Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
140
Countries
1
Sites
26
Chronic hepatitis B infection
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.
Key facts
- Sponsor
- Antwerp University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 15 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Fonds Wetenschappelijk Onderzoek Vlaanderen
External identifiers
- EU CT number
- 2024-511016-25-00
- EudraCT number
- 2021-001003-32
- ClinicalTrials.gov
- NCT04779970
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety
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.
Secondary objectives 2
- Compare the occurance of HBsAg loss at week 72 after treatment stop and the time for reaching HBsAg loss between the Caucasian patients and the non-Caucasian patients.
- Estimate the cost-effectiveness of treatment cessation and make long-term projections.
Conditions and MedDRA coding
Chronic hepatitis B infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10008910 | Chronic hepatitis B | 100000004862 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- >= 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)
Exclusion criteria 12
- 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
- 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
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 1
- The secondary endpoint of this study is HBsAg loss at week 72 after treatment cessation.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
Vemlidy 25 mg film-coated tablets
PRD4659207 · Product
- Active substance
- Tenofovir Alafenamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 42000 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF13 — -
- Marketing authorisation
- EU/1/16/1154/001
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tenofovir disoproxil Viatris 245 mg film-coated tablets
PRD11722241 · Product
- Active substance
- Tenofovir Disoproxil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 245 mg milligram(s)
- Max total dose
- 411600 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF07 — TENOFOVIR DISOPROXIL
- Marketing authorisation
- EU/1/16/1129/003
- MA holder
- VIATRIS LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Viread 245 mg film-coated tablets
PRD294997 · Product
- Active substance
- Tenofovir Disoproxil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 245 mg milligram(s)
- Max total dose
- 411600 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF07 — TENOFOVIR DISOPROXIL
- Marketing authorisation
- EU/1/01/200/001
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entecavir Krka 1 mg filmomhulde tabletten
PRD6449785 · Product
- Active substance
- Entecavir
- Substance synonyms
- 2-amino-9-((1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1680 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF10 — -
- Marketing authorisation
- RVG 119615
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tenofovir disoproxil Viatris 245 mg film-coated tablets
PRD11722242 · Product
- Active substance
- Tenofovir Disoproxil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 245 mg milligram(s)
- Max total dose
- 411600 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF07 — TENOFOVIR DISOPROXIL
- Marketing authorisation
- EU/1/16/1129/004
- MA holder
- VIATRIS LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Baraclude 0.5 mg film-coated tablets
PRD2333413 · Product
- Active substance
- Entecavir
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1680 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF10 — -
- Marketing authorisation
- EU/1/06/343/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Baraclude 1 mg film-coated tablets
PRD2333408 · Product
- Active substance
- Entecavir
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1680 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF10 — -
- Marketing authorisation
- EU/1/06/343/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entecavir Krka 0,5 mg filmomhulde tabletten
PRD6449784 · Product
- Active substance
- Entecavir
- Substance synonyms
- 2-amino-9-((1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1680 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF10 — -
- Marketing authorisation
- RVG 119614
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tenofovir disoproxil Viatris 245 mg film-coated tablets
PRD11722243 · Product
- Active substance
- Tenofovir Disoproxil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 245 mg milligram(s)
- Max total dose
- 411600 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF07 — TENOFOVIR DISOPROXIL
- Marketing authorisation
- EU/1/16/1129/005
- MA holder
- VIATRIS LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Viread 245 mg film-coated tablets
PRD294853 · Product
- Active substance
- Tenofovir Disoproxil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 245 mg milligram(s)
- Max total dose
- 411600 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF07 — TENOFOVIR DISOPROXIL
- Marketing authorisation
- EU/1/01/200/002
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Antwerp University Hospital
- Sponsor organisation
- Antwerp University Hospital
- Address
- Drie Eikenstraat 655
- City
- Edegem
- Postcode
- 2650
- Country
- Belgium
Scientific contact point
- Organisation
- Antwerp University Hospital
- Contact name
- Clinical Trial Center
Public contact point
- Organisation
- Antwerp University Hospital
- Contact name
- Clinical Trial Center
Locations
1 EU/EEA country · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 140 | 26 |
| Rest of world | — | 0 | — |
Investigational sites
UZ Leuven
Gastroenterology, Herestraat 49, 3000, Leuven
UZ Brussel
Gastroenterology, Laarbeeklaan 101, 1090, Jette
Hopital Erasme
Gastroenterology, Lennikse Baan 808, 1070, Anderlecht
Cliniques Universitaires Saint-Luc
Gastroenterology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre hospitalier universitaire de Liege
Gastroenterology, Avenue De L'Hopital 1, 4000, Liege
Ziekenhuis Aan De Stroom
Gastroenterology, Kempenstraat 100, 2030, Antwerp
Ziekenhuis Aan De Stroom
Gastroenterology, Oosterveldlaan 24, 2610, Antwerp
Ziekenhuis Oost Limburg
Gastroenterology, Synaps Park 1, 3600, Genk
Grand Hopital De Charleroi
Gastroenterology, Grand'rue 3, 6000, Charleroi
Algemeen Stedelijk Ziekenhuis Campus Aalst
Gastroenterology, Merestraat 80, 9300, Aalst
Vitaz
Gastroenterology, Moerlandstraat 1, 9100, Sint-Niklaas
Algemeen Ziekenhuis Delta
Gastroenterology, Deltalaan 1, 8800, Roeselare
Chu Brugmann
Gastroenterology, Arthur Van Gehuchtenplein 4, 1020, Brussels
Az St-Jan Brugge-Oostende A.V.
Gastroenterology, Ruddershove 10, 8000, Brugge
Algemeen Ziekenhuis Damiaan Oostende
Gastroenterology, Gouwelozestraat 100, 8400, Ostend
CHU Helora
Gastroenterology, Rue Ferrer 159 Boite 1, 7100, La Louviere
AZ Turnhout
Gastroenterology, Steenweg Op Merksplas 44, 2300, Turnhout
Az Maria Middelares Gent
Gastroenterology, Buitenring-Sint-Denijs 30, 9000, Gent
Algemeen Ziekenhuis Groeninge
Gastroenterology, President Kennedylaan 4, 8500, Kortrijk
Algemeen Ziekenhuis Klina
Gastroenterology, Augustijnslei 100, 2930, Brasschaat
Universitair Ziekenhuis Antwerpen
Gastroenterology, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Gastroenterology, Corneel Heymanslaan 10, 9000, Gent
Jessa Ziekenhuis
Gastroenterology, Salvatorstraat 20, 3500, Hasselt
CHC MontLegia
Gastroenterology, Boulev. De Patience Et Beajonc 2, 4000, Liege
CHU Saint Pierre
Gastroenterology, Hoogstraat 322, 1000, Brussels
Sante et Prevoyance
Gastroenterology, Rue Saint-Luc 8, 5004, Namur
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-01-15 | 2025-01-15 | 2025-04-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Pilot450_SM4_2021-001003-32_Protocol_v5_redacted_FOR PUBLICATION | 5.0 |
| Recruitment arrangements (for publication) | Pilot450_SM4_2021-001003-32_Planning_v4 | 4 |
| Subject information and informed consent form (for publication) | Pilot450_SM2_2021-001003-32_ICF_English_v2 | 2 |
| Subject information and informed consent form (for publication) | Pilot450_SM2_2021-001003-32_ICF_Francais_V2 | 2 |
| Subject information and informed consent form (for publication) | Pilot450_SM2_2021-001003-32_ICF_Nederlands_v2 | 2 |
| Subject information and informed consent form (for publication) | Pilot450_SM3_2021-001003-32_ICF_Chinese_v2 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Pilot450_2021-001003-32_SmPC-Baraclude | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Pilot450_2021-001003-32_SmPC-Entecavir KRKA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Pilot450_2021-001003-32_SmPC-TDF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Pilot450_2021-001003-32_SmPC-Vemlidy | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Pilot450_2021-001003-32_SmPC-Viread | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-06 | Belgium | Acceptable 2025-01-15
|
2025-01-15 |