ACTRN12624000808549
Not yet recruiting
Phase 1
A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod Alone and in Combinations in Subjects with Chronic Hepatitis B Infection
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis B Infection
- Sponsor
- Bluejay Therapeutics, Inc
- Enrollment
- 40
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female adults between 18 and 65 years of age, inclusive
- •2\. Chronic HBV infection greater than or equal to 6 months (e.g., positive for serum HBsAg greater than or equal to 6 months)
- •3\. Taking a commercially available nucleos(t)ide analogs for at least 2 months prior to Screening, and willing to remain on stable treatment for the duration of the study, unless they achieve nucleos(t)ide stopping criteria.
- •4\. HBV DNA less than 100 IU/mL in blood at Screening
- •5\. HBsAg at Screening:
- •a. Part A: greater than LLOQ
Exclusion Criteria
- •1\. Pregnant or nursing females
- •2\. Male or female subjects of childbearing potential unwilling to comply with contraception requirements during the study
- •3\. Fibroscan greater than or equal to 8\.5 kPa within 1 year of Screening
- •4\. History of and/or current decompensated liver disease as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal variceal bleeding
- •5\. Presence of liver disease, not including chronic HBV infection, such as nonalcoholic steatohepatitis (NASH), alcohol\-associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or HDV) or non\-viral hepatitis that has the potential to impact interpretation
- •of data. Exceptions to this criterion include fatty liver without any signs of steatohepatitis or past HCV infection that was successfully treated greater than or equal to 6 months prior to Screening.
- •6\. Positive for HIV, HDV, or HCV infection at Screening
- •7\. Received solid organ or bone marrow transplant
- •8\. Chronic systemic immunosuppressive therapy (e.g., prednisone) within 1 month of Screening or require the use of during the study.
- •9\. Prior or current history of hepatocellular carcinoma (HCC) or suspected HCC as evidenced by screening alpha\-fetoprotein greater than or equal to 20 ng/mL
Outcomes
Primary Outcomes
Not specified
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