HEPATITIS B CHRONIC study: PBGENE-HBV
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?
This is an investigational gene editing treatment being studied for chronic hepatitis B. It is designed to use gene editing to remove the main source of the virus and inactivate virus DNA in liver cells.
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 study aims to find out if the drug is safe, how the body handles it, and if it helps fight the hepatitis B virus.
- Who it's for
- Adults who have chronic hepatitis B.
- What's involved
- Participants will receive the study drug and undergo tests to check for side effects and measure the drug's activity in the body.
- Time commitment
- The source text does not specify the total duration or number of visits required.
- 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.
- 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 is enrolling
- Boston, Massachusetts, United States
- Clichy, France, France
- Hong Kong, Hong Kong, Hong Kong
- Chisinau, Moldova
- Auckland, New Zealand
- Bucharest, Romania, Romania
- Cluj-Napoca, Romania, Romania
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, but 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?
This study is enrolling now at Boston, Massachusetts, United States; Clichy, France, France; Hong Kong, Hong Kong, Hong Kong; Chisinau, Moldova; Auckland, New Zealand; Bucharest, Romania, Romania and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.