Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects

Completed · Phase 1

Conditions studied: Hepatitis B

In brief

This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen \[HBsAg\] and Hepatitis B core antigen \[HBcAg\]) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated participants.

Key facts

Study ID

NCT02431312

Run by

Inovio Pharmaceuticals

People needed

90

Starts

2015-01-12

Expected to finish

2018-05-22

Last updated by the study team

2019-10-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic Hepatitis B virus infection
• 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

You may not qualify if…

• Pregnant or breastfeeding females
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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