Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects
NCT ID: NCT02431312
Last Updated: 2019-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
90 participants
INTERVENTIONAL
2015-01-12
2018-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Group A: low dose, standard regimen
Participants received 3 or 4 doses of 0.3 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment.
INO-1800
INO-1800 delivered by EP
Nucleos(t)ide Analogue Treatment
Continued treatment with nucleos(t)ide analogue
Group A: mid dose, standard regimen
Participants received 3 or 4 doses of 2 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment.
INO-1800
INO-1800 delivered by EP
Nucleos(t)ide Analogue Treatment
Continued treatment with nucleos(t)ide analogue
Group A: high dose, standard regimen
Participants received 3 or 4 doses of 9 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment.
INO-1800
INO-1800 delivered by EP
Nucleos(t)ide Analogue Treatment
Continued treatment with nucleos(t)ide analogue
Group B: mid dose, standard regimen
Participants received 3 or 4 doses of 2 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment.
INO-1800
INO-1800 delivered by EP
INO-9112
INO-9112 delivered by EP
Nucleos(t)ide Analogue Treatment
Continued treatment with nucleos(t)ide analogue
Group B: high dose, standard regimen
Participants received 3 or 4 doses of 9 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment.
INO-1800
INO-1800 delivered by EP
INO-9112
INO-9112 delivered by EP
Nucleos(t)ide Analogue Treatment
Continued treatment with nucleos(t)ide analogue
Active Control: nucleos(t)ide analogue treatment
Participants continued treatment with nucleos(t)ide analogue treatment.
Nucleos(t)ide Analogue Treatment
Continued treatment with nucleos(t)ide analogue
Interventions
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INO-1800
INO-1800 delivered by EP
INO-9112
INO-9112 delivered by EP
Nucleos(t)ide Analogue Treatment
Continued treatment with nucleos(t)ide analogue
Eligibility Criteria
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Inclusion Criteria
* Negative for Hepatitis A IgM, C, D and HIV
* Liver biopsy, Fibroscan® or equivalent elastography-based test obtained within the past 6 months demonstrating liver disease without evidence of bridging fibrosis or cirrhosis supported by platelet count greater than the central laboratory LLN at screening
* Positive for Hepatitis B surface antigen (≥250 IU/mL at screening)
* Nucleos(t)ide treatment for at least 1 year with ongoing nucleos(t)ide analogue treatment at randomization
* HBV DNA \<90 IU/mL for ≥6 months prior to randomization
* Screening laboratory values within normal range
* ALT ≤1.5x upper limit of normal (ULN) from 2 measurements separated by at least 14 days during the 6 months prior to randomization and ALT at screening ≤1.5x ULN
* AST, TBili, DBili, GGT, Alk Phos and albumin within normal range or judged to be not clinically significant by PI and medical monitor at screening
* For men and women who are not postmenopausal \[i.e. ≥ 12 months of non-therapy-induced amenorrhea, confirmed by follicle stimulating hormone (FSH), if not on hormone replacement\] or surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females) agreement to remain abstinent or use 1 highly effective or combined contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and at least through week 12 after last dose
Exclusion Criteria
* Positive serum pregnancy test at screening or positive urine pregnancy test at randomization
* Use of topical corticosteroids at or near the intended administration site
* Autoimmune disorders, transplant recipients, other immunosuppression including any concurrent condition requiring the use of immunosuppressive/immunomodulating agents (eye drop-containing and infrequent inhaled corticosteroids are permissible)
* Need for systemic antiviral treatment (other than for chronic hepatitis B infection)
* Documented history or other evidence of decompensated liver disease (e.g., ascites, bleeding from esophageal varices, Child-Pugh clinical classification B or C)
* History of liver cirrhosis demonstrated by biopsy, Fibroscan® or equivalent elastography-based test
* History of other evidence of a medical condition associated with chronic liver disease \[e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis (NASH), toxin exposure, thalassemia, etc.\]
* Documented history or other evidence of metabolic liver disease within 1yr of randomization
* Abnormal renal function including serum creatinine \>ULN or calculated creatinine clearance \<70 mL/min (using the Cockcroft Gault formula)
* History of or suspicion of HCC
* Screening alpha fetoprotein ≥13 ng/mL
* Prior history or current malignancy other than adequately treated BCC, unless history of BCC is near intended administration site
* History of significant medical conditions \[e.g., cardiac (including ventricular or supraventricular arrhythmias), renal disease, pulmonary, gastrointestinal, neurological\]
* Significant acute infection (e.g., influenza, local infection) or any other clinically significant illness within 2 weeks of randomization
* Administration of any blood product within 3 mon of randomization
* History of seizures (unless seizure free for 5yrs)
18 Years
65 Years
ALL
No
Sponsors
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Inovio Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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ShuPing Yang, MD, PhD
Role: STUDY_DIRECTOR
Inovio Pharmaceuticals
Locations
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Research and Education, Inc.
San Diego, California, United States
University of Miami Schiff Center for Liver Disease
Miami, Florida, United States
Northwell Health
Manhasset, New York, United States
Mount Sinai - PRIME
New York, New York, United States
UC Physicians Company, LLC/Division of Digestive Diseases
Cincinnati, Ohio, United States
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States
Harbourview Medical Center
Seattle, Washington, United States
Nepean Hospital
Kingswood, New South Wales, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The University of Hong Kong
Hong Kong, , Hong Kong
Auckland City Hospital
Auckland, , New Zealand
The Medical City
Pasig, , Philippines
Singapore General Hospital
Singapore, , Singapore
Chang Gung Memorial Hospital
Linkou District, Taoyuan County, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
Tha Muang, Chiang Mai, Thailand
Srinagarind Hospital
Khon Kaen, Muang District, Thailand
Countries
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Other Identifiers
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HBV-001
Identifier Type: -
Identifier Source: org_study_id
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