Status:
TERMINATED
HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)
Lead Sponsor:
Altimmune, Inc.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A study to evaluate the antiviral effects, immunogenicity, and safety of HepTcell in treatment-naive patients with inactive chronic hepatitis B (CHB) and low hepatitis B surface antigen (HBsAg) levels...
Eligibility Criteria
Inclusion
- Men and women 18 to 65 years of age, inclusive
- Inactive CHB with documented HBsAg positivity for at least 12 months before Day 1
- qHBsAg ≥ 10 IU/mL but ≤ 100 IU/mL in the 12 months prior to screening
- HBV DNA ≥ 10 IU/mL at screening
- AST, ALT, INR, albumin, total bilirubin (excluding patients with Gilbert Syndrome) and direct bilirubin within normal limits at screening
Exclusion
- Positive hepatitis B e antigen (HBeAg) at screening
- History of a hepatitis B flare or 1-log increase in HBV DNA or HBsAg in the prior 12 months
- Undetectable HBV DNA at screening
- Fibroscan \> 8.5 kPA at screening, or history of hepatic fibrosis or cirrhosis (NB, a Fibroscan is not required if an examination is performed within 12 months or a liver biopsy was performed within 2 years before Screening and no fibrosis \[F1 or greater\] was identified).
Key Trial Info
Start Date :
December 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2024
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04684914
Start Date
December 26 2020
End Date
April 17 2024
Last Update
December 8 2025
Active Locations (21)
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1
Paragon Rx Clinical
Garden Grove, California, United States, 92840
2
Stanford University Department of Medicine
Redwood City, California, United States, 94063
3
San Jose Gastroenterology Institute
San Jose, California, United States, 95128
4
Kansas City Research Institute
Kansas City, Missouri, United States, 64131