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Trial record 138 of 311 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV (ACHIEVE)

This study is currently recruiting participants.
Verified May 2017 by Spring Bank Pharmaceuticals, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02751996
First Posted: April 26, 2016
Last Update Posted: May 9, 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):
Spring Bank Pharmaceuticals, Inc.
  Purpose
This is a Phase 2, open-label,randomized, multiple dose, varied administration regimen study with 2 parts (Parts A and B) in Subjects Infected with Chronic Hepatitis B Virus

Condition Intervention Phase
Hepatitis B Hepatitis, Viral Drug: SB 9200 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Spring Bank Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Part A: Number 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 number 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)

  • Part B: Number of subjects reporting an adverse event (AE) [ Time Frame: 12 weeks ]
    The primary endpoints for safety and efficacy in Part B is the number 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).


Secondary Outcome Measures:
  • Maximum observed plasma SB 9200 plasma concentration (Cmax) [ Time Frame: 0 - 24 hours ]
  • Area under the curve (AUC) of SB 9200 at 6, 12, 14, 16, and 24 weeks [ Time Frame: 0 - 24 hours ]
  • Change in HBeAg from baseline (0) to weeks 6,12, and 24 [ Time Frame: 6, 12 and 24 weeks ]
  • Change in HBV DNA from baseline (0) to weeks 6,12, and 24 [ Time Frame: 6, 12 and 24 weeks ]

Estimated Enrollment: 300
Study Start Date: May 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Part A Cohort 1: 25mg SB 9200
Part A Cohort 1: 25mg SB 9200. After 12 week 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 1: 25mg Placebo
Part A Cohort 1: 25mg Placebo. After 12 week 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 A Cohort 2: 50mg SB 9200
Part A Cohort 2: 50mg SB 9200. After 12 week 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 week 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 A Cohort 3: 100mg SB 9200
Part A Cohort 3: 100mg SB 9200. After 12 week 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 3: 100mg Placebo
Part A Cohort 3: 100mg Placebo. After 12 week 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 A Cohort 4: 200mg SB 9200
Part A Cohort 4: 200mg SB 9200. After 12 week 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 4: 200mg Placebo
Part A Cohort 4: 200mg Placebo. After 12 week 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 900 optimal dose 1
Part B: SB 9200 Optimal dose 1 from Part A alone. After receiving 12 week of this IP 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
Active Comparator: Part B: SB 900 optimal dose 2
Part B: SB 9200 Optimal dose 2 from Part A alone. After receiving 12 week of this IP 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
Active Comparator: Part B:"SB9200 dose1" with "tenofovir"
Part B: "SB 9200 Optimal dose 1" from Part A with "Tenofovir 300mg". After receiving 12 week of receiving both "SB 9200" and "Tenofovir" both medications will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir alone(current standard of care)
Drug: SB 9200
SB 9200
Other Name: SB9200
Active Comparator: Part B:"SB9200 dose2" with "tenofovir"
Part B: "SB 9200 Optimal dose 2" from Part A with "Tenofovir 300mg". After receiving 12 week of receiving both "SB 9200" and "Tenofovir" both medications will be stopped. From weeks 12 - 24 patients will be given 12 weeks of Tenofovir alone(current standard of care)
Drug: SB 9200
SB 9200
Other Name: SB9200
No Intervention: Part B: Tenofovir 300mg alone
Part B: 300mg Tenofovir alone. After receiving 12 weeks of Tenofovir, this medication will be stopped. From weeks 12-24 patients will be given 12 weeks of Tenofovir (Current standard of Treatment). Patients may be eligible for 52 weeks of Tenofovir

  Show Detailed Description

  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:

  1. Documented evidence of chronic HBV infection (e.g., 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 > 2,000 IU/mL for HBeAg-negative subjects and > 20,000 IU/mL for HBeAg-positive subjects at Screening
  4. ALT > ULN, but < 5 X the ULN and ≤ 150 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. Any medical condition, in the opinion of the Investigator, which could interfere with evaluation of the study objectives or safety of the subjects
  9. 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 Study:

  1. Signed informed consent form
  2. 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:

  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 variceal bleeding
  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 (WBC) < 4,000 cells/µL, hemoglobin (HgB) < 12 g/dL for females, < 13 g/dL for males, platelets < 150,000 per µL, albumin < 3.5 g/dL, international normalized ratio (INR) > 1.5, total bilirubin > 1.2 mg/dL, or alpha-fetoprotein (AFP) > 50 ng/mL. 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 less than 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, creatinine clearance (CrCl) < 50 mL/min
  6. Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV)
  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). Patients 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 (e.g., corticosteroids) or biologics (e.g., monoclonal antibody, IFN)
  12. Patients 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

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 which, 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.
  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): NCT02751996


Contacts
Contact: Donald Mitchell +1(508) 689-9737 dmitchell@springbankpharm.com

Locations
Canada, Alberta
Spring Bank Pharma Research site Recruiting
Calgary, Alberta, Canada
Canada, British Columbia
Spring Bank Pharma Research site Recruiting
Vancouver, British Columbia, Canada
Canada, Ontario
Spring Bank Pharma Research Site Recruiting
London, Ontario, Canada
Spring Bank Pharma Research site Recruiting
Toronto, Ontario, Canada
Spring Bank Pharma Research site Recruiting
Vaughan, Ontario, Canada
Hong Kong
Spring Bank Pharma Research site Recruiting
Hong Kong, Hong Kong
Spring Bank Pharma Research site Recruiting
Shatin, Hong Kong
Korea, Republic of
Spring Pharma Research Site Recruiting
Chuncheon-si, Gangwon-do, Korea, Republic of
Spring Bank Pharma Research site Recruiting
Yangsan-si, Gyeongsangnam-do, Korea, Republic of
Spring Bank Pharma Research site Recruiting
Busan, Korea, Republic of
Spring Bank Pharma Research Site Recruiting
Daegu, Korea, Republic of
Spring Bank Pharma Research site Recruiting
Goyang-si, Korea, Republic of
Spring Bank Pharma Research site Recruiting
Seoul, Korea, Republic of
Taiwan
Spring Bank Pharma Research Site Recruiting
Chia-Yi City, Taiwan
Spring Bank Pharma Research Site Recruiting
New Taipei City, Taiwan
Spring Bank Pharma Research Site Recruiting
Taipei, Taiwan
Spring Bank Pharma Research Site Recruiting
Taoyuan County, Taiwan
Sponsors and Collaborators
Spring Bank Pharmaceuticals, Inc.
Investigators
Study Director: Chelsea Macfarlane SBP Director of Clinical Operations
  More Information

Responsible Party: Spring Bank Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02751996     History of Changes
Other Study ID Numbers: SBP-9200-HBV-201
First Submitted: April 6, 2016
First Posted: April 26, 2016
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data at this stage

Keywords provided by Spring Bank Pharmaceuticals, Inc.:
Chronic Hepatitis
HBV
Double blind

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
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-Retroviral Agents
Anti-HIV Agents