks
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
5 secondary outcomes
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
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
Time frame: 96 weeks
Relapse-free patients over 96 weeks
Time frame: 96 weeks
Results of qualitative PCR HDV RNA in a liver biopsy
Time frame: Baseline (At the time of the patient inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis D, run by Center of target therapy at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of HDV relapse-free over time (time frame: 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.