Hepatitis BNCT03248622
Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection
An observational study of Hepatitis B, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Treatment of some diseases can suppress the immune system. This can cause other conditions to reactivate. Recent cases have shown that hepatitis B virus (HBV) reactivates in people who had already recovered from it during treatment for chronic hepatitis C (CHC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2017to 28 May 2019
- 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 hepatitis C who were anti-HBc positive and who received treatment with a direct acting antiviral agent.
Who may be able to join
- Adult patients (greater than or equal to 18 years) with CHC who underwent treatment with an Interferon-free DAA-based therapy.
- Evidence of resolved HBV infection prior to starting interferon-free DAAbased therapy (HBsAg-negative with positive anti-HBc +/- positive anti-HBs)
Who cannot join
- Treatment with Nucleos(t)ide Analogues (NA) active against HBV prior to initiation of interferon-free DAA therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK)
Bethesda, Maryland, 20892
About this study
Background:
Treatment of some diseases can suppress the immune system. This can cause other conditions to reactivate. Recent cases have shown that hepatitis B virus (HBV) reactivates in people who had already recovered from it during treatment for chronic hepatitis C (CHC). Their treatment was direct-acting antiviral (DAA) agents. Researchers want to see how common this reactivation is. They want to learn what the effects are. They will study data that have already been collected.
Read more
Objectives:
To study HBV reactivation in people with CHC and resolved HBV infection who are being treated with interferon-free DAA-based therapy.
Eligibility:
Data were collected from adults 18 and older in studies that were done in 2012 and 2016.
Design:
Researchers will screen the records from the previous studies. They will identify participants who had HBV infection before they got DAA-based treatment.
Researchers will take data from those records. This will include data on:
- Age, sex, race, and ethnicity
- Treatment and disease status
- Lab results
Researchers will test stored samples. They will test samples that were taken before, during, and after treatment. They will check if HBV was reactivated. They will also check if other clinical outcomes occurred.
Read the detailed description
Reactivation of hepatitis B is well known to occur with immunosuppression as in the setting of high dose immunosuppressive therapy, cancer chemotherapy and bone marrow or stem cell transplantation. It is usually subclinical but at times can manifest as an acute hepatitis, hepatic decompensation and death. Often times this leads to interruption of cancer chemotherapy.
Recently, several case reports and case series have revealed evidence of hepatitis B virus (HBV) reactivation in previously recovered persons being treated for chronic hepatitis C (CHC) with direct-acting antiviral (DAA) agents. Given the severity of some cases, the U.S. Food and Drug Administration (FDA) has issued a Black Box warning regarding the risk of HBV reactivation to HCV DAA labeling to screen all hepatitis C patients for HBV before initiation of therapy and to monitor those with previous HBV infection for signs of reactivation while on treatment. However, since the FDA warning, retrospective experiences on clinical trials have failed to reveal evidence of viral reactivation. Further, the frequency of HBV reactivation and its risk factors and monitoring frequency in HCV patients receiving Interferon-free DAA therapy are yet unknown. Hence, we aim to conduct a multicenter retrospective analysis to investigate these issues.
- Conditions
- Hepatitis B
- Keywords
- Incidence, Hepatitis B Surface Antigen, Decompensation
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anti-HBc positive | Anti-HBc positive | |
| HCV positive Cohort | HCV positive Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of HBV reactivation among patient with resolved HBV infection undergoing Interferon-free DAA-based therapy for HCV infection.
Detection of HBV DNA or HBsAg and elevated ALT level
Measured: From initiation of treatment to 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start3 Jun 2017
- Primary completion28 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marc G Ghany, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248622
- Sponsor's protocol ID
- 999917099
- Other IDs
- 17-DK-N099
- Status last verified
- Nov 2023
- First submitted
- 11 Aug 2017
- Last updated
- 30 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT03248622
- Acronym / sponsor ID
- 999917099
- Conditions
- Hepatitis B
- Keywords
- Incidence, Hepatitis B Surface Antigen, Decompensation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 3 Jun 2017 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 14 Aug 2017 (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.
Background:
Treatment of some diseases can suppress the immune system. This can cause other conditions to reactivate. Recent cases have shown that hepatitis B virus (HBV) reactivates in people who had already recovered from it during treatment for chronic hepatitis C (CHC). Their treatment was direct-acting antiviral (DAA) agents. Researchers want to see how common this reactivation is. They want to learn what the effects are. They will study data that have already been collected.
Objectives:
To study HBV reactivation in people with CHC and resolved HBV infection who are being treated with interferon-free DAA-based therapy.
Eligibility:
Data were collected from adults 18 and older in studies that were done in 2012 and 2016.
Design:
Researchers will screen the records from the previous studies. They will identify participants who had HBV infection before they got DAA-based treatment.
Researchers will take data from those records. This will include data on:
- Age, sex, race, and ethnicity
- Treatment and disease status
- Lab results
Researchers will test stored samples. They will test samples that were taken before, during, and after treatment. They will check if HBV was reactivated. They will also check if other clinical outcomes occurred.
Detailed description
Reactivation of hepatitis B is well known to occur with immunosuppression as in the setting of high dose immunosuppressive therapy, cancer chemotherapy and bone marrow or stem cell transplantation. It is usually subclinical but at times can manifest as an acute hepatitis, hepatic decompensation and death. Often times this leads to interruption of cancer chemotherapy.
Recently, several case reports and case series have revealed evidence of hepatitis B virus (HBV) reactivation in previously recovered persons being treated for chronic hepatitis C (CHC) with direct-acting antiviral (DAA) agents. Given the severity of some cases, the U.S. Food and Drug Administration (FDA) has issued a Black Box warning regarding the risk of HBV reactivation to HCV DAA labeling to screen all hepatitis C patients for HBV before initiation of therapy and to monitor those with previous HBV infection for signs of reactivation while on treatment. However, since the FDA warning, retrospective experiences on clinical trials have failed to reveal evidence of viral reactivation. Further, the frequency of HBV reactivation and its risk factors and monitoring frequency in HCV patients receiving Interferon-free DAA therapy are yet unknown. Hence, we aim to conduct a multicenter retrospective analysis to investigate these issues.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-HBc positive | – | –Anti-HBc positive |
| HCV positive Cohort | – | –HCV positive Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatitis C who were anti-HBc positive and who received treatment with a direct acting antiviral agent.
Key inclusion criteria (2 listed)
- Adult patients (greater than or equal to 18 years) with CHC who underwent treatment with an Interferon-free DAA-based therapy.
- Evidence of resolved HBV infection prior to starting interferon-free DAAbased therapy (HBsAg-negative with positive anti-HBc +/- positive anti-HBs)
Key exclusion criteria (1 listed)
- Treatment with Nucleos(t)ide Analogues (NA) active against HBV prior to initiation of interferon-free DAA therapy
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
The rate of HBV reactivation among patient with resolved HBV infection undergoing Interferon-free DAA-based therapy for HCV infection.
Time frame: From initiation of treatment to 24 weeks post-treatment
Detection of HBV DNA or HBsAg and elevated ALT level
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 30 Nov 2023.
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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.
Marc G Ghany, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Hepatitis B, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 2 inclusion and 1 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 30 Nov 2023. 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 United States. 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?
The rate of HBV reactivation among patient with resolved HBV infection undergoing Interferon-free DAA-based therapy for HCV infection. (time frame: From initiation of treatment to 24 weeks post-treatment). 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 30 Nov 2023.