Is NCT06154278 recruiting in Baltimore, MD?

Yes, NCT06154278 is currently recruiting participants at its Baltimore, MD location. This chronic hepatitis b clinical trial is actively enrolling qualified participants.

How do I join the chronic hepatitis b clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chronic Hepatitis B Clinical Trial in Baltimore, MD

About This Chronic Hepatitis B Study in Baltimore

The goal of this clinical trial is to learn about the action of Imdusiran (AB-729) in the liver of people with chronic hepatitis B. The main questions it aims to answer are: * how well is it working in the liver * how does Imdusiran affect the hepatitis B virus Participants will receive injections of Imdusiran, one injection every 8 weeks, for a total of 4 doses. They will also undergo 2 liver biopsies: one with the first dose of Imdusiran, and the second 8 weeks after the last dose of Imdusiran.

Sponsor: University of Maryland, Baltimore

Who Can Participate

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, over 18 years of age on the date of screening

In good general health as evidenced by medical history

Documented evidence of chronic hepatitis B infection (HBsAg positive at screening and for at least more than 6 months prior to screening)

For females of reproductive potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline prior to study drug administration

Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Have been on commercially available HBV oral antiviral treatment(s) for at least 6 months and willing to continue through the final study visit.

HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to Screening.

Hepatitis B surface antigen titer ≥ 100 IU/mL.

Liver imaging without liver mass suggestive of hepatocellular carcinoma within 12 months of day 0 AND Alpha fetoprotein \<10 ng/mL within 3 months of screening.

Exclusion Criteria

Known co-infection with any of the following:

Human immunodeficiency virus (HIV)

Hepatitis C virus (HCV), unless subjects are HCV Ab positive, but have a documented history of completing HCV treatment and/or negative HCV RNA

Hepatitis D virus (HDV)

Any known preexisting medical or psychiatric condition that could interfere with the subject's ability to provide informed consent or participate in study conduct, or that may confound study

History of cirrhosis at any time, or evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding esophageal varices, hepatorenal syndrome, liver transplantation and/or hepatic encephalopathy.

Liver ultrasound or other imaging with findings suggestive of hepatocellular carcinoma (HCC) at any time.

Clinically unstable medical condition ≤2 weeks prior to the first dose of study treatment.

Clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine within the past 12 months except for those subjects monitored in an opioid substitution maintenance program.

Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g. basal cell skin cancer). Subjects under evaluation for possible malignancy are not eligible.

Extensive bridging fibrosis or cirrhosis as defined clinically, by imaging or by the following: a. Metavir ≥ 3 or Ishak fibrosis score ≥ 4 by a liver biopsy within 3 years of screening, or, in the absence of an appropriate liver biopsy, either: i. Screening FibroTest score \>0.48 and APRI \>1, or ii. FibroScan with a result \>9 kPa within 12 months of screening

If liver biopsy is available, the liver biopsy result supersedes (i) and (ii).

Subjects meeting any of the following laboratory parameters at screening:

Alanine aminotransferase (ALT) \>3x Upper Limit of Normal (ULN)

Direct bilirubin (if total bilirubin elevated) \>1.5 × ULN of the laboratory reference range.

Prothrombin (PT) or Activated Partial Thromboplastin Clotting Time (APTT) over the upper limit of normal.

Platelet count \<100,000/microliters

Estimated glomerular filtration rate, calculated by the chronic kidney disease epidemiology collaboration formula: \<60 mL/min/1.73 m2

Significant cardiovascular, pulmonary, or neurological disease in the opinion of the investigator.

Participation in any investigational drug, vaccine, or device study within 30 days before study treatment administration, or 90 days for a biologic study, or at any time during participation in the study.

Pregnancy or lactation

Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT06154278) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Hepatitis B Treatment Options in Baltimore, MD

If you're searching for chronic hepatitis b treatment options in Baltimore, MD, this clinical trial (NCT06154278) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic hepatitis b specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic hepatitis b clinical trials near you to find additional studies recruiting in your area.

Chronic Hepatitis B Clinical Trial in Baltimore, MD

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