Chronic Hepatitis B Clinical Trial
Official title:
A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)
| Verified date | February 2024 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objectives of this study are to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieve functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV)deoxyribonucleic acid (DNA) < lower limit of quantitation (LLOQ) at Follow-up (FU) Week 24 in participants with chronic hepatitis B (CHB).
| Status | Active, not recruiting |
| Enrollment | 103 |
| Est. completion date | July 2024 |
| Est. primary completion date | January 23, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Key Inclusion Criteria: - Willing and able to provide informed consent - Chronic HBV infection for at least 6 months - Willing to follow protocol-specified contraception requirement Key Exclusion Criteria: - Have extensive fibrosis or cirrhosis in the liver - Have or had liver cancer (hepatocellular carcinoma) - Have an autoimmune disease - Have chronic liver disease other than HBV - Females who are breastfeeding, pregnant, or who wish to become pregnant during the study Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Liverpool Hospital | Liverpool | New South Wales |
| Australia | Royal Melbourne Hospital | Parkville | Victoria |
| Denmark | Aalborg University Hospital | Aalborg | |
| Denmark | Aarhus University Hospital | Aarhus N | |
| Denmark | Hvidovre Hospital | Hvidovre | |
| Denmark | Odense University Hospital | Odense | |
| Hong Kong | Princess Margaret Hospital (Hong Kong) | Hong Kong | |
| Hong Kong | Queen Mary Hospital | Hong Kong | |
| Hong Kong | Prince of Wales Hospital | Shatin | |
| Hong Kong | Alice Ho Miu Ling Nethersole Hospital | Tai Po | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Chung-Ang University Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Seoul Saint Mary Hospital | Seoul | |
| Korea, Republic of | Yonsei University Severance Hospital | Seoul | |
| New Zealand | Auckland City Hospital | Grafton | |
| Singapore | Changi General Hospital | Singapore | |
| Singapore | National University Hospital | Singapore | |
| Singapore | Singapore General Hospital | Singapore | |
| Thailand | Ramathibodi Hospital | Bangkok | |
| Thailand | Siriraj Hospital | Bangkok | |
| Thailand | Thai Red Cross AIDS Research Centre (HIV-NAT) | Bangkok | |
| Thailand | Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital | Muang | |
| United Kingdom | King's College Hospital NHS Foundation Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences | Vir Biotechnology, Inc. |
Australia, Denmark, Hong Kong, Korea, Republic of, New Zealand, Singapore, Thailand, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of Participants Who Achieve Functional Cure | Functional cure is defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) DNA < lower limit of quantitation (LLOQ) | Up to Week 60 | |
| Secondary | Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss With and Without Anti-HBsAg Seroconversion | Up to 84 Weeks | ||
| Secondary | Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss With and Without Anti-HBeAg Seroconversion in Participants With CHB Who Are HBeAg-Positive at Baseline | Up to 84 Weeks | ||
| Secondary | Proportion of Participants Who Remain Off Nucleos(t)ide(s) (NUC) Treatment During Follow-Up | Week 36 up to Week 84 | ||
| Secondary | Proportion of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough | Virologic breakthrough is defined as confirmed HBV DNA = LLOQ after 2 consecutive HBV DNA < LLOQ in participants who are complying with NUC therapy or confirmed HBV DNA = 1 log10 IU/mL increase from nadir. | Up to 36 Weeks |
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