Phase 1b study in special populations of patients with Hepatitis B
Research type
Research Study
Full title
A Phase 1b, Open-label, Multi-center Study to Evaluate the Safety, Tolerability and Activity of GS-9688 in Special Populations of Subjects with Chronic Hepatitis B
IRAS ID
267013
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Gilead Sciences, Inc
Eudract number
2019-001474-28
Duration of Study in the UK
2 years, 8 months, 3 days
Research summary
Study Summary:
This study is investigating the medication known as GS-9688 in participants with Chronic Hepatitis B (CHB) virus. GS-9688 is an oral immune booster. The purpose of this study is to see if the study medication is safe, tolerable, and effective in special populations of CHB patients.This study will involve approximately 45 participants (male and female aged 18-65 years of age) at 2 sites globally. In the UK, this study will be conducted at one NHS Hospital. Participants eligible to take part in this study in the UK may be assigned to only the 3rd of 3 groups, known as cohorts.
Participants may be in the study for up to 48 weeks (not including screening). During this time participants will have to visit the site at least 15 times.
During participation in the study, participants will undergo some of the following procedures and tests: physical exams, assessment of vital signs, blood sample tests, urine tests, ECG test and stool sample tests etc.
Participants will also have the option to take part in a Fine Needle Aspiration (FNA), Intensive Pharmacokinetic, Genomic, Future Research and a Leukapheresis (separating white blood cells from the blood) sub-studies. Participants can take part in the main study even if they do not wish to take part in these optional sub-studies.
Summary of Results:
The purpose of this study was to learn how safe, tolerable, and effective selgantolimod was in treating people living with chronic hepatitis B (CHB), who had a specific set of criteria. Selgantolimod is an investigational drug, also known as GS 9688.
What are Chronic Hepatitis B and Hepatitis D?
Hepatitis B and Hepatitis D are infections of the liver.
Hepatitis B is caused by the Hepatitis B virus (HBV). In some people, hepatitis B persists for a long time, at least 6 months or longer, and is called CHB. CHB can put people at a high risk of death from cirrhosis (severe scarring of the liver) and liver cancer.
Hepatitis D is caused by a virus called Hepatitis D virus (HDV). HDV unlike HBV is not capable of causing an infection on its own. It causes infection only in the presence of HBV. Together, they cause very bad effects on the liver.
Common tests for checking CHB are:
• Blood test: It looks for specific proteins of the virus in blood like hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg). In this study, the researchers did a quantitative HBsAg (qHBsAg) test to find the amount of HBsAg in participant’s blood
• Viral load test: It is based on the presence of virus DNA or RNA in blood. This test was done in this study to find HBV DNA and HDV RNA in the participant’s blood.
DNA, deoxyribonucleic, and RNA, ribonucleic acid, are the essential building blocks in all living organisms. Virus’ DNA and RNA play a role in its growth and replication in the infected liver cells.
There were 3 Groups in this study. All groups received selgantolimod treatment in parallel.
Each group had a specific set of criteria, listed below:
• Group 1: Included HBeAg-positive participants who were not taking any oral antiviral (OAV) therapy for CHB, had high HBV DNA levels, and normal levels of a liver enzyme called alanine aminotransferase (ALT).
• Group 2: Included HBeAg-negative participants who were not taking OAV for CHB, had low viral HBV DNA levels, and normal ALT levels.
• Group 3: Included participants who had HDV infection along with HBV infection and were taking OAV for CHB.
The main questions the researchers wanted to answer in this study were:
• How many participants had the desired level of decrease in qHBsAg levels in their blood at Week 24?
• How many participants in Groups 1 and 2 had very low HBV DNA levels in their blood, which did not show up in the test at Week 24?
• How many participants in Group 3 had the desired level of decrease in HDV RNA levels in their blood at Week 24?
• What unwanted medical events did participants have during the study, if any?
What happened during the study?
The study started in November 2019 and ended in November 2022. A total of 25 participants took part in the study in Taiwan and the United Kingdom.
Group 1 had 5 participants, Group 2 had 14 participants, and Group 3 had 6 participants. All participants completed the study as planned.
This was an open-label study, where the participant, the study doctor/study staff knew that all participants took selgantolimod.
All participants received selgantolimod 3 mg as 2 tablets of 1.5 mg, every week for up to 24 weeks. All participants took the study drug in a fasting state. Group 3 participants continued to take OAV therapy during the study along with the study treatment. After 24 weeks of study treatment, participants continued in the study for up to 48 weeks.
What were the results of the study?
This is a summary of the main results from this study. The researchers wanted to find out:
a) the percentage of participants with desired levels of decrease in qHBsAg in their blood at Week 24,
b) the percentage of participants in Groups 1 and 2 with very low HBV DNA levels, in their blood, which do not show up in measurement at Week 24, and
c) the percentage of participants in Group 3 with the desired level of decrease in HDV RNA levels in their blood at Week 24.
None of the participants in any of the groups achieved the desired levels of qHBsAg, HBV DNA, or HDV RNA in their blood at Week 24.
What did researchers find about the safety of selgantolimod?
The researchers kept track of any unwanted medical events that the participants had during the study. They may or may not have been related to the study treatment. An unwanted medical event is considered “serious” if it:
• leads to death,
• is life-threatening,
• considered by the study doctor to be medically important, • causes lasting problems, • requires inpatient hospital care Overall, all participants had some medical events during the study. Most events related to study drugs were non-serious. One participant in Group 3 had a serious medical event of vomiting. This event improved with treatment, and they continued the study. None of the participants died during the study.
This summary was created and approved by Gilead Sciences in September 2023. The information in this summary does not include any information available after this date.
Thank you
Thank you to the participants who took part in this clinical study on selgantolimod.REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1302
Date of REC Opinion
21 Oct 2019
REC opinion
Further Information Favourable Opinion