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Trial record 94 of 314 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Inovio Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02431312
First received: April 21, 2015
Last updated: September 8, 2016
Last verified: September 2016
  Purpose
This is an open-label study to evaluate the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding HBsAg and HBcAg) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated patients.

Condition Intervention Phase
Hepatitis B Biological: Group A: INO-1800 alone delivered by EP Biological: Group B: INO-1800 + INO-9112 delivered by EP Drug: Nucleos(t)ide Analogue Treatment Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I, Randomized, Open-Label, Active-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability & Immunogenicity of INO-1800 Alone or in Combination With INO-9112 Delivered IM Followed by EP in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients

Resource links provided by NLM:


Further study details as provided by Inovio Pharmaceuticals:

Primary Outcome Measures:
  • Safety Assessment (Composite of multiple measures: pain (VAS), adverse events, lab abnormalities, changes in vital signs) [ Time Frame: Signing of ICF through up to 76 weeks following the first dose ]

    Composite outcome measure consisting of multiple measures, including:

    1. 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"
    2. Frequency and severity of local and systemic events for at least 7 days after Study Treatment/EP
    3. Frequency and severity of laboratory abnormalities
    4. Frequency and severity of all adverse events
    5. Changes in vital signs


Secondary Outcome Measures:
  • Immunogenicity Assessment [ Time Frame: Baseline (screening and first dose) and select points up to 76 weeks after the first dose ]

    Composite outcome measure consisting of multiple measures, including

    1. Breadth and Magnitude of antigen specific cellular immune responses

      • Interferon-ɣ ELISpot
      • Flow Cytometry for T-cell activation, cytolytic phenotype, memory phenotype
    2. Breadth and Magnitude of antigen specific ELISA

  • Viral/Antiviral Assessment [ Time Frame: Screening and/or first dose and select points up to 76 weeks after the first dose ]

    Composite outcome measure consisting of multiple measures, including:

    1. Evaluate effect on HBsAg kinetics as measured in the quantitative HBsAg assay
    2. Evaluate effect on maintenance of HBV DNA suppression (< 90 IU/ml) as measured in the quantitative viral load assay


Other Outcome Measures:
  • Exploratory Assessment [ Time Frame: Screening and/or first dose and select points up to 76 weeks after the first dose ]

    Composite outcome measure consisting of multiple measures, including:

    1. Relationship between immunogenicity and antiviral response
    2. Expression of individual markers potentially predictive of immunogenic and antiviral responses


Estimated Enrollment: 90
Study Start Date: January 2015
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A, low dose, standard regimen
0.3mg INO-1800 delivered by EP in a standard regimen (either 3 or 4 doses) while continuing treatment with nucleos(t)ide analogue treatment
Biological: Group A: INO-1800 alone delivered by EP
Experimental: Group A, mid dose, standard regimen
2mg INO-1800 delivered by EP in a standard regimen (either 3 or 4 doses) while continuing treatment with nucleos(t)ide analogue treatment
Biological: Group A: INO-1800 alone delivered by EP
Experimental: Group A, high dose, standard regimen
9mg INO-1800 delivered by EP in a standard regimen (either 3 or 4 doses) while continuing treatment with nucleos(t)ide analogue treatment
Biological: Group A: INO-1800 alone delivered by EP
Experimental: Group B, mid dose, standard regimen
2mg INO-1800 + 0.25mg INO-9112 delivered by EP in a standard regimen (either 3 or 4 doses) while continuing treatment with nucleos(t)ide analogue treatment
Biological: Group B: INO-1800 + INO-9112 delivered by EP
Experimental: Group B, high dose, standard regimen
9mg INO-1800 + 0.25mg INO-9112 delivered by EP in a standard regimen (either 3 or 4 doses) while continuing treatment with nucleos(t)ide analogue treatment
Biological: Group B: INO-1800 + INO-9112 delivered by EP
Active Comparator: Active Control
Continue treatment with nucleos(t)ide analogue treatment
Drug: Nucleos(t)ide Analogue Treatment
Continue treatment with Nucleos(t)ide Analogue Treatment

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 mon 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
  • 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 mon prior to randomization
  • Screening laboratory values within normal range
  • ALT ≤1.5x ULN from 2 measurements separated by at least 14 days during the 6 mon 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 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 greater than 13 ng/mL
  • Prior history or current malignancy other than adequately treated BCC, unless history of BCC is near dintended 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02431312

Contacts
Contact: Mandeep Kaushal + 61 (0) 3 8401 3797 mandeep.kaushal@quintiles.com
Contact: Rajane Orilla + 919-230-3366 rajane.orilla@quintiles.com

  Show 31 Study Locations
Sponsors and Collaborators
Inovio Pharmaceuticals
Investigators
Study Director: Scott White, MD Inovio Pharmaceuticals
  More Information

Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02431312     History of Changes
Other Study ID Numbers: HBV-001
Study First Received: April 21, 2015
Last Updated: September 8, 2016

Keywords provided by Inovio Pharmaceuticals:
Chronic HBV
immunotherapy
DNA vaccine
electroporation

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on August 16, 2017