A Clinical Study to Investigate the Efficacy and Safety of JNJ-73763989 + Nucleos(t)ide Analog in Participants Co-infected with Hepatitis B and Hepatitis D Virus

2023-506763-33-00 Therapeutic exploratory (Phase II) Ended

Start 18 Dec 2020 · End 5 Mar 2025 · Status Ended · 3 EU/EEA countries · 6 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 46
Countries 3
Sites 6

Hepatitis B and Hepatitis D Viral Co-infection

To evaluate on-treatment efficacy against HDV of JNJ-3989 + NA regimen compared to NA alone.

Key facts

Sponsor
Janssen - Cilag International
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Virus Diseases [C02]
Trial duration
18 Dec 2020 → 5 Mar 2025
Decision date (initial)
2024-02-08
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Janssen Research and Development LLC

External identifiers

EU CT number
2023-506763-33-00
EudraCT number
2020-001249-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Therapy, Safety

To evaluate on-treatment efficacy against HDV of JNJ-3989 + NA regimen compared to NA alone.

Conditions and MedDRA coding

Hepatitis B and Hepatitis D Viral Co-infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Male or female (according to their reproductive organs and functions assigned by chromosomal complement).
  2. 18 (or the legal age of consent in the jurisdiction in which the study is taking place provided that the legal age of consent is ≥18 years) to 65 years of age, inclusive.
  3. Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening.
  4. Must have: - chronic hepatitis B infection either HBeAg positive or HBeAg negative and either receiving NA treatment or no NA treatment. Chronic HBV infection documented by serum HBsAg positivity at screening. - chronic HDV infection documented by positive HDV antibodies or HDV RNA at screening.
  5. For Part 1: must have HDV RNA values at screening ≥1,000 IU/mL. For Part 2: must have HDV RNA values at screening ≥500 IU/mL, and must have HBsAg values at screening ≤10,000 IU/mL.

Exclusion criteria 5

  1. Participants with evidence of hepatitis A virus infection, hepatitis C virus infection, or hepatitis E virus infection, or human immunodeficiency virus type 1 or type 2 infection (confirmed by antibodies) at screening.
  2. Any of the following laboratory abnormalities within 12 months prior to screening or at time of screening: a. Total bilirubin >1.7x ULN, b. Direct bilirubin >1.4x ULN, c. Prothrombin time >1.3x ULN, d. Serum albumin <3.2 g/dL.
  3. History or evidence of clinical signs/symptoms of hepatic decompensation.
  4. Child-Pugh score B or C at screening (Part 1) and liver cirrhosis at screening (Part 2).
  5. Evidence of liver disease of non-HDV or non-HBV etiology.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Proportion of participants with HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT levels at Week 48.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Emtricitabine

SCP12506478 · ATC

Active substance
Emtricitabine
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
204 Week(s)
Authorisation status
Authorised
ATC code
J05AF07 — TENOFOVIR DISOPROXIL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tenofovir Alafenamide

SCP17542550 · ATC

Active substance
Tenofovir Alafenamide
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
204 Week(s)
Authorisation status
Authorised
ATC code
J05AF13 — TENOFOVIR ALAFENAMIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Entecavir

SCP25844199 · ATC

Active substance
Entecavir
Substance synonyms
2-amino-9-((1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
204 Week(s)
Authorisation status
Authorised
ATC code
J05AF10 — ENTECAVIR
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

JNJ-73763989

PRD10882388 · Product

Active substance
Daplusiran
Substance synonyms
JNJ-73763976
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg/ml milligram(s)/millilitre
Max treatment duration
204 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Placebo 1

Sodium chloride solution 0.9%

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

109 Total trials 22 Recruiting 86 Ended
Commercial
Sponsor organisation
Janssen - Cilag International
Address
Turnhoutseweg 30
City
Beerse
Postcode
2340
Country
Belgium

Scientific contact point

Organisation
Janssen - Cilag International
Contact name
CTIS Point of Contact

Public contact point

Organisation
Janssen - Cilag International
Contact name
CTIS Point of Contact

Third parties 15

OrganisationCity, countryDuties
Axolabs GmbH
ORG-100043876
 Kulmbach, Germany Other, Laboratory analysis
Cedars Sinai Medical Center
ORG-100032403
 Los Angeles, United States Other
Stichting EuroQol Research Foundation
ORG-100048809
 Rotterdam, Netherlands Other
Labcorp Central Laboratory Services S.a.r.l.
ORG-100011524
 Meyrin, Switzerland Laboratory analysis
Clinigen Clinical Supplies Management
ORG-100034422
 Mont-Saint-Guibert, Belgium Laboratory analysis
Parexel International Romania S.R.L.
ORG-100029949
 Bucharest, Romania Data management
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Acolad Life Sciences LLC
ORG-100049731
 Westminster, United States Other
Signant Health Global LLC
ORG-100040604
 Blue Bell, United States Interactive response technologies (IRT)
Universitair Ziekenhuis Gent
ORG-100021542
 Gent, Belgium Other, Laboratory analysis
DDL Diagnostic Laboratory B.V.
ORG-100046406
 Rijswijk Zh, Netherlands Other, Laboratory analysis
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States Code 13, E-data capture
Qd Solutions Inc.
ORG-100041849
 Austin, United States Other
Abf Pharmaceutical Services GmbH
ORG-100014752
 Vienna, Austria Other, Laboratory analysis
Qualitymetric Incorporated LLC
ORG-100044132
 Johnston, United States Other

Locations

3 EU/EEA countries · 6 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ended 2 2
Italy Ended 10 3
Sweden Ended 2 1
Rest of world
United States, United Kingdom, New Zealand, Taiwan, Turkey
 — 32 —

Investigational sites

France

2 sites · Ended
Centre Hospitalier Universitaire De Nantes
Infectious and tropical diseases, 1 Place Alexis Ricordeau, 44000, Nantes
Hopital Beaujon
Hepatology, 100 Boulevard Du General Leclerc, 92110, Clichy

Italy

3 sites · Ended
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
SC Gastroenterologia U, Corso Bramante 88, 10126, Turin
Universita' Degli Studi Di Roma La Sapienza
Dipartimento Medicina Interna, Scienze Endocrino-metaboliche e Malattie Infettive, Viale Dell'universita' 37, 00185, Rome
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
U. O. Gastroenterologia e Epatologia, Via Francesco Sforza 35, 20122, Milan

Sweden

1 site · Ended
Karolinska University Hospital
Medicinsk enhet Infektionssjukdomar, Halsovagen, Flemingsberg, Huddinge

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2022-05-20 2024-02-08 2022-08-01 2022-11-14
Italy 2022-03-04 2025-01-15 2022-05-03 2022-11-16
Sweden 2020-12-18 2024-07-22 2021-01-18 2022-05-19

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
73763989HPB2004 (CR108868)_Summary of Results
SUM-118499
 2026-02-09T18:13:28 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
73763989HPB2004_Lay Person Summary of Results 2026-02-09T18:14:40 Submitted Laypersons Summary of Results

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) 73763989HPB2004_PLS_16Sep2025_ESP_Spanish 1
Laypersons summary of results (for publication) 73763989HPB2004_PLS_16Sep2025_FRA_French 1
Laypersons summary of results (for publication) 73763989HPB2004_PLS_16Sep2025_GER_German 1
Laypersons summary of results (for publication) 73763989HPB2004_PLS_16Sep2025_ITA_Italian 1
Laypersons summary of results (for publication) 73763989HPB2004_PLS_16Sep2025_SWE_Swedish 1
Laypersons summary of results (for publication) 73763989HPB2004_PLS_16September2025 1
Protocol (for publication) D1_REDACTED Protocol 2023-506763-33 Am5
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Entecavir NA
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC TAF NA
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC TD NA
Summary of results (for publication) 73763989HPB2004_Summary of Results_CTIS Final Results submission_PDF_Aformat 17
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_FR_FR_2023-506763-33 6
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_IT_ITA_2023-506763-33 AM5
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_SE_Swe_2023-506763-33 AM5

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-12-18 Sweden Acceptable
2024-02-08
 2024-02-08
2 SUBSTANTIAL MODIFICATION SM-1 2024-05-09 Sweden Acceptable
2024-06-25
 2024-06-26
3 SUBSTANTIAL MODIFICATION SM-2 2024-07-17 Sweden Acceptable
2024-08-27
 2024-08-27

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