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MinorEnrollment closed, study ongoingFinal enrollment: 12 participants (planned 50) · Eligibility criteria expanded, about 30 words · Site details revisedShow 3 more changesShow less
Final enrollment: 12 participants (planned 50)
Eligibility criteria expanded, about 30 words
Site details revised
Minor3 versionsRe-verified since Jul 23, 2026, no change to tracked fieldsv307-v309
MinorStudy Status, Eligibilityv306
Minor20 versionsRe-verified since Mar 7, 2025, no change to tracked fieldsv286-v305
MinorStart date changed from estimate of Feb 9, 2025 to Jan 31, 2025v285
Show 24 earlier versionsHide 24 earlier versions
MinorStart date: Feb 6, 2025 to Feb 9, 2025v284
MinorStart date: Feb 5, 2025 to Feb 6, 2025v283
MinorStart date: Feb 4, 2025 to Feb 5, 2025v282
MinorStart date: Feb 3, 2025 to Feb 4, 2025v281
MinorStart date: Feb 2, 2025 to Feb 3, 2025v280
MinorStart date: Jan 30, 2025 to Feb 2, 2025v279
MinorStart date: Jan 29, 2025 to Jan 30, 2025v278
MinorStart date: Jan 28, 2025 to Jan 29, 2025v277
MinorStart date: Jan 27, 2025 to Jan 28, 2025v276
MinorStart date: Jan 22, 2025 to Jan 27, 2025v275
MinorStart date: Jan 21, 2025 to Jan 22, 2025v274
MinorStart date: Jan 20, 2025 to Jan 21, 2025v273
MinorStart date: Jan 19, 2025 to Jan 20, 2025v272
MinorStart date: Jan 16, 2025 to Jan 19, 2025v271
MinorStart date: Jan 15, 2025 to Jan 16, 2025v270
NotableTrial status: Not Yet Recruiting to RecruitingPrimary completion date: Jun 30, 2025 to Feb 29, 2028 · Completion date: Jun 30, 2026 to Aug 31, 2028 · Start date: Jan 14, 2025 to Jan 15, 2025v269Show 3 more changesShow less
Primary completion date: Jun 30, 2025 to Feb 29, 2028
Completion date: Jun 30, 2026 to Aug 31, 2028
Start date: Jan 14, 2025 to Jan 15, 2025
MinorStart date: Jan 13, 2025 to Jan 14, 2025v268
MinorStart date: Jan 12, 2025 to Jan 13, 2025v267
MinorStart date: Jan 9, 2025 to Jan 12, 2025v266
MinorStart date: Jan 8, 2025 to Jan 9, 2025v265
MinorStart date: Jan 6, 2025 to Jan 8, 2025v264
MinorStart date: Jan 5, 2025 to Jan 6, 2025v263
MinorStart date: Jan 2, 2025 to Jan 5, 2025v262
MinorStart date: Jan 1, 2025 to Jan 2, 2025v261
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.