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Tests treatment safety and results for Hepatitis B Virus Infection
Official title A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection
ClinicalTrials.gov ID: NCT07024641
What this study is testing
What is GIGA-2339?
GIGA-2339 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatitis b virus infection.
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
- The primary purpose of this study is to assess the safety and tolerability of single and multiple intravenous (IV) doses of GIGA-2339 in participants with chronic Hepatitis B Virus (HBV) infection.
- 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 and older
You may be able to join if
- Hepatitis B envelope antigen (HBeAg) negative chronic HBV infection for ≥ 6 months, defined as presence of Hepatitis B surface antigen (HBsAg) in...
- Serum HBsAg concentration between ≥ 100 international units per milliliter (IU/mL) and 2000 IU/mL at screening.
- Currently on stable dose of nucleot(s)ide analogues (NAs) (≥ 6 months) and expected to continue while participating in the study, or are not received...
- Have serum HBV deoxyribonucleic acid (DNA) concentration ≤ 50 IU/mL at screening (for those who are on NAs); or have serum HBV DNA concentration ≤...
- Male participants must refrain from donating spermatozoa and agree to use highly effective contraception.
You likely can't join if
- Positive for co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), and/or hepatitis D virus (HDV) at screening.
- Participants that weigh less than 50 kilograms (kg) and/or have a body mass index (BMI) less than 18.5.
- History of documented liver cirrhosis at screening. Patients under liver cirrhosis evaluation at screening will not be eligible until cirrhosis is...
- Liver stiffness \> 8 kilopascal (kPa) at screening.
- History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would...
- Family history of hepatocellular carcinoma (HCC).
See the full eligibility criteria
- Hepatitis B envelope antigen (HBeAg) negative chronic HBV infection for ≥ 6 months, defined as presence of Hepatitis B surface antigen (HBsAg) in serum for ≥ 6 months.
- Serum HBsAg concentration between ≥ 100 international units per milliliter (IU/mL) and 2000 IU/mL at screening.
- Currently on stable dose of nucleot(s)ide analogues (NAs) (≥ 6 months) and expected to continue while participating in the study, or are not received NAs.
- Have serum HBV deoxyribonucleic acid (DNA) concentration ≤ 50 IU/mL at screening (for those who are on NAs); or have serum HBV DNA concentration ≤ 2000 IU/mL at screening (for those who are NOT on NAs).
- Male participants must refrain from donating spermatozoa and agree to use highly effective contraception.
- Female participants must not be pregnant, or breastfeeding; either should not be a woman of childbearing potential (WOCBP) or if WOCBP should use highly effective contraceptive methods. Key
- Positive for co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), and/or hepatitis D virus (HDV) at screening.
- Participants that weigh less than 50 kilograms (kg) and/or have a body mass index (BMI) less than 18.5.
- History of documented liver cirrhosis at screening. Patients under liver cirrhosis evaluation at screening will not be eligible until cirrhosis is ruled out.
- Liver stiffness \> 8 kilopascal (kPa) at screening.
- History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would preclude participation.
- Family history of hepatocellular carcinoma (HCC).
- Alpha fetoprotein \> 20 nanograms per milliliter (ng/mL).
- Presence of a liver imaging reporting and data system (LI-RADS) 4 or 5 liver lesion on imaging 12 months prior to Screening OR, LI-RADS-US findings of US-3 grade on imaging 12 months prior to Screening, OR LIRADS-US...
- History of hematopoietic stem cell transplant or solid organ transplant.
- Receipt of anti-HBV monoclonal antibody (mAb)/pAb therapy of any kind in the past (including hepatitis B immunoglobulin [HBIG]).
- History of cardiovascular disease (e.g., coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome). Stable hypertension is allowed.
- Malignancy diagnosed and/or treated within 5 years prior to Screening, and/or with ongoing treatment for malignancy, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or...
- Participants requiring anti-coagulation therapies (for example warfarin, Factor Xa inhibitors, or anti-platelet agents like clopidogrel).
- Male participants with a corrected QT interval using Fridericia's formula (QTcF) \> 450 milliseconds (msec) and female participants with QTcF \> 470 msec on ECG recorded at screening. if the participant has evidence of...
- Known hypersensitivity to any GIGA-2339 excipients or any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (nonactive hay fever is acceptable), or a...
- Received or will receive live-attenuated virus vaccinations such as measles, mumps, rubella or varicella within 4 weeks before and up to three months after administration of investigational product (IP).
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Huntington Beach, California, United States
- Lake Forest, California, United States
- Long Beach, California, United States
- Oakland, California, United States
- Peachtree Corners, Georgia, United States
- Iowa City, Iowa, United States
- Lenexa, Kansas, United States
- Baltimore, Maryland, United States
- San Antonio, Texas, United States
- Webster, Texas, United States
- Richmond, Virginia, United States
- Concord, New South Wales, Australia
- Fortitude Valley, Queensland, Australia
- Hong Kong, Hong Kong Island, Hong Kong
- Shatin, New Territories, Hong Kong
- Seogu, Busan, South Korea
- Songpa-dong, Seoul, South Korea
- Sanmin, Kaohsiung, Taiwan
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Huntington Beach, California, United States; Lake Forest, California, United States; Long Beach, California, United States; Oakland, California, United States; Peachtree Corners, Georgia, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.