A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV (ACHIEVE)
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ClinicalTrials.gov Identifier: NCT02751996 |
Recruitment Status :
Completed
First Posted : April 26, 2016
Last Update Posted : February 11, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B Hepatitis, Viral | Drug: SB 9200 Drug: Placebo Drug: Tenofovir | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | May 2016 |
Actual Primary Completion Date : | February 10, 2020 |
Actual Study Completion Date : | February 10, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Part A Cohort 1: 25mg SB 9200
Part A Cohort 1: 25mg SB 9200. After 12 weeks of SB 9200 this medication will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir (current standard of care)
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Drug: SB 9200
SB 9200
Other Name: SB9200 |
Placebo Comparator: Part A Cohort 1: 25mg Placebo
Part A Cohort 1: 25mg Placebo. After 12 weeks of Placebo this medication will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir (current standard of care)
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Drug: Placebo |
Active Comparator: Part A Cohort 2: 50mg SB 9200
Part A Cohort 2: 50mg SB 9200. After 12 weeks of SB 9200 this medication will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir (current standard of care)
|
Drug: SB 9200
SB 9200
Other Name: SB9200 |
Placebo Comparator: Part A Cohort 2: 50mg Placebo
Part A Cohort 2: 50mg Placebo. After 12 weeks of Placebo this medication will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir (current standard of care)
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Drug: Placebo |
Active Comparator: Part A Cohort 3: 100mg SB 9200
Part A Cohort 3: 100mg SB 9200. After 12 weeks of SB 9200 this medication will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir (current standard of care)
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Drug: SB 9200
SB 9200
Other Name: SB9200 |
Placebo Comparator: Part A Cohort 3: 100mg Placebo
Part A Cohort 3: 100mg Placebo. After 12 weeks of Placebo this medication will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir (current standard of care)
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Drug: Placebo |
Active Comparator: Part A Cohort 4: 200mg SB 9200
Part A Cohort 4: 200mg SB 9200. After 12 weeks of SB 9200 this medication will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir (current standard of care)
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Drug: SB 9200
SB 9200
Other Name: SB9200 |
Placebo Comparator: Part A Cohort 4: 200mg Placebo
Part A Cohort 4: 200mg Placebo. After 12 weeks of Placebo this medication will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir (current standard of care)
|
Drug: Placebo |
Active Comparator: Part B: SB 9200 with tenofovir
Part B: SB 9200 selected dose from Part A administered in combination with tenofovir 300 mg qd. After 12 weeks of SB 9200 this medication will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir (current standard of care)
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Drug: SB 9200
SB 9200
Other Name: SB9200 |
Active Comparator: Part B: Tenofovir 300 mg
Part B: Tenofovir 300 mg qd monotherapy. After 12 weeks of SB 9200 this medication will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir (current standard of care)
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Drug: Tenofovir |
- Part A: Proportion of subjects reporting an adverse event (AE) and HBV DNA decline [ Time Frame: 12 weeks ]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 (Randomisation) to end of SB 9200 treatment (12 weeks) and change from baseline to Week 12 in Log10 HBV DNA.
- Part B: Proportion of subjects reporting an adverse event (AE) and hepatitis B surface antigen decline [ Time Frame: 12 weeks ]The primary endpoints for safety and efficacy in Part B is the proportion of subjects reporting an adverse event (AE) or experiencing a clinically significant AE or laboratory abnormality from baseline (Randomisation) to end of SB 9200 treatment (12 weeks) and the proportion of subjects with hepatitis B surface antigen decline (12 weeks)
- Maximum observed plasma SB 9200 plasma concentration (Cmax) and determination of pharmacokineticPK parameters for SB 9200 and, Rp -SB 9000, and Sp SB 9000 (Parts A and B) [ Time Frame: 0 - 24 hours ]
- Change in serum HBV DNA, HBsAg, and HBV RNA at 2, 4, 8, 12, 14, and 24 weeks (Part A) [ Time Frame: 2, 4, 8, 12, 14, and 24 weeks ]
- Change in serum HBV DNA, HBsAg, and HBV RNA at 2, 4, 6, 12, 14, and 24 weeks (Part B) [ Time Frame: 2, 4, 6, 12, 14, and 24 weeks ]
- Change in HBeAg in log10 IU/mL from Baseline to Weeks 2, 4, 8, 12, 14, and 24 (Part A) [ Time Frame: Weeks 2, 4, 8, 12, 14, and 24 weeks ]
- Change in HBeAg in log10 IU/mL from Baseline to Weeks 2, 4, 6, 12, 14, and 24 (Part B) [ Time Frame: 2, 4, 6, 12, 14, and 24 weeks ]
- Proportion of subjects with HBeAg or HBsAg loss and seroconversion at Weeks 2, 4, 8, 12, 14, and 24 (Part A) [ Time Frame: 2, 4, 8, 12, 14, and 24 weeks ]
- Proportion of subjects with HBeAg or HBsAg loss and seroconversion at Weeks 2, 4, 6, 12, 14, and 24 (Part B) [ Time Frame: 2, 4, 6, 12, 14, and 24 weeks ]
- Proportion of subjects with HBsAg ≥ 1 log10 reduction from Baseline to Week 12 (Part B) [ Time Frame: 12 weeks ]

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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
- HBV DNA > 2000 IU/mL for HBeAg-negative subjects and > 20000 IU/mL for HBeAg-positive subjects at Screening
- ALT > ULN, but < 5 x the ULN and ≤ 200 U/L
- Ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 3 months of randomization date with no evidence of hepatocellular carcinoma
- Must be willing and able to comply with all study requirements
- 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.
- Must have the ability to understand and sign a written 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:
- Signed informed consent form
- Subject was randomized in Part A or Part B
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- Any prior liver biopsy evidence of metavir F3 or F4 disease
- Any history of decompensation of liver disease including history of ascites, encephalopathy, or varices
- 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.
- Laboratory parameters not within defined thresholds: white blood cells (WBC) < 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
- Creatinine > 1.2 mg/dL, (SI unit > 106.08 µmol/L), creatinine clearance < 50 mL/min, (SI unit < 0.83 L/s/m2)
- Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus
- Evidence or history of hepatocellular carcinoma
- 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.
- Significant cardiovascular, pulmonary, or neurological disease
- Received solid organ or bone marrow transplant
- Received within 3 months of Screening or expected to receive prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, IFN)
- 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
- Use of another investigational agent within 3 months of Screening
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with compliance
- Females who are pregnant or may wish to become pregnant during the study
- If the Investigator believes the prospective subject will not be able to comply with the requirements of the protocol and complete the study
- 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:
- Any condition, comorbidity, or laboratory abnormality that, based on the package insert of tenofovir or in the opinion of the Investigator, excludes the subject
- 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
- Participation in any other interventional study
- Subject fully terminated from Part A or Part B

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): NCT02751996
Canada, Alberta | |
Spring Bank Pharma Research site | |
Calgary, Alberta, Canada | |
Canada, British Columbia | |
Spring Bank Pharma Research site | |
Vancouver, British Columbia, Canada | |
Canada, Ontario | |
Spring Bank Pharma Research Site | |
London, Ontario, Canada | |
Spring Bank Pharma Research site | |
Toronto, Ontario, Canada | |
Spring Bank Pharma Research site | |
Vaughan, Ontario, Canada | |
Hong Kong | |
Spring Bank Pharma Research site | |
Hong Kong, Hong Kong | |
Spring Bank Pharma Research site | |
Shatin, Hong Kong | |
Korea, Republic of | |
Spring Pharma Research Site | |
Chuncheon-si, Gangwon-do, Korea, Republic of | |
Spring Bank Pharma Research site | |
Yangsan-si, Gyeongsangnam-do, Korea, Republic of | |
Spring Bank Pharma Research site | |
Busan, Korea, Republic of | |
Spring Bank Pharma Research Site | |
Daegu, Korea, Republic of | |
Spring Bank Pharma Research site | |
Goyang-si, Korea, Republic of | |
Spring Bank Pharma Research site | |
Seoul, Korea, Republic of | |
Taiwan | |
Spring Bank Pharma Research Site | |
Chia-Yi City, Taiwan | |
Spring Bank Pharma Research Site | |
New Taipei City, Taiwan | |
Spring Bank Pharma Research Site | |
Taipei, Taiwan | |
Spring Bank Pharma Research Site | |
Taoyuan County, Taiwan |
Study Director: | Chelsea Macfarlane | SBP Sr. Director of Clinical Operations |
Responsible Party: | F-star Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02751996 |
Other Study ID Numbers: |
SBP-9200-HBV-201 |
First Posted: | April 26, 2016 Key Record Dates |
Last Update Posted: | February 11, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No plan to share data at this stage |
Chronic Hepatitis HBV Double blind |
Hepatitis A Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections |
Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Tenofovir Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents |