Clinical trial • Phase IV • Infectious Disease
TENOFOVIR ALAFENAMIDE for Chronic hepatitis B
Phase IV trial of TENOFOVIR ALAFENAMIDE for Chronic hepatitis B. 140 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Chronic hepatitis B
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 06-01-2025
- First CTIS Authorization Date
- 15-01-2025
Trial design
Phase IV trial across 26 sites in Belgium.
- Target Sample Size
- 140
- Trial Duration For Participant
- 504
Eligibility
Recruits 140 No vulnerable populations selected. The trial enrols adults (>= 18 years). Informed consent is required from participants (no assent process specified). Subject information and informed consent forms are provided in English, Français (French), Nederlands (Dutch) and Chinese..
- Pregnancy Exclusion
- Pregancy or lactation
- Vulnerable Population
- No vulnerable populations selected. The trial enrols adults (>= 18 years). Informed consent is required from participants (no assent process specified). Subject information and informed consent forms are provided in English, Français (French), Nederlands (Dutch) and Chinese.
Inclusion criteria
- {"criterion_text":"- >= 18 years old <= 75 years old"}
- {"criterion_text":"- Chronic hepatitis B, defined as HBsAg positive or HBV DNA positive >= 6 months"}
- {"criterion_text":"- Start of NA-treatment HBeAg negative"}
- {"criterion_text":"- Under continuous NA treatment"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- ALT <= 2x Upper Limit Normal (40 U/L) on 2 sequential measurements at least 6 months apart (one of which is at screening)"}
Exclusion criteria
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Fibrosis >= F3 in most recent biopsy"}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Active confection: hepatitis C virus (HCV) RNA positive, hepatitis delta virus (HDV) RNA positive, human immunodeficiency virus (HIV) antigen (Ag)-Antibody (Ab) positive"}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Immunocompromised individuals (for definitions cfr. Study Protocol or the National Health Service (NHS) criteria)"}
- {"criterion_text":"- Patients that have either an antecedent of or ongoing HCC"}
- {"criterion_text":"- Patients with a family history of HCC despite compliance to standard of care follow-up"}
- {"criterion_text":"- Pregancy or lactation"}
- {"criterion_text":"- Planned or recent (<6 months before inclusion) participation in other therapeutic interventional trials"}
- {"criterion_text":"- Ever receiving a HBV small interfering RNA (siRNA) investigational medicinal product"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint of this study is the occurrence of viral control defined as HBV DNA ≤2000 IU/mL and ALT ≤2xULN 72 weeks after treatment cessation.","definition_or_measurement_approach":"Viral control defined as HBV DNA ≤2000 IU/mL and ALT ≤2xULN measured at 72 weeks after treatment cessation."}
Secondary endpoints
- {"endpoint_text":"- The secondary endpoint of this study is HBsAg loss at week 72 after treatment cessation.","definition_or_measurement_approach":"HBsAg loss measured at week 72 after treatment cessation."}
Recruitment
- Planned Sample Size
- 140
- Recruitment Window Months
- 14
- Consent Approach
- Informed consent obtained from adult participants (no assent described). Subject information and informed consent forms available in English, Français (French), Nederlands (Dutch) and Chinese.
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 140
Belgium
- Earliest CTIS Part Ii Submission Date
- 07-08-2024
- Latest Decision Or Authorization Date
- 15-01-2025
- Processing Time Days
- 161
- Number Of Sites
- 26
- Number Of Participants
- 140
Sites
- Site Name
- Hopital Erasme
- Department Name
- Gastroenterology
- Principal Investigator Name
- Christophe Moreno
- Principal Investigator Email
- christophe.moreno@erasme.ulb.ac.be
- Contact Person Name
- Christophe Moreno
- Contact Person Email
- christophe.moreno@erasme.ulb.ac.be
- Site Name
- UZ Brussel
- Department Name
- Gastroenterology
- Principal Investigator Name
- Hendrik Reynaert
- Principal Investigator Email
- hendrik.reynaert@uzbrussel.be
- Contact Person Name
- Hendrik Reynaert
- Contact Person Email
- hendrik.reynaert@uzbrussel.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Gastroenterology
- Principal Investigator Name
- Peter Stärkel
- Principal Investigator Email
- peter.starkel@saintluc.uclouvain.be
- Contact Person Name
- Peter Stärkel
- Contact Person Email
- peter.starkel@saintluc.uclouvain.be
- Site Name
- UZ Leuven
- Department Name
- Gastroenterology
- Principal Investigator Name
- Jef Verbeek
- Principal Investigator Email
- jef.verbeek@uzleuven.be
- Contact Person Name
- Jef Verbeek
- Contact Person Email
- jef.verbeek@uzleuven.be
- Site Name
- Vitaz
- Department Name
- Gastroenterology
- Principal Investigator Name
- Wim Verlinden
- Principal Investigator Email
- wim.verlinden@vitaz.be
- Contact Person Name
- Wim Verlinden
- Contact Person Email
- wim.verlinden@vitaz.be
- Site Name
- Sante et Prevoyance
- Department Name
- Gastroenterology
- Principal Investigator Name
- Pierre Deltenre
- Principal Investigator Email
- pierre.deltenre@slbo.be
- Contact Person Name
- Pierre Deltenre
- Contact Person Email
- pierre.deltenre@slbo.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Gastroenterology
- Principal Investigator Name
- Jean Delwaide
- Principal Investigator Email
- jean.delwaide@chuliege.be
- Contact Person Name
- Jean Delwaide
- Contact Person Email
- jean.delwaide@chuliege.be
- Site Name
- Chu Brugmann
- Department Name
- Gastroenterology
- Principal Investigator Name
- Baro Deressa
- Principal Investigator Email
- baro.deressa@chu-brugmann.be
- Contact Person Name
- Baro Deressa
- Contact Person Email
- baro.deressa@chu-brugmann.be
- Site Name
- Ziekenhuis Aan De Stroom
- Department Name
- Gastroenterology
- Principal Investigator Name
- Dirk Sprengers
- Principal Investigator Email
- dirk.sprengers@zas.be
- Contact Person Name
- Dirk Sprengers
- Contact Person Email
- dirk.sprengers@zas.be
- Site Name
- CHU Saint Pierre
- Department Name
- Gastroenterology
- Principal Investigator Name
- Jean-Pierre Mulkay
- Principal Investigator Email
- jean-pierre.mulkay@stpierre-bru.be
- Contact Person Name
- Jean-Pierre Mulkay
- Contact Person Email
- jean-pierre.mulkay@stpierre-bru.be
- Site Name
- CHC MontLegia
- Department Name
- Gastroenterology
- Principal Investigator Name
- Boris Bastens
- Principal Investigator Email
- boris.bastens@chc.be
- Contact Person Name
- Boris Bastens
- Contact Person Email
- boris.bastens@chc.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Gastroenterology
- Principal Investigator Name
- Charlotte De Vloo
- Principal Investigator Email
- charlotte.devloo@azdelta.be
- Contact Person Name
- Charlotte De Vloo
- Contact Person Email
- charlotte.devloo@azdelta.be
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Hans Orlent
- Principal Investigator Email
- hans.orlent@azsintjan.be
- Contact Person Name
- Hans Orlent
- Contact Person Email
- hans.orlent@azsintjan.be
- Site Name
- AZ Turnhout
- Department Name
- Gastroenterology
- Principal Investigator Name
- Guy Van Roey
- Principal Investigator Email
- guy.vanroey@azturnhout.be
- Contact Person Name
- Guy Van Roey
- Contact Person Email
- guy.vanroey@azturnhout.be
- Site Name
- CHU Helora
- Department Name
- Gastroenterology
- Principal Investigator Name
- Marie de Vos
- Principal Investigator Email
- marie.devo@jolimont.be
- Contact Person Name
- Marie de Vos
- Contact Person Email
- marie.devo@jolimont.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Gastroenterology
- Principal Investigator Name
- Xavier Verhelst
- Principal Investigator Email
- xavier.verhelst@uzgent.be
- Contact Person Name
- Xavier Verhelst
- Contact Person Email
- xavier.verhelst@uzgent.be
- Site Name
- Algemeen Ziekenhuis Klina
- Department Name
- Gastroenterology
- Principal Investigator Name
- Jos Callens
- Principal Investigator Email
- jos.calles@azklina.be
- Contact Person Name
- Jos Callens
- Contact Person Email
- jos.calles@azklina.be
- Site Name
- Algemeen Stedelijk Ziekenhuis Campus Aalst
- Department Name
- Gastroenterology
- Principal Investigator Name
- Isabelle Colle
- Principal Investigator Email
- isabelle.colle@asz.be
- Contact Person Name
- Isabelle Colle
- Contact Person Email
- isabelle.colle@asz.be
- Site Name
- Ziekenhuis Aan De Stroom
- Department Name
- Gastroenterology
- Principal Investigator Name
- Stefan Bourgeois
- Principal Investigator Email
- stefan.bourgeois@zas.be
- Contact Person Name
- Stefan Bourgeois
- Contact Person Email
- stefan.bourgeois@zas.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Gastroenterology
- Principal Investigator Name
- Thomas Vanwolleghem
- Principal Investigator Email
- thomas.vanwolleghem@uza.be
- Contact Person Name
- Thomas Vanwolleghem
- Contact Person Email
- thomas.vanwolleghem@uza.be
- Site Name
- Az Maria Middelares Gent
- Department Name
- Gastroenterology
- Principal Investigator Name
- Christophe Van Steenkiste
- Principal Investigator Email
- christohpe.vansteenkiste@azmmsj.be
- Contact Person Name
- Christophe Van Steenkiste
- Contact Person Email
- christohpe.vansteenkiste@azmmsj.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Gastroenterology
- Principal Investigator Name
- Filip Janssens
- Principal Investigator Email
- filip.janssens@jessazh.be
- Contact Person Name
- Filip Janssens
- Contact Person Email
- filip.janssens@jessazh.be
- Site Name
- Ziekenhuis Oost Limburg
- Department Name
- Gastroenterology
- Principal Investigator Name
- Mathieu Struyve
- Principal Investigator Email
- mathieu.struyve@zol.be
- Contact Person Name
- Mathieu Struyve
- Contact Person Email
- mathieu.struyve@zol.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Gastroenterology
- Principal Investigator Name
- Christophe George
- Principal Investigator Email
- christophe.george@azgroeninge.be
- Contact Person Name
- Christophe George
- Contact Person Email
- christophe.george@azgroeninge.be
- Site Name
- Grand Hopital De Charleroi
- Department Name
- Gastroenterology
- Principal Investigator Name
- Sergio Negrin-Dastis
- Principal Investigator Email
- sergio.negrindastis@ghdc.be
- Contact Person Name
- Sergio Negrin-Dastis
- Contact Person Email
- sergio.negrindastis@ghdc.be
- Site Name
- Algemeen Ziekenhuis Damiaan Oostende
- Department Name
- Gastroenterology
- Principal Investigator Name
- Mike Cool
- Principal Investigator Email
- mcool@azdamiaan.be
- Contact Person Name
- Mike Cool
- Contact Person Email
- mcool@azdamiaan.be
Sponsor
Primary sponsor
- Full Name
- Antwerp University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Vemlidy 25 mg film-coated tablets
- Active Substance
- TENOFOVIR ALAFENAMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation: EU/1/16/1154/001
- Starting Dose
- 25 mg
- Maximum Dose
- 25 mg
- Investigational Product Name
- Tenofovir disoproxil Viatris 245 mg film-coated tablets
- Active Substance
- TENOFOVIR DISOPROXIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation: EU/1/16/1129/003
- Starting Dose
- 245 mg
- Maximum Dose
- 245 mg
- Investigational Product Name
- Viread 245 mg film-coated tablets
- Active Substance
- TENOFOVIR DISOPROXIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation: EU/1/01/200/002
- Starting Dose
- 245 mg
- Maximum Dose
- 245 mg
- Investigational Product Name
- Baraclude 1 mg film-coated tablets
- Active Substance
- ENTECAVIR
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation: EU/1/06/343/002
- Starting Dose
- 1 mg
- Maximum Dose
- 1 mg
- Investigational Product Name
- Baraclude 0.5 mg film-coated tablets
- Active Substance
- ENTECAVIR
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Starting Dose
- 0.5 mg
- Maximum Dose
- 1 mg
- Investigational Product Name
- Entecavir Krka 1 mg filmomhulde tabletten
- Active Substance
- ENTECAVIR
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation: RVG 119615
- Starting Dose
- 1 mg
- Maximum Dose
- 1 mg
- Investigational Product Name
- Entecavir Krka 0,5 mg filmomhulde tabletten
- Active Substance
- ENTECAVIR
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation: RVG 119614
- Starting Dose
- 0.5 mg
- Maximum Dose
- 1 mg
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