Clinical Trials List
Protocol NumberSBP-9200-HBV-201
NCT Number(ClinicalTrials.gov Identfier)NCT02751996
2016-08-01 - 2019-04-15
Phase II
Terminated5
ICD-10B18.1
Chronic viral hepatitis B without delta-agent
ICD-9070.32
Viral hepatitis B without mention of hepatic coma, chronic, without mention of hepatitis delta
A Phase 2, Open-Label, Randomized Two-part, Multiple Dose Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected with Chronic Hepatitis B Virus
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Spring Bank Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- I-Shyan Sheen Digestive System Department
- 滕威 Digestive System Department
- Chun-Yen Lin Digestive System Department
- Chien-Hao Huang Digestive System Department
- 陳威廷 Digestive System Department
- Yi-Chung Hsieh Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 林政寬 Digestive System Department
- Sheng-Wei Cheng Digestive System Department
- Chih-Shiang Chang Digestive System Department
- 翁孟慈 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- PEI-JER CHEN Digestive System Department
- 蘇東弘 Digestive System Department
- Chen-Hua Liu Digestive System Department
- 楊宏志 Digestive System Department
- Jia-Horng Kao Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
HBV
Objectives
Primary Objectives:
The primary objective for Part A of the study is to evaluate the
safety and antiviral effect of SB 9200 in subjects infected with
chronic hepatitis B virus (HBV) at 12 weeks in comparison with
placebo.
The primary objective for Part B of the study is to evaluate the
antiviral effect and safety of SB 9200 in combination with
tenofovir in subjects infected with chronic HBV at 12 weeks in
comparison with tenofovir monotherapy.
Secondary Objectives:
• To further assess exposure to SB 9200 and metabolites
(Sp-SB 9000 and Rp-SB 9000) in subjects who are
infected with chronic HBV
• To select doses of SB 9200 that exhibit significant
antiviral response and safety for the treatment of chronic
HBV infection (Part A)
• To assess the antiviral effect of continuing tenofovir from
Weeks 12 to 24
• To assess the effect of SB 9200 alone and in combination
with tenofovir on HBV ribonucleic acid (RNA)
Test Drug
SB 9200
Active Ingredient
SB 9200
Dosage Form
Capsule
Dosage
25mg/100mg
Endpoints
The primary endpoint for safety and efficacy in Part A is the
proportion of subjects reporting an adverse event (AE) or
experiencing a clinically significant AE or laboratory abnormality
from Baseline to end of SB 9200 treatment (12 weeks) and the
change from Baseline to Week 12 in log10 HBV deoxyribonucleic
acid (DNA), respectively, to enable dose selection for Part B.
All virology primary and secondary efficacy endpoint data for
Part A will be derived from the data supplied by the designated
Core Virology Laboratory.
The primary endpoints for safety and efficacy in Part B is the
proportion of subjects reporting an AE or experiencing a clinically
significant AE or laboratory abnormality from Baseline to the end
of SB 9200 treatment (12 weeks) and the proportion of subjects
with hepatitis B surface antigen (HBsAg) ≥ 0.5 log10 reduction
from Baseline to Week 12, respectively.
All virology primary and secondary efficacy endpoint data for
Part B will be derived from the data supplied by the designated
Core Virology Laboratory.
The secondary endpoints for both parts of the study are listed
below:
• Measurement of SB 9200 and Rp- and Sp-SB 9000
plasma concentrations and determination of PK
parameters for SB 9200, Rp-SB 9000, and Sp-SB 9000
(Parts A and B)
• Change in serum HBV DNA, HBsAg, and HBV RNA in
log10 IU/mL from Baseline to Weeks 2, 4, 8, 12, 14, and
24 (Part A)
• Change in serum HBV DNA, HBsAg, and HBV RNA in
log10 IU/mL from Baseline to Weeks 2, 4, 6, 12, 14, and
24 (Part B)
• Change in hepatitis B envelope antigen (HBeAg) in log10
IU/mL from Baseline to Weeks 2, 4, 8, 12, 14, and 24
(Part A)
• Change in HBeAg in log10 IU/mL from Baseline to
Weeks 2, 4, 6, 12, 14, and 24 (Part B)
• Proportion of subjects with HBeAg or HBsAg loss and
seroconversion at Weeks 2, 4, 8, 12, 14, and 24 (Part A)
• Proportion of subjects with HBeAg or HBsAg loss and
seroconversion at Weeks 2, 4, 6, 12, 14, and 24 (Part B)
• Proportion of subjects with HBsAg ≥ 1 log10 reduction
from Baseline to Week 12 (Part B)
proportion of subjects reporting an adverse event (AE) or
experiencing a clinically significant AE or laboratory abnormality
from Baseline to end of SB 9200 treatment (12 weeks) and the
change from Baseline to Week 12 in log10 HBV deoxyribonucleic
acid (DNA), respectively, to enable dose selection for Part B.
All virology primary and secondary efficacy endpoint data for
Part A will be derived from the data supplied by the designated
Core Virology Laboratory.
The primary endpoints for safety and efficacy in Part B is the
proportion of subjects reporting an AE or experiencing a clinically
significant AE or laboratory abnormality from Baseline to the end
of SB 9200 treatment (12 weeks) and the proportion of subjects
with hepatitis B surface antigen (HBsAg) ≥ 0.5 log10 reduction
from Baseline to Week 12, respectively.
All virology primary and secondary efficacy endpoint data for
Part B will be derived from the data supplied by the designated
Core Virology Laboratory.
The secondary endpoints for both parts of the study are listed
below:
• Measurement of SB 9200 and Rp- and Sp-SB 9000
plasma concentrations and determination of PK
parameters for SB 9200, Rp-SB 9000, and Sp-SB 9000
(Parts A and B)
• Change in serum HBV DNA, HBsAg, and HBV RNA in
log10 IU/mL from Baseline to Weeks 2, 4, 8, 12, 14, and
24 (Part A)
• Change in serum HBV DNA, HBsAg, and HBV RNA in
log10 IU/mL from Baseline to Weeks 2, 4, 6, 12, 14, and
24 (Part B)
• Change in hepatitis B envelope antigen (HBeAg) in log10
IU/mL from Baseline to Weeks 2, 4, 8, 12, 14, and 24
(Part A)
• Change in HBeAg in log10 IU/mL from Baseline to
Weeks 2, 4, 6, 12, 14, and 24 (Part B)
• Proportion of subjects with HBeAg or HBsAg loss and
seroconversion at Weeks 2, 4, 8, 12, 14, and 24 (Part A)
• Proportion of subjects with HBeAg or HBsAg loss and
seroconversion at Weeks 2, 4, 6, 12, 14, and 24 (Part B)
• Proportion of subjects with HBsAg ≥ 1 log10 reduction
from Baseline to Week 12 (Part B)
Inclution Criteria
1. Documented evidence of chronic HBV infection (eg, HBsAg-positive for at least 6 months or HBV DNA positive for at least 6 months). In the absence of documented evidence of HBsAg or HBV DNA, the subject must be HBsAg-positive and anti-HBc IgM negative at Screening.
2. Not on any antiviral medications for at least 6 months. If a subject is HBeAg negative, they will be eligible if they have not received antiviral medications for at least 3 months. Antiviral medications include lamivudine, telbivudine, adefovir, tenofovir, entecavir, IFN therapies of any type, and all other medications with potential antiviral activity.
3. HBV DNA > 2000 IU/mL for HBeAg-negative subjects and > 20000 IU/mL for HBeAg-positive subjects at Screening
4. Alanine aminotransferase (ALT) > upper limit of normal (ULN), but < 5 × the ULN and ≤ 200 U/L
5. Ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 3 months of randomization date with no evidence of hepatocellular carcinoma
6. Must be willing and able to comply with all study requirements
7. Negative urine or serum pregnancy test (for women of childbearing potential [WOCBP]) documented within the 24-hour period prior to the first dose of test drug. If the urine pregnancy test is positive, a follow-up serum test is required for confirmation. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion. All fertile males must also refrain from sperm donation while on IP and for 3 months after completion of IP.
8. Must have the ability to understand and sign a written informed consent form (ICF); consent must be obtained prior to initiation of study procedures
Inclusion Criteria for Extension Period
Subjects who meet all of the following inclusion criteria may be eligible to be enrolled into the Extension Period:
1. Signed informed consent form
2. Subject was randomized in Part A or Part B.
2. Not on any antiviral medications for at least 6 months. If a subject is HBeAg negative, they will be eligible if they have not received antiviral medications for at least 3 months. Antiviral medications include lamivudine, telbivudine, adefovir, tenofovir, entecavir, IFN therapies of any type, and all other medications with potential antiviral activity.
3. HBV DNA > 2000 IU/mL for HBeAg-negative subjects and > 20000 IU/mL for HBeAg-positive subjects at Screening
4. Alanine aminotransferase (ALT) > upper limit of normal (ULN), but < 5 × the ULN and ≤ 200 U/L
5. Ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 3 months of randomization date with no evidence of hepatocellular carcinoma
6. Must be willing and able to comply with all study requirements
7. Negative urine or serum pregnancy test (for women of childbearing potential [WOCBP]) documented within the 24-hour period prior to the first dose of test drug. If the urine pregnancy test is positive, a follow-up serum test is required for confirmation. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion. All fertile males must also refrain from sperm donation while on IP and for 3 months after completion of IP.
8. Must have the ability to understand and sign a written informed consent form (ICF); consent must be obtained prior to initiation of study procedures
Inclusion Criteria for Extension Period
Subjects who meet all of the following inclusion criteria may be eligible to be enrolled into the Extension Period:
1. Signed informed consent form
2. Subject was randomized in Part A or Part B.
Exclusion Criteria
1. Any prior liver biopsy evidence of metavir F3 or F4 disease
2. Any history of decompensation of liver disease including history of ascites, encephalopathy, or varices
3. Evidence of cirrhosis as defined by Fibroscan at the Screening Visit of ≥ 8 kilopascals (kPa) or both a Fibrotest ≥ 0.65 and AST:platelet ratio index (APRI) ≥ 1.0 (subjects will not be excluded if only 1 of the Fibrotest or APRI result is higher than allowed) or have had evidence of Metavir F3-F4 on liver biopsy at any time
4. Laboratory parameters not within defined thresholds: white blood cells < 4000 cells/µL (SI unit < 4.0 × 109/L), hemoglobin (HgB) < 12 g/dL (SI unit < 120 g/L) for females, < 13 g/dL (SI unit < 130 g/L) for males, platelets < 130,000 per µL (SI unit < 130 × 109/L), albumin < 3.5 g/dL (SI unit < 35 g/L), international normalized ratio (INR) > 1.5, total bilirubin > 1.2 mg/dL (SI unit > 20.52 µmol/L), or alpha-fetoprotein (AFP) > 50 ng/mL (SI unit > 180.25 nmol/L). Subjects with an elevated indirect bilirubin and known Gilbert’s disease can be included if direct bilirubin is within normal limits. Subjects with an AFP > 50 ng/mL but ˂ 500 ng/mL can be included if computed tomography (CT) scan or magnetic resonance imaging (MRI) performed within 3 months shows no evidence of hepatocellular carcinoma.
5. Creatinine > 1.2 mg/dL (SI unit > 106.08 µmol/L), creatinine clearance < 50 mL/min (SI unit < 0.83 L/s/m2)
6. Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus
7. Evidence or history of hepatocellular carcinoma
8. Malignancy within 5 years prior to Screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible.
9. Significant cardiovascular, pulmonary, or neurological disease
10. Received solid organ or bone marrow transplant
11. Received within 3 months of Screening or expected to receive prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, IFN)
12. Subjects currently taking medication(s) that are transported through organic anion transporting polypeptide 1 (OATP1) including, but not limited to, atazanavir, rifampin, cyclosporine, eltrombopag, gemfibrozil, lopinavir/ritonavir, and saquinavir
13. Use of another investigational agent within 3 months of Screening
14. Current alcohol or substance abuse judged by the Investigator to potentially interfere with compliance
15. Females who are pregnant or may wish to become pregnant during the study
16. If the Investigator believes the prospective subject will not be able to comply with the requirements of the protocol and complete the study
17. Any medical condition, in the opinion of the Investigator, that could interfere with evaluation of the study objectives or safety of the subjects
Exclusion Criteria for Extension Period Subjects who meet any of the following exclusion criteria are not to be enrolled into the Extension Period:
1. Any condition, comorbidity, or laboratory abnormality that, based on the package insert of tenofovir or in the opinion of the Investigator, excludes the subject
2. Subjects who were withdrawn from Part A or Part B due to an AE or serious adverse event (SAE) related to the use of tenofovir
3. Participation in any other interventional study
4. Subject fully terminated from Part A or Part B
2. Any history of decompensation of liver disease including history of ascites, encephalopathy, or varices
3. Evidence of cirrhosis as defined by Fibroscan at the Screening Visit of ≥ 8 kilopascals (kPa) or both a Fibrotest ≥ 0.65 and AST:platelet ratio index (APRI) ≥ 1.0 (subjects will not be excluded if only 1 of the Fibrotest or APRI result is higher than allowed) or have had evidence of Metavir F3-F4 on liver biopsy at any time
4. Laboratory parameters not within defined thresholds: white blood cells < 4000 cells/µL (SI unit < 4.0 × 109/L), hemoglobin (HgB) < 12 g/dL (SI unit < 120 g/L) for females, < 13 g/dL (SI unit < 130 g/L) for males, platelets < 130,000 per µL (SI unit < 130 × 109/L), albumin < 3.5 g/dL (SI unit < 35 g/L), international normalized ratio (INR) > 1.5, total bilirubin > 1.2 mg/dL (SI unit > 20.52 µmol/L), or alpha-fetoprotein (AFP) > 50 ng/mL (SI unit > 180.25 nmol/L). Subjects with an elevated indirect bilirubin and known Gilbert’s disease can be included if direct bilirubin is within normal limits. Subjects with an AFP > 50 ng/mL but ˂ 500 ng/mL can be included if computed tomography (CT) scan or magnetic resonance imaging (MRI) performed within 3 months shows no evidence of hepatocellular carcinoma.
5. Creatinine > 1.2 mg/dL (SI unit > 106.08 µmol/L), creatinine clearance < 50 mL/min (SI unit < 0.83 L/s/m2)
6. Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus
7. Evidence or history of hepatocellular carcinoma
8. Malignancy within 5 years prior to Screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible.
9. Significant cardiovascular, pulmonary, or neurological disease
10. Received solid organ or bone marrow transplant
11. Received within 3 months of Screening or expected to receive prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, IFN)
12. Subjects currently taking medication(s) that are transported through organic anion transporting polypeptide 1 (OATP1) including, but not limited to, atazanavir, rifampin, cyclosporine, eltrombopag, gemfibrozil, lopinavir/ritonavir, and saquinavir
13. Use of another investigational agent within 3 months of Screening
14. Current alcohol or substance abuse judged by the Investigator to potentially interfere with compliance
15. Females who are pregnant or may wish to become pregnant during the study
16. If the Investigator believes the prospective subject will not be able to comply with the requirements of the protocol and complete the study
17. Any medical condition, in the opinion of the Investigator, that could interfere with evaluation of the study objectives or safety of the subjects
Exclusion Criteria for Extension Period Subjects who meet any of the following exclusion criteria are not to be enrolled into the Extension Period:
1. Any condition, comorbidity, or laboratory abnormality that, based on the package insert of tenofovir or in the opinion of the Investigator, excludes the subject
2. Subjects who were withdrawn from Part A or Part B due to an AE or serious adverse event (SAE) related to the use of tenofovir
3. Participation in any other interventional study
4. Subject fully terminated from Part A or Part B
The Estimated Number of Participants
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Taiwan
78 participants
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Global
360 participants
