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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02431312
Other study ID # HBV-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 12, 2015
Est. completion date May 22, 2018

Study information

Verified date October 2019
Source Inovio Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 22, 2018
Est. primary completion date May 22, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility INCLUSION CRITERIA:

- 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

EXCLUSION CRITERIA:

- 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)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
INO-1800
INO-1800 delivered by EP
INO-9112
INO-9112 delivered by EP
Drug:
Nucleos(t)ide Analogue Treatment
Continued treatment with nucleos(t)ide analogue

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Nepean Hospital Kingswood New South Wales
Australia Mater Adult Hospital South Brisbane Queensland
Hong Kong The University of Hong Kong Hong Kong
New Zealand Auckland City Hospital Auckland
Philippines The Medical City Pasig City
Singapore Singapore General Hospital Singapore
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan Chang Gung Memorial Hospital Linkou Taoyuan County
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Thailand Siriraj Hospital, Mahidol University Bangkoknoi Bangkok
Thailand Srinagarind Hospital Khon Kaen Muang District
Thailand Maharaj Nakorn Chiang Mai Hospital Tha Muang Chiang Mai
United States UC Physicians Company, LLC/Division of Digestive Diseases Cincinnati Ohio
United States Northwell Health Manhasset New York
United States University of Miami Schiff Center for Liver Disease Miami Florida
United States Mount Sinai - PRIME New York New York
United States Philadelphia VA Medical Center Philadelphia Pennsylvania
United States Research and Education, Inc. San Diego California
United States Harbourview Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Inovio Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Hong Kong,  New Zealand,  Philippines,  Singapore,  Taiwan,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory Assessment Composite outcome measure consisting of multiple measures, including:
Relationship between immunogenicity and antiviral response
Expression of individual markers potentially predictive of immunogenic and antiviral responses
Screening and/or first dose and select points up to 76 weeks after the first dose
Primary Safety Assessment (Composite of multiple measures: pain (VAS), adverse events, lab abnormalities, changes in vital signs) Composite outcome measure consisting of multiple measures, including:
Local pain immediately after Study Treatment/EP and at select times using a visual analog scale (VAS) from 0 to 10, with 0 representing "No Pain" and 10 representing "Worst Pain"
Frequency and severity of local and systemic events for at least 7 days after Study Treatment/EP
Frequency and severity of laboratory abnormalities
Frequency and severity of all adverse events
Changes in vital signs
Signing of ICF through up to 76 weeks following the first dose
Secondary Immunogenicity Assessment Composite outcome measure consisting of multiple measures, including
Breadth and Magnitude of antigen specific cellular immune responses
Interferon-? ELISpot
Flow Cytometry for T-cell activation, cytolytic phenotype, memory phenotype
Breadth and Magnitude of antigen specific ELISA
Baseline (screening and first dose) and select points up to 76 weeks after the first dose
Secondary Viral/Antiviral Assessment Composite outcome measure consisting of multiple measures, including:
Evaluate effect on HBsAg kinetics as measured in the quantitative HBsAg assay
Evaluate effect on maintenance of HBV DNA suppression (< 90 IU/ml) as measured in the quantitative viral load assay
Screening and/or first dose and select points up to 76 weeks after the first dose
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