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Tests treatment safety and results for HEPATITIS B CHRONIC
Official title Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT06680232
What this study is testing
What is PBGENE-HBV?
PBGENE-HBV is an investigational medicine, being studied as a potential treatment for hepatitis b chronic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Male or women of non-child bearing potential
- BMI 18.0 to 35.0
- Good overall health deemed by the study Investigator
- CHB infection documented at least 12 months prior to screening
- HBeAg-negative CHB
You likely can't join if
- No history of cirrhosis of the liver
- No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition...
- No signs of hepatocellular carcinoma
- Not received an organ transplant
- No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)
- No investigational agent received within 6 months of screening
See the full eligibility criteria
- Male or women of non-child bearing potential
- BMI 18.0 to 35.0
- Good overall health deemed by the study Investigator
- CHB infection documented at least 12 months prior to screening
- HBeAg-negative CHB
- Must be virologically suppressed on current NA treatment Key
- No history of cirrhosis of the liver
- No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.
- No signs of hepatocellular carcinoma
- Not received an organ transplant
- No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)
- No investigational agent received within 6 months of screening
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Hong Kong, Hong Kong, Hong Kong
- Chisinau, Moldova
- Auckland, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Hong Kong, Hong Kong, Hong Kong; Chisinau, Moldova; Auckland, New Zealand. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.