HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB) (NCT04684914) | Clinical Trial Compass
TerminatedPhase 2
HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)
Stopped: Did not meet endpoints
United States87 participantsStarted 2020-12-26
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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).
What they're measuring
1
The Proportion of Patients Achieving Virologic Responses