Clinical trial NCT04535544: A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis D, Chronic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-09-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.


Eligibility criteria: Inclusion Criteria:

* Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
* Chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) co-infection with documentation at least 6 months prior to screening
* For Part 1: hepatitis D RNA (HDV RNA) greater than or equal to (\>=) 1000 international units per milliliter (IU/mL) at screening. For Part 2: must have HDV RNA values \>= 500 IU/mL, and must have hepatitis B surface antigen (HBsAg) values less than or equal to (\<=) 10000 IU/mL at screening or HDV RNA values at screening are \<= 100000 IU/mL
* Alanine aminotransferase (ALT) greater than upper limit normal (ULN) but less than 10 times (ULN)
* Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m\^2), extremes included
* Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
* Non-cirrhotic participants and participants with compensated cirrhosis (Child Pugh class A) at screening (Part 1) and participants must have absence of cirrhosis and platelet count of \>= 140000 per deciliter (dL) for enrollment into Part-2

Exclusion Criteria:

* Evidence of infection with hepatitis A, C, or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
* History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol
* Evidence of liver disease of non-HBV/HDV etiology
* Signs of hepatocellular carcinoma (HCC)
* Significant laboratory abnormalities as defined in the protocol at screening
* Participants with a history of malignancy within 5 years before screening
* Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol
* History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease
* Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant
* History of or current clinically significant skin disease or drug rash
* Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 or its excipients or excipients of the placebo content
* Contraindications to the use of entecavir (ETV), tenofovir disoproxil, or tenofovir alafenamide (TAF) per local prescribing information
* Participants who have taken any therapies disallowed per protocol
* Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
* Male participants who plan to father a child while enrolled
* Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
* Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)

Primary outcomes:
measure: Double-blind: Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach)
timeFrame: At Week 48
measure: Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With ALT at Week 48 (Multiple Imputation Approach)
timeFrame: At Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University School of Medicine
state: California
city: Boston
country: United States
facility: Harvard Medical School Massachusetts General Hospital
state: Massachusetts
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Footscray
country: Australia
facility: Western Health
city: Westmead
country: Australia
facility: Westmead Hospital
city: Boa Vista
country: Brazil
facility: Centro Oncológico De Roraima
city: Manaus
country: Brazil
facility: Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado
city: Porto Velho
country: Brazil
facility: Cepem - Centro de Pesquisa Em Medicina Tropical
city: Beijing
country: China
facility: Beijing Ditan Hospital Capical Medical University
city: Beijing
country: China
facility: Peking University People s Hospital
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital, Guangzhou Medical University
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University College of Medicine
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Clichy
country: France
facility: Hopital Beaujon
city: Lyon
country: France
facility: Hopital de La Croix Rousse
city: Nantes
country: France
facility: CHU de Nantes hotel Dieu
city: Paris
country: France
facility: CHU Hopital Saint Antoine
city: Rennes
country: France
facility: Chu Rennes Hopital Pontchaillou
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Milano
country: Italy
facility: Irccs Ospedale Maggiore Di Milano
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Rome
country: Italy
facility: Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
city: Torino
country: Italy
facility: Ospedale Molinette, AO Città della Salute e della Scienza di
city: Bunkyo Ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
city: Iizuka-shi
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Ikeda
country: Japan
facility: Ikeda City Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagasaki
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
city: Nakagami gun
country: Japan
facility: University of the Ryukyus Hospital
city: Okinawa
country: Japan
facility: Nakagami Hospital
city: Suita-shi
country: Japan
facility: Osaka University Hospital
city: Suita
country: Japan
facility: Suita Municipal Hospital
city: Sumida ku
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis
city: Samara
country: Russian Federation
facility: Medical Company Hepatolog Ltd
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Danderyd
country: Sweden
facility: Danderyds Sjukhus
city: Malmö
country: Sweden
facility: Skanes universitetssjukhus
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Tiachung
country: Taiwan
facility: China Medical University Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Izmir
country: Turkey
facility: Ege University Medical of Faculty, Department of Gastroenterology
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Teknik University Medical Faculty
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: