Evidence map›Paper›PMID 36697207›Full record

Trial reportGut2023

Randomised phase 2 study (JADE) of the HBV capsid assembly modulator JNJ-56136379 with or without a nucleos(t)ide analogue in patients with chronic hepatitis B infection.

Harry L A Janssen, Jinlin Hou, Tarik Asselah, Henry L Y Chan, Fabien Zoulim, Yasuhito Tanaka, Ewa Janczewska, Ronald G Nahass, Stefan Bourgeois, Maria Buti and 9 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Gut, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03361956 (A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
11.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03361956 phase2completednot on this map

A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)Ide Analog in Subjects With Chronic Hepatitis B Virus Infection

TypeinterventionalSponsorJanssen Sciences Ireland UCRan2018 to 2020Enrolled232ConditionsHepatitis BArmsJNJ-56136379, Placebo, NA (ETV or TDF)
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Review
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  12. Article
  13. Targeting HBV with RNA interference: Paths to cure.Science translational medicine · 2025
    Review
  14. [Research progress on new drugs for the treatment of chronic hepatitis B virus infection].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Review
  15. Article
  16. Current and emerging strategies for the prevention of hepatocellular carcinoma.Nature reviews. Gastroenterology & hepatology · 2025
    Review
  17. Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 11 institutions in 11 countries.

Harry L A JanssenToronto General Hospital, Toronto, Ontario, Canada.
Jinlin HouNanfang Hospital, Southern Medical University, Guangzhou, China.ORCID 0000-0001-8230-8583
Tarik AsselahUniversité de Paris Cité, INSERM UMR1149, Hôpital Beaujon AP-HP, Clichy, France.ORCID 0000-0002-0024-0595
Henry L Y ChanThe Chinese University of Hong Kong, Hong Kong SAR, China.
Fabien ZoulimHospices Civils de Lyon and Lyon University & INSERM U1052-Cancer Research Institute of Lyon, Lyon, France.ORCID 0000-0002-2245-0083
Yasuhito TanakaDepartment of Gastroenterology and Hepatology, Kumamoto University, Kumamoto, Japan.
Ewa JanczewskaFaculty of Health Sciences in Bytom, Medical University of Silesia, Katowice, Poland.
Ronald G NahassID Care, Hillsborough, New Jersey, USA.
Stefan BourgeoisZNA Jan Palfijn, CPU, Antwerp, Belgium.
Maria ButiHospital Universitario Vall d'Hebrón and CIBERHED del Instituto Carlos III, Barcelona, Spain.
Pietro LamperticoDivision of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID 0000-0002-1026-7476
Oliver LenzJanssen Pharmaceutica NV, Beerse, Belgium.
Thierry VerbinnenJanssen Pharmaceutica NV, Beerse, Belgium.
Joris VandenbosscheJanssen Pharmaceutica NV, Beerse, Belgium.
Willem TalloenJanssen Pharmaceutica NV, Beerse, Belgium.
Ronald KalmeijerJanssen Pharmaceuticals R&D, Titusville, New Jersey, USA.
Maria BeumontJanssen Pharmaceuticals R&D, Titusville, New Jersey, USA.
Michael BiermerJanssen Pharmaceutica NV, Beerse, Belgium mbiermer@its.jnj.com.ORCID 0000-0001-6993-8206
Umesh ShuklaJanssen Pharmaceuticals R&D, Titusville, New Jersey, USA.
Janssen (Belgium) · BEJanssen (United States) · USInserm · FRChinese University of Hong Kong · HKKumamoto University · JPMedical University of Silesia · PLNanfang Hospital · CNToronto General Hospital · CAUniversity of Antwerp · BEUniversity of Milan · ITVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe present the final analysis results of the phase 2 JADE study (ClinicalTrials.gov Identifier: NCT03361956).

design232 patients with chronic hepatitis B (CHB) not currently treated at study start (NCT) at study start or virologically suppressed were randomised to receive 75 mg (part 1) or 250 mg (part 2) JNJ-56136379, a hepatitis B virus (HBV)-capsid assembly modulator, one time per day or placebo with nucleos(t)ide analogue (NA) (tenofovir disoproxil fumarate/entecavir) or JNJ-56136379 alone (NCT-only) for ≥24 and ≤48 weeks.

resultsIn patients who are NCT hepatitis B e-antigen (HBeAg) positive, JNJ-56136379 75 mg+NA and 250 mg+NA showed limited mean (SE) hepatitis B surface antigen (HBsAg) declines (0.14 (0.10) and 0.41 (0.15), respectively) from baseline at Week 24 (primary endpoint; placebo+NA: 0.25 (0.11) log

conclusionsIn patients with non-cirrhotic CHB, JNJ-56136379+NA showed pronounced reductions in HBV DNA and HBV RNA, limited HBsAg or HBeAg declines in patients who are NCT HBeAg positive, and was well tolerated, but no clear benefit with regards to efficacy of JNJ-56136379 over NA was observed.

Indexed as

Hepatitis BHepatitis B, ChronicAntiviral AgentsCapsidDNA, ViralHepatitis B Core AntigensHepatitis B e AntigensHepatitis B Surface AntigensHepatitis B virusHumansOrganic ChemicalsTreatment OutcomeAntiviral AgentsDNA, ViralHepatitis B Core AntigensHepatitis B e AntigensHepatitis B Surface AntigensJNJ-56136379Organic ChemicalsCHRONIC HEPATITISCLINICAL TRIALSHEPATITIS B

Identifiers

PMID36697207
PMCPMC10313999
OpenAlexW4318003461

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.