We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 311 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection

This study is not yet open for participant recruitment.
Verified December 2017 by Janssen Sciences Ireland UC
Sponsor:
ClinicalTrials.gov Identifier:
NCT03361956
First Posted: December 5, 2017
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Sciences Ireland UC
  Purpose
The purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.

Condition Intervention Phase
Hepatitis B Drug: JNJ-56136379 Drug: Placebo Drug: NA (ETV or TDF) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of 24 Weeks 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

Resource links provided by NLM:


Further study details as provided by Janssen Sciences Ireland UC:

Primary Outcome Measures:
  • Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels at Week 24 [ Time Frame: Baseline and Week 24 ]
    Change from baseline in Hepatitis B surface antigen (HBsAg) levels at week 24 will be assessed.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Up to Follow Up (Week 48) ]
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to Follow Up (Week 48) ]
    A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  • Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), Clinically Significant Laboratory Findings [ Time Frame: Up to Follow Up (Week 48) ]
    Number of participants with abnormalities in vital signs, physical examinations, ECG, clinically significant laboratory findings will be assessed.

  • Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels [ Time Frame: Baseline up to follow up (Week 48) ]
    Change from baseline in Hepatitis B surface antigen (HBsAg) levels will be assessed.

  • Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 IU/mL [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 26, 28, 36 and 48 ]
    Percentage of participants with HBsAg levels less than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) will be assessed.

  • Percentage of Participants With Greater Than (>) 0.5 or >1 log10 IU/mL Reduction in HBsAg From Baseline [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 26, 28, 36 and 48 ]
    Percentage of participants with >0.5 or >1 log10 IU/mL reduction in HBsAg from baseline will be assessed.

  • Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) Levels [ Time Frame: Baseline up to follow up (Week 48) ]
    Change from baseline in Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels will be assessed.

  • Percentage of Participants With Undetectable HBV DNA Levels [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 26, 28, 36 and 48 ]
    Percentage of participants with undetectable HBV DNA levels will be evaluated.

  • Change From Baseline in Hepatitis B E Antigen (HBeAg) Levels [ Time Frame: Baseline up to follow up (Week 48) ]
    Change from baseline in Hepatitis B E antigen (HBeAg) levels will be assessed.

  • Percentage of Participants by HBeAg Levels [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 26, 28, 36 and 48 ]
    Percentage of participants by HBeAg levels will be evaluated.

  • Percentage of Participants With HBsAg or HBeAg Seroclearance [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 26, 28, 36 and 48 ]
    Percentage of participants with seroclearance (defined as HBsAg or HBeAg negativity, respectively) will be assessed.

  • Percentage of Participants With HBsAg or HBeAg Seroconversion [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 26, 28, 36 and 48 ]
    Percentage of participants with seroconversion (defined as HBsAg or HBeAg negativity and anti-HBs or anti-HBe antibody positivity, respectively) will be assessed.

  • Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 26, 28, 36 and 48 ]
    Percentage of participants with normalized alanine aminotransferase (ALT) levels will be assessed whose ALT levers above upper limit of normal at baseline.

  • Percentage of Participants With Virological Breakthrough [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 ]
    Percentage of participants with viral breakthrough defined as confirmed on treatment HBV DNA increase by greater than (>) 1 log10 from nadir level or confirmed on treatment level >200 International Units Per Milliliter (IU/mL) in participants who had HBV DNA level below the lower limit of quantification (LLOQ) of the HBV DNA assay.

  • Plasma Concentrations of NA (Entecavir [ETV] or Tenofovir Disoproxil Fumarate [TDF]) [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 20, 24, 26 and 28 ]
    Plasma concentrations of NA (entecavir [ETV] or tenofovir disoproxil fumarate [TDF]) administered as monotherapy or co-administered with JNJ-56136379, will be determined.

  • Plasma Concentrations of JnJ-56136379 [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 20, 24, 26 and 28 ]
    Plasma concentrations of JNJ-56136379 administered as monotherapy or when co-administered with NA (ETV or TDF), will be determined.

  • Percentage of Participants With Treatment-Associated Mutations [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 36 and 48 ]
    Viral genome sequence analysis will be performed to evaluate emergence of mutations associated with JNJ-56136379 and/or ETV or TDF treatment.


Estimated Enrollment: 220
Anticipated Study Start Date: February 5, 2018
Estimated Study Completion Date: June 20, 2020
Estimated Primary Completion Date: October 18, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: Arm 1 (JNJ-56136379) (open label)
Participants with hepatitis B virus (HBV) currently not being treated will receive JNJ-56136379 tablet orally for 24 weeks.
Drug: JNJ-56136379
Participants will receive JNJ-56136379 tablet orally.
Other Name: JNJ-379
Placebo Comparator: Part A: Arm 2 (Placebo+NA [ETV] or [TDF])
Participants with HBV currently not being treated will receive matching placebo along with nucleos(t)ide analog (NA) (entecavir [ETV] or tenofovir disoproxil fumarate [TDF]) tablets orally for 24 weeks.
Drug: Placebo
Participants will receive matching placebo tablet orally.
Drug: NA (ETV or TDF)
Participants will receive NA (ETV or TDF) tablet orally as per approved label.
Experimental: Part A: Arm 3 (JNJ-56136379 + NA [ETV or TDF])
Participants with HBV currently not being treated will receive JNJ-56136379 along with NA (ETV or TDF) tablet orally for 24 weeks.
Drug: JNJ-56136379
Participants will receive JNJ-56136379 tablet orally.
Other Name: JNJ-379
Drug: NA (ETV or TDF)
Participants will receive NA (ETV or TDF) tablet orally as per approved label.
Placebo Comparator: Part A: Arm 4 (Placebo + NA [ETV or TDF])
Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks.
Drug: Placebo
Participants will receive matching placebo tablet orally.
Drug: NA (ETV or TDF)
Participants will receive NA (ETV or TDF) tablet orally as per approved label.
Experimental: Part A: Arm 5 (JNJ-56136379 + NA [ETV or TDF])
Virologically suppressed participants will receive JNJ-56136379 along with NA (ETV or TDF) tablets orally for 24 weeks.
Drug: JNJ-56136379
Participants will receive JNJ-56136379 tablet orally.
Other Name: JNJ-379
Drug: NA (ETV or TDF)
Participants will receive NA (ETV or TDF) tablet orally as per approved label.
Experimental: Part B: Arm 6 (JNJ-56136379) (open label)
Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose (to be decided) orally for 24 weeks.
Drug: JNJ-56136379
Participants will receive JNJ-56136379 tablet orally.
Other Name: JNJ-379
Placebo Comparator: Part B: Arm 7 (placebo + NA [ETV or TDF])
Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks.
Drug: Placebo
Participants will receive matching placebo tablet orally.
Drug: NA (ETV or TDF)
Participants will receive NA (ETV or TDF) tablet orally as per approved label.
Experimental: Part B: Arm 8 (JNJ-56136379 + NA [ETV or TDF])
Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose (to be decided) along with NA (ETV or TDF) tablets orally for 24 weeks.
Drug: JNJ-56136379
Participants will receive JNJ-56136379 tablet orally.
Other Name: JNJ-379
Drug: NA (ETV or TDF)
Participants will receive NA (ETV or TDF) tablet orally as per approved label.
Placebo Comparator: Part B: Arm 9 (placebo + NA [ETV or TDF])
Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks.
Drug: Placebo
Participants will receive matching placebo tablet orally.
Drug: NA (ETV or TDF)
Participants will receive NA (ETV or TDF) tablet orally as per approved label.
Experimental: Part B: Arm 10 (JNJ-56136379 + NA [ETV or TDF])
Virologically suppressed participants will receive JNJ-56136379 tablet at a high dose (to be decided) along with NA (ETV or TDF) tablets orally for 24 weeks.
Drug: JNJ-56136379
Participants will receive JNJ-56136379 tablet orally.
Other Name: JNJ-379
Drug: NA (ETV or TDF)
Participants will receive NA (ETV or TDF) tablet orally as per approved label.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have a body mass index (weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 35.0 kilogram / square meter (kg/m^2), extremes included
  • Participants must have chronic hepatitis B virus infection (CHB) infection documented by: Serum hepatitis B surface antigen (HBsAg)-positive at screening and at least 6 months prior to screening; Serum immunoglobulin M (IgM) anti- hepatitis B core-related (HBc) antibody negative at screening
  • In participants currently not being treated (Treatment Arms 1-2-3 and 6-7-8): Participants must not be receiving any CHB treatment at screening, that is, Have never received treatment with HBV antiviral medicines, including NAs or interferon (IFN) products, OR Have not been on treatment with HBV antiviral medicines, including nucleos(t)ide analog (NA)s or IFN products within 6 months prior to baseline (first intake of study drugs), and participants must be HBeAg-positive and have hepatitis B virus (HBV) deoxyribonucleic acid (DNA) greater than or equal to (>=) 20,000 International Units Per Milliliter (IU/mL), OR be hepatitis B e antigen (HBeAg)-negative and have HBV DNA >=2,000 IU /mL at screening, and participants must have HBsAg greater than (>) 250 IU/mL at screening, and participants must have alanine aminotransferase (ALT) > upper limit of normal (ULN) and less than or equal to (<=) 5 * ULN at screening, determined in the central laboratory
  • In virologically suppressed participants (Treatment Arms 4-5 and 9-10): Participants must be virologically suppressed by current NA treatment (entecavir (ETV) or tenofovir disoproxil fumarate (TDF)) as defined by HBV DNA less than (<) 60 IU/mL at screening and at least 6 months prior to screening, and participants must be on the same NA treatment (ETV or TDF) and the same dose for >=12 months prior to screening, and participants must have HBsAg > 250 IU/mL at screening, and participants must have ALT <=2*ULN at screening
  • Participants must have: A liver biopsy result classified as Metavir F0-F2 within 1 year prior to screening or at the time of screening, OR FibroScan liver stiffness measurement <8.0 kilopascal (kPa) within 6 months prior to screening or at the time of screening

Exclusion Criteria:

  • Participants who test positive for anti-hepatitis B surface (HBs) antibodies
  • Participants with current hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), hepatitis C virus (HCV) infection (confirmed by HCV antibody), hepatitis D virus (HDV) infection (confirmed by HDV antibody), hepatitis E virus infection (confirmed by hepatitis E antibody IgM), or human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening. Evidence of other active infection (bacterial, viral, fungal, including acute tuberculosis) deemed clinically relevant by the investigator that would interfere with study conduct or its interpretation will also lead to exclusion
  • Participants with any evidence of hepatic decompensation at any time point prior to or at the time of screening: Direct bilirubin >1.2* ULN, or International normalized ratio (INR) >1.5* ULN, or Serum albumin < lower limit of normal (LLN), or documented history or current evidence of variceal bleeding, ascites, or hepatic encephalopathy
  • Participants with a history of cardiac arrhythmia (example, extrasystoli, tachycardia at rest), history of risk factors for Torsades de Pointes syndrome (example, hypokalemia, family history of long QT syndrome) or history or other clinical evidence of significant or unstable cardiac disease (example, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant 12 lead electrocardiograms (ECGs) abnormalities), moderate to severe valvular disease, or uncontrolled hypertension at screening
  • Participants with contraindications to the use of ETV or TDF per local prescribing information
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361956


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

  Show 42 Study Locations
Sponsors and Collaborators
Janssen Sciences Ireland UC
Investigators
Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC
  More Information

Responsible Party: Janssen Sciences Ireland UC
ClinicalTrials.gov Identifier: NCT03361956     History of Changes
Other Study ID Numbers: CR108410
2017-001110-29 ( EudraCT Number )
56136379HPB2001 ( Other Identifier: Janssen Sciences Ireland UC )
First Submitted: November 29, 2017
First Posted: December 5, 2017
Last Update Posted: December 11, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Virus Diseases
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections