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Controlled Interruption of Nucleos(t)ide Analogue Treatment in Chronic Hepatitis B Infections
EU CTIS ID: 2024-511016-25-00
What this study is testing
Investigate the contribution of ethnicity to the off-treatment viral outcomes following controlled nucleos(t)ide analogue cessation in start of treatment HBeAg negative chronic hepatitis B infection.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- >= 18 years old <= 75 years old
- Chronic hepatitis B, defined as HBsAg positive or HBV DNA positive >= 6 months
- Start of NA-treatment HBeAg negative
- Under continuous NA treatment
- HBV DNA below the local limit of quantification for at least 36 months at cessatino or <= 2log IU/mL for at least 48 months at cessation
- ALT <= 2x Upper Limit Normal (40 U/L) on 2 sequential measurements at least 6 months apart (one of which is at screening)
You likely can't join if
- INR >1.3xULN (ULN = 1.1) (unless casued by anticoagulation therapy or vitamin K deficiency) at any point prior to or at the time of screening
- Pregancy or lactation
- Planned or recent (<6 months before inclusion) participation in other therapeutic interventional trials
- Ever receiving a HBV small interfering RNA (siRNA) investigational medicinal product
- Total bilirubin >1.2xULN (ULN = 1.2 mg/dL) (unless there is documentation of a benign cause such as Gilbert's disease) at any point prior to or at the time of screening
- Fibrosis >= F3 in most recent biopsy
See the full eligibility criteria
- >= 18 years old <= 75 years old
- Chronic hepatitis B, defined as HBsAg positive or HBV DNA positive >= 6 months
- Start of NA-treatment HBeAg negative
- Under continuous NA treatment
- HBV DNA below the local limit of quantification for at least 36 months at cessatino or <= 2log IU/mL for at least 48 months at cessation
- ALT <= 2x Upper Limit Normal (40 U/L) on 2 sequential measurements at least 6 months apart (one of which is at screening)
- INR >1.3xULN (ULN = 1.1) (unless casued by anticoagulation therapy or vitamin K deficiency) at any point prior to or at the time of screening
- Pregancy or lactation
- Planned or recent (<6 months before inclusion) participation in other therapeutic interventional trials
- Ever receiving a HBV small interfering RNA (siRNA) investigational medicinal product
- Total bilirubin >1.2xULN (ULN = 1.2 mg/dL) (unless there is documentation of a benign cause such as Gilbert's disease) at any point prior to or at the time of screening
- Fibrosis >= F3 in most recent biopsy
- Last Fibroscan result >9kPa and/or last ShearWave elastography (SWE) result >8.15 kPa. EASL clinical practice guidelines on non-invasive tests for liver fibrosis should be applied to determine the correctness and reliability of the elastography result, considering a max interquartile range/median of 30% and max ALT of 5xULN at elastography evaluation.
- Active confection: hepatitis C virus (HCV) RNA positive, hepatitis delta virus (HDV) RNA positive, human immunodeficiency virus (HIV) antigen (Ag)-Antibody (Ab) positive
- Extrahepatic manifestations of chronic hepatitis B. This includes: polyarteritis nodosa, glomerulonephritis, serum sickness-like prodrome, essential mixed cryoglobulinemia, dermatologic manifestations, arthritic manifestations and neurologic manifestations.
- Immunocompromised individuals (for definitions cfr. Study Protocol or the National Health Service (NHS) criteria)
- Patients that have either an antecedent of or ongoing HCC
- Patients with a family history of HCC despite compliance to standard of care follow-up
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.