Is NCT06092333 recruiting in Bethesda, MD?

Yes, NCT06092333 is currently recruiting participants at its Bethesda, MD location. This chronic hepatitis b clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Bethesda, 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 Bethesda 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 Bethesda, MD

About This Chronic Hepatitis B Study in Bethesda

Background: Chronic hepatitis B virus (HBV) infection affects 292 million people worldwide; 887,000 die each year from cirrhosis, liver cancer, and related issues. Treatment options are limited. Objective: To test 2 drugs (VIR-2218 and peginterferon) in people with mild or inactive HBV infection. Eligibility: People aged 18 to 65 years with mild or inactive HBV infection. Design: Participants will be screened. They will have blood tests and an eye exam. They will have imaging scans of the liver to check the health of the liver. Participants will be in the study for over 2 years. VIR-2218 is an injection given under the skin of the stomach, upper arm, or thigh. Participants will come to the clinic to receive this injection once a month for 6 months. Peginterferon is also injected under the skin. Participants will have this shot once a week for 6 months. They may either inject themselves at home or come to the clinic to get the injections. Participants will get just the VIR-2218 for 3 months, then both shots for 3 months, then just the peginterferon for 3 months. Participants will have two 3-day stays in the hospital. Tests will include: Liver biopsy. A sample of tissue will be taken from their liver. After the procedure, participants will lie on their right side for 2 hours and then on their back for 4 hours. Fine needle aspiration. A small needle will be used to collect cells from the liver. After the last injection of peginterferon, follow-up visits will continue in the outpatient clinic every 4 to 12 weeks.

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who Can Participate

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Age \>=18-65 years

HBsAg positive with a level \<2,000 IU/mL at the time of screening

Hepatitis B e antigen negative

HBV DNA levels \<10,000 IU/mL on two occasions at least 24 weeks apart with the second being at time of screening

ALT level \<=2 ULN (using sex-specific cut-offs of normal 35 U/L for males and 25 U/L for females) based on at least two determinations taken at least 24 weeks apart with the second being at time of screening

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

Pregnancy or lactation

For women of childbearing potential, inability, or unwillingness to use highly effective contraception during study drug dosing and for an additional 24 weeks after the end of study drug administration.

For males of reproductive potential: Unable or unwilling to use condoms consistently in addition to female partner using another adequate contraceptive method to ensure effective contraception with partner during study participation and for an additional 24 weeks after the end of study medication administration. Patients who have underwent surgical sterilization (vasectomy) will still require female partner to utilize an additional adequate contraception method.

Known history of hypersensitivity or contraindication to an siRNA, oligonucleotide, or GalNAc or any interferon product

Current use of oral theophylline and methadone

Any treatment for HBV within the last 24 weeks

Prior exposure to a siRNA

Co-infection with HDV as defined by the presence of anti-HDV in serum.

Co-infection with HCV as defined by the presence of anti-HCV and HCV RNA in serum.

Co-infection with HIV as defined by the presence of anti-HIV in serum

Cirrhosis either diagnosed by a prior liver biopsy at any time or, if not available, by a transient elastography score \>13 kPa

Decompensated liver disease as defined by serum bilirubin \>2.5 mg/dL (with direct bilirubin \> 1.5 mg/dL), prothrombin time of greater than 2 seconds prolonged, a serum albumin of less than 3.5 g/dL, or a history of ascites, variceal bleeding or hepatic encephalopathy

Hepatocellular carcinoma (HCC), or the presence of a mass on imaging studies of the liver that is suggestive of HCC, or an alpha-fetoprotein level of greater than 500 ng/mL

Presence of other causes of liver disease, (i.e. hemochromatosis, Wilson disease, alcoholic liver disease, severe steatosis, alpha-1-anti-trypsin deficiency)

A history of solid organ or bone marrow transplant

Any current medical condition requiring the chronic use of more than 10 mg of prednisone (or its equivalent) daily or biologics (e.g. monoclonal antibody, interferon) within 3 months of screening.

Significant systemic illness other than liver diseases including congestive heart failure, renal failure, chronic pancreatitis and diabetes mellitus with poor control (hemoglobin A 1C (HgbA1C \>8.5)), that in the opinion of the investigator may interfere with therapy.

eGFR \< 60 ml/min, serum creatinine \> 1.3 mg/dl

Platelet count \<90 mm3/dL

Hgb \<12 g/dL for males and \<11 g/dL for females

White Blood cell count \< 2500 cells/mm3

Neutrophil count \< 1500 cell/mm3 (or \< 1000 cell/mm3 if considered a physiological variant in a subject of African descent)

Active ethanol/drug abuse/psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study.

History of malignancy or treatment for a malignancy within the past 3 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin).

History of immune-mediated disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis, sarcoidosis, psoriasis of greater than mild severity, autoimmune uveitis), or cerebrovascular, chronic pulmonary or cardiac disease associated with functional limitation, retinopathy, uncontrolled thyroid disease, (TSH \>10 or \<0.4mU/L) or uncontrolled seizure disorder, as determined by a study physician.

Use of another investigational agent within 90 days of screening

Use of any prohibited immunosuppressants (except short term use of prednisone as a steroid burst \[\<= 1 week of use\]) or cytotoxic medications

Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study.

Inability of subject to understand and the unwillingness to sign a written informed consent document

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 Bethesda?

Yes, this clinical trial (NCT06092333) has an active research site in Bethesda, 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 Bethesda, MD

If you're searching for chronic hepatitis b treatment options in Bethesda, MD, this clinical trial (NCT06092333) 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 Bethesda 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 Bethesda, MD

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