Clinical Trials List
Protocol Number56136379HPB2001
2017-12-01 - 2020-08-05
Others
Terminated4
ICD-10B18.1
Chronic viral hepatitis B without delta-agent
ICD-10B18
Chronic viral hepatitis
ICD-9070.32
Viral hepatitis B without mention of hepatic coma, chronic, without mention of hepatitis delta
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
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Trial Applicant
Johnson & Johnson
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Sponsor
Johnson & Johnson
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 邱彥程 Division of General Internal Medicine
- Pin-Nan Cheng Division of General Internal Medicine
- 吳毅晉 Division of General Internal Medicine
- Chiu Hung Chiu Division of General Internal Medicine
- 簡世杰 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Co-Principal Investigator
- TENG-YU LEE Digestive System Department
- 葉宏仁 Digestive System Department
- 呂宜達 Digestive System Department
- 黃儀倢 Digestive System Department
- CHUNG-HSIN CHANG Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Linkou Chang Gung Medical Foundation
Taiwan National PI
葉昭廷
Co-Principal Investigator
- Yi-Cheng Chen Digestive System Department
- Chao-Wei Hsu Digestive System Department
- Chen-Chun Lin Digestive System Department
- Rong-Nan Chien Digestive System Department
- 朱允義 Digestive System Department
The Actual Total Number of Participants Enrolled
9 Completed
Audit
None
Co-Principal Investigator
- Chung-Feng Huang Digestive System Department
- Ming-Lun Yeh Digestive System Department
- Jee-Fu Huang Digestive System Department
- 黃駿逸 Digestive System Department
- Ming-Lung Yu Digestive System Department
- Chia-Yen Dai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Chronic Hepatitis B Virus Infection
Objectives
The purpose of this trial is to evaluate the efficacy of the 24-week trial treatment based on the degree of change in the concentration of hepatitis B surface antigen (HBsAg).
Test Drug
JNJ-56136379
Active Ingredient
JNJ-56136379
Dosage Form
tablet
Dosage
25 mg/tab 100 mg/tab
Endpoints
Analysis of main indicators
Change in HBsAg concentration since the base period at week 24
Secondary outcome indicators
1. Number of subjects with adverse events (AE)
2. Number of subjects with severe adverse events (SAE)
3. The number of subjects with abnormal vital signs, physical examination, electrocardiogram (ECG), and laboratory results with clinically significant significance
4. Changes in the concentration of hepatitis B surface antigen (HBsAg) compared to the baseline
5. The percentage of subjects whose hepatitis B surface antigen concentration is less than (<) 1,000 or less than 100 IU/mL
6. Compared with the base period, the percentage of subjects whose HBsAg decreased by more than (>) 0.5 or more than 1 log10 IU/mL
7. The change of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) concentration compared to the baseline
8. Percentage of subjects unable to detect HBV DNA concentration
9. The change of hepatitis B E antigen (HBeAg) concentration compared to the base period
10. Percentage of subjects with HBeAg concentration
11. Percentage of subjects with HBsAg or HBeAg serum clearance
12. Percentage of subjects with HBsAg or HBeAg seroconversion
13. The percentage of subjects whose standardized glutamate pyruvate transamination (ALT) concentration
14. Percentage of subjects experiencing viral breakthroughs
15. The concentration of NA (Entecavir [ETV] or Tenofovir Disoproxil Fumarate [TDF]) in plasma
16. Plasma concentration of JnJ-56136379
17. Percentage of subjects with treatment-related mutations
Other result indicators:
1. Subtest: The change in the concentration of hepatitis B covalently closed circular DNA in the liver at the 24th week and the 48th week compared to the baseline
2. Subtest: Changes in the transcriptional activity of hepatitis B covalently closed circular DNA at the 24th and 48th weeks compared to the base period
Change in HBsAg concentration since the base period at week 24
Secondary outcome indicators
1. Number of subjects with adverse events (AE)
2. Number of subjects with severe adverse events (SAE)
3. The number of subjects with abnormal vital signs, physical examination, electrocardiogram (ECG), and laboratory results with clinically significant significance
4. Changes in the concentration of hepatitis B surface antigen (HBsAg) compared to the baseline
5. The percentage of subjects whose hepatitis B surface antigen concentration is less than (<) 1,000 or less than 100 IU/mL
6. Compared with the base period, the percentage of subjects whose HBsAg decreased by more than (>) 0.5 or more than 1 log10 IU/mL
7. The change of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) concentration compared to the baseline
8. Percentage of subjects unable to detect HBV DNA concentration
9. The change of hepatitis B E antigen (HBeAg) concentration compared to the base period
10. Percentage of subjects with HBeAg concentration
11. Percentage of subjects with HBsAg or HBeAg serum clearance
12. Percentage of subjects with HBsAg or HBeAg seroconversion
13. The percentage of subjects whose standardized glutamate pyruvate transamination (ALT) concentration
14. Percentage of subjects experiencing viral breakthroughs
15. The concentration of NA (Entecavir [ETV] or Tenofovir Disoproxil Fumarate [TDF]) in plasma
16. Plasma concentration of JnJ-56136379
17. Percentage of subjects with treatment-related mutations
Other result indicators:
1. Subtest: The change in the concentration of hepatitis B covalently closed circular DNA in the liver at the 24th week and the 48th week compared to the baseline
2. Subtest: Changes in the transcriptional activity of hepatitis B covalently closed circular DNA at the 24th and 48th weeks compared to the base period
Inclution Criteria
Main inclusion criteria:
• Subjects must be 18 to 70 years of age, inclusive.
• Subjects must have CHB infection documented by:
Serum HBsAg-positive at screening and at least 6 months prior to screening;
Serum immunoglobulin M (IgM) anti-HBc antibody negative at screening.
In subjects currently not being treated (Treatment Arms 1-2-3 and 6-7-8):
Subjects must not be receiving any CHB treatment at screening, ie,
o Have never received treatment with HBV antiviral medicines, including NAs or
interferon (IFN) products, OR
o Have not been on treatment with HBV antiviral medicines, including NAs or IFN
products, within 6 months prior to baseline (first intake of study drugs), AND
Subjects must be HBeAg-positive and have HBV DNA 20,000 IU/mL, OR be
HBeAg-negative and have HBV DNA 2,000 IU /mL at screening, AND
Subjects must have HBsAg >250 IU/mL at screening, AND
Subjects must have ALT > upper limit of normal (ULN) and ≤5 x ULN at screening,
determined in the central laboratory.
Note: If subjects were treated with investigational anti-HBV agents more than 6 months
before screening, the sponsor should be contacted to discuss the case. Subjects who have
received treatment with a CAM for more than 4 weeks any time prior to screening are excluded.
• In virologically suppressed subjects (Treatment Arms 4-5 and 9-10):
Subjects must be virologically suppressed by current NA treatment (ETV or TDF) as
defined by HBV DNA <60 IU/mL at screening and at least 6 months prior to screening,
AND
Subjects must be on the same NA treatment (ETV or TDF) and the same dose for ≥12
months prior to screening, AND
Subjects must have HBsAg >250 IU/mL at screening, AND
Subjects must have ALT ≤2x ULN at screening.
Note: If subjects were treated with investigational anti-HBV agents more than 6 months
before screening, the sponsor should be contacted to discuss the case. Subjects who have
received treatment with a CAM for more than 4 weeks any time prior to screening are excluded.
• Subjects 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 kPa within 6 months prior to screening or at the time of screening.
• Subjects must be 18 to 70 years of age, inclusive.
• Subjects must have CHB infection documented by:
Serum HBsAg-positive at screening and at least 6 months prior to screening;
Serum immunoglobulin M (IgM) anti-HBc antibody negative at screening.
In subjects currently not being treated (Treatment Arms 1-2-3 and 6-7-8):
Subjects must not be receiving any CHB treatment at screening, ie,
o Have never received treatment with HBV antiviral medicines, including NAs or
interferon (IFN) products, OR
o Have not been on treatment with HBV antiviral medicines, including NAs or IFN
products, within 6 months prior to baseline (first intake of study drugs), AND
Subjects must be HBeAg-positive and have HBV DNA 20,000 IU/mL, OR be
HBeAg-negative and have HBV DNA 2,000 IU /mL at screening, AND
Subjects must have HBsAg >250 IU/mL at screening, AND
Subjects must have ALT > upper limit of normal (ULN) and ≤5 x ULN at screening,
determined in the central laboratory.
Note: If subjects were treated with investigational anti-HBV agents more than 6 months
before screening, the sponsor should be contacted to discuss the case. Subjects who have
received treatment with a CAM for more than 4 weeks any time prior to screening are excluded.
• In virologically suppressed subjects (Treatment Arms 4-5 and 9-10):
Subjects must be virologically suppressed by current NA treatment (ETV or TDF) as
defined by HBV DNA <60 IU/mL at screening and at least 6 months prior to screening,
AND
Subjects must be on the same NA treatment (ETV or TDF) and the same dose for ≥12
months prior to screening, AND
Subjects must have HBsAg >250 IU/mL at screening, AND
Subjects must have ALT ≤2x ULN at screening.
Note: If subjects were treated with investigational anti-HBV agents more than 6 months
before screening, the sponsor should be contacted to discuss the case. Subjects who have
received treatment with a CAM for more than 4 weeks any time prior to screening are excluded.
• Subjects 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 kPa within 6 months prior to screening or at the time of screening.
Exclusion Criteria
Main exclusion criteria:
• Subjects who test positive for anti-HBs antibodies.
• Subjects with current hepatitis A virus infection (confirmed by hepatitis A antibody 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 type 1 (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.
• Subjects with any evidence of hepatic decompensation at any time point prior to or at the time
of screening:
Direct bilirubin >1.2x ULN, or
International normalized ratio >1.5x ULN, or
Serum albumin < lower limit of normal (LLN), or
Documented history or current evidence of variceal bleeding, ascites, or hepatic encephalopathy.
• Subjects with any evidence of liver disease of non-HBV etiology. This includes but is not
limited to hepatitis virus infections mentioned above, drug- or alcohol-related liver disease,
autoimmune hepatitis, hemochromatosis, Wilson’s disease, Gilbert’s syndrome, α-1 antitrypsin
deficiency, primary biliary cirrhosis, primary sclerosing cholangitis, or any other non-HBV
liver disease considered clinically significant by the investigator.
• Subjects who have signs of hepatocellular carcinoma (HCC) on an abdominal ultrasound
performed within 2 months prior to screening or at the time of screening. In case of suspicious
findings on conventional ultrasound the subject may still be eligible if HCC has been ruled out
by a more specific imaging procedure (contrast enhanced ultrasound, computed tomography
[CT] or magnetic resonance imaging [MRI]).
• Subjects who test positive for anti-HBs antibodies.
• Subjects with current hepatitis A virus infection (confirmed by hepatitis A antibody 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 type 1 (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.
• Subjects with any evidence of hepatic decompensation at any time point prior to or at the time
of screening:
Direct bilirubin >1.2x ULN, or
International normalized ratio >1.5x ULN, or
Serum albumin < lower limit of normal (LLN), or
Documented history or current evidence of variceal bleeding, ascites, or hepatic encephalopathy.
• Subjects with any evidence of liver disease of non-HBV etiology. This includes but is not
limited to hepatitis virus infections mentioned above, drug- or alcohol-related liver disease,
autoimmune hepatitis, hemochromatosis, Wilson’s disease, Gilbert’s syndrome, α-1 antitrypsin
deficiency, primary biliary cirrhosis, primary sclerosing cholangitis, or any other non-HBV
liver disease considered clinically significant by the investigator.
• Subjects who have signs of hepatocellular carcinoma (HCC) on an abdominal ultrasound
performed within 2 months prior to screening or at the time of screening. In case of suspicious
findings on conventional ultrasound the subject may still be eligible if HCC has been ruled out
by a more specific imaging procedure (contrast enhanced ultrasound, computed tomography
[CT] or magnetic resonance imaging [MRI]).
The Estimated Number of Participants
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Taiwan
32 participants
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Global
232 participants
