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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05123599




Registration number
NCT05123599
Ethics application status
Date submitted
16/11/2021
Date registered
17/11/2021

Titles & IDs
Public title
A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
Scientific title
A Phase 1b, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Treatment With JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, HBeAg-negative Participants With Chronic Hepatitis B Virus Infection
Secondary ID [1] 0 0
2020-005584-30
Secondary ID [2] 0 0
CR109042
Universal Trial Number (UTN)
Trial acronym
OSPREY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-73763989
Treatment: Other - JNJ-64300535
Treatment: Drugs - ETV monohydrate
Treatment: Drugs - Tenofovir disoproxil
Treatment: Drugs - TAF

Experimental: JNJ-73763989 plus JNJ-64300535 plus Nucleos(t)ide Analogs (NAs) - Participants will receive JNJ-73763989 subcutaneous (SC) injection once every 4 weeks (q4w), NA (either Entecavir monohydrate \[ETV\], Tenofovir disoproxil or Tenofovir alafemide \[TAF\]) oral tablets once daily (qd) and JNJ-64300535 intramuscular (IM) injection q4w. From day 187, participants will receive treatment with NA oral tablets qd up to Week 36.


Treatment: Drugs: JNJ-73763989
JNJ-73763989 injection will be administered subcutaneously.

Treatment: Other: JNJ-64300535
JNJ-64300535 deoxyribonucleic acid (DNA) vaccine injection will be administered intramuscularly.

Treatment: Drugs: ETV monohydrate
ETV monohydrate film-coated tablets will be administered orally.

Treatment: Drugs: Tenofovir disoproxil
Tenofovir disoproxil film-coated tablets will be administered orally.

Treatment: Drugs: TAF
TAF film-coated tablets will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with a Reduction of at Least 2 log10 International Units per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline to Week 36
Timepoint [1] 0 0
Baseline to Week 36 (end of study intervention)
Secondary outcome [1] 0 0
Percentage of Participants with at Least 3-fold Increase in Hepatitis B Virus (HBV)- Specific T-Cell Response Against Vaccine Antigen HBV Core and/or Pol
Timepoint [1] 0 0
From Day 103 up to Week 84
Secondary outcome [2] 0 0
Percentage of Responders Against Vaccine Antigen HBV Core and/or Pol
Timepoint [2] 0 0
Week 28
Secondary outcome [3] 0 0
Percentage of Participants with Adverse Events (AEs)
Timepoint [3] 0 0
Up to Week 84
Secondary outcome [4] 0 0
Percentage of Participants with Serious AEs
Timepoint [4] 0 0
Up to Week 84
Secondary outcome [5] 0 0
Percentage of Participants with Abnormalities in Clinical Laboratory Tests
Timepoint [5] 0 0
Up to Week 84
Secondary outcome [6] 0 0
Percentage of Participants with Abnormalities in 12- lead Electrocardiograms (ECGs)
Timepoint [6] 0 0
Up to Week 84
Secondary outcome [7] 0 0
Percentage of Participants with Abnormalities in Vital Signs
Timepoint [7] 0 0
Up to Week 84
Secondary outcome [8] 0 0
Percentage of Participants with Abnormalities in Physical Examinations
Timepoint [8] 0 0
Up to Week 84
Secondary outcome [9] 0 0
Percentage of Participants with Solicited Local AEs for JNJ-64300535 up to 7 Days Post Each Vaccination
Timepoint [9] 0 0
7 days post each vaccination (Up to Day 194)
Secondary outcome [10] 0 0
Percentage of Participants with Solicited Systematic AEs for JNJ-64300535 up to 7 Days Post Each Vaccination
Timepoint [10] 0 0
7 days post each vaccination (Up to Day 194)
Secondary outcome [11] 0 0
Change from Baseline Over Time in HBsAg Levels
Timepoint [11] 0 0
Baseline up to Week 84
Secondary outcome [12] 0 0
Change from Start of Vaccination Over Time in HBsAg Levels
Timepoint [12] 0 0
From Day 103 up to Week 84
Secondary outcome [13] 0 0
Percentage of Participants with HBsAg, HBV Deoxyribonucleic Acid (DNA) and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs
Timepoint [13] 0 0
Up to Week 84
Secondary outcome [14] 0 0
Percentage of Participants with HBsAg Seroclearance
Timepoint [14] 0 0
Up to Week 84
Secondary outcome [15] 0 0
Percentage of Participants with HBsAg Seroconversion
Timepoint [15] 0 0
Up to Week 84
Secondary outcome [16] 0 0
Time to Achieve HBsAg Seroclearance
Timepoint [16] 0 0
Up to Week 84
Secondary outcome [17] 0 0
Time to Achieve HBsAg Seroconversion
Timepoint [17] 0 0
Up to Week 84
Secondary outcome [18] 0 0
Percentage of Participants Meeting Nucleos(t)ide Analog (NA) Treatment Completion Criteria
Timepoint [18] 0 0
Week 38 and Week 40
Secondary outcome [19] 0 0
Percentage of Participants with Virological Breakthrough
Timepoint [19] 0 0
Up to Week 36
Secondary outcome [20] 0 0
Percentage of Participants with HBsAg Seroclearance at Week 60 and Week 84
Timepoint [20] 0 0
Weeks 60 and 84
Secondary outcome [21] 0 0
Percentage of Participants with HBV DNA <LLOQ at Week 60 and Week 84
Timepoint [21] 0 0
Weeks 60 and 84
Secondary outcome [22] 0 0
Percentage of Participants with Viral Flares
Timepoint [22] 0 0
From Week 36 to Week 84
Secondary outcome [23] 0 0
Percentage of Participants with Biochemical Flares
Timepoint [23] 0 0
From Week 36 to Week 84
Secondary outcome [24] 0 0
Number of TriGrid Delivery System (TDS)-Intramuscular (IM) version 2.0 Device Fault Conditions by Type
Timepoint [24] 0 0
From Day 103 to Day 187

Eligibility
Key inclusion criteria
* Participants must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* Participants must have a body mass index (BMI; weight in kilograms [kg] divided by the square of height in meters) between 19.0 and 32.0 kilograms per meter square (kg/m^2), extremes included
* A woman of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day 1 before the first dose of study intervention
* Participants must have chronic hepatitis B virus (HBV) infection. HBV infection must be documented by serum hepatitis B surface antigen (HBsAg) positivity at screening. In addition, chronicity must be documented by any of the following, at least 6 months prior to screening: serum HBsAg positivity, hepatitis B e antigen (HBeAg) positivity or HBV deoxyribonucleic acid (DNA) positivity, alanine aminotransferase (ALT) elevation above upper limit of normal (ULN) without another cause than HBV infection, documented transmission event. If none of the above are available, the following ways of documenting chronicity are acceptable at the time of screening: liver biopsy with changes consistent with chronic HBV, or absence of marker for acute HBV infection such as positive immunoglobulin M (IgM) anti- hepatitis B surface protein (HBs) and anti- hepatitis B core protein (HBc) antibodies. Virologically suppressed participants should: a) be HBeAg-negative and anti- hepatitis B e (HBe) positive, b) be on stable HBV treatment, defined as currently receiving nucleos(t)ide analog (NA) treatment for at least 6 months prior to screening and having been on the same NA treatment regimen (at the same dose) as used in this study for at least 3 months at the time of screening, c) have serum HBV deoxyribonucleic acid (DNA) less than (<) 60 International units per milliliter (IU/mL) on 2 sequential measurements at least 6 months apart (one of which is at screening), and d) have documented ALT values <2.0* ULN on 2 sequential measurements at least 6 months apart (one of which is at screening)
* Participants must have: a) Fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kPa within 6 months prior to screening or at the time of screening, or b) If a Fibroscan result is not available: a liver biopsy result classified as Metavir F0-F2 within 1 year prior to screening
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
* Participants with a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which are considered cured with minimal risk of recurrence)
* Participants with any history of or current clinically significant skin disease requiring regular or periodic treatment
* Participants with clinically relevant alcohol or drug abuse within 12 months of screening
* Participants who had major surgery (example, requiring general anesthesia), excluding diagnostic surgery, within 12 weeks before screening; or will not have fully recovered from surgery; or have surgery planned during the time of expected participation in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/06/2024
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Edegem
Country [2] 0 0
France
State/province [2] 0 0
Clichy
Country [3] 0 0
France
State/province [3] 0 0
Lyon
Country [4] 0 0
Italy
State/province [4] 0 0
Milano
Country [5] 0 0
Italy
State/province [5] 0 0
Pisa
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
Poland
State/province [7] 0 0
Myslowice
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Spain
State/province [9] 0 0
Santander
Country [10] 0 0
Taiwan
State/province [10] 0 0
Kaohsiung City
Country [11] 0 0
Taiwan
State/province [11] 0 0
Tao Yuan
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05123599