In short
Clinical trials are investigating Selgantolimod in people with chronic hepatitis B. These studies look at whether it can help improve key virus markers and support treatment plans that include stopping nucleos(t)ide analogue therapy after a study period.
Key points
- Selgantolimod is being studied in a Phase 2 clinical trial for chronic hepatitis B. The trial focuses on HBeAg-negative patients and compares a treatment plan that includes Selgantolimod with standard hepatitis B therapy. Researchers are looking at whether the study approach can reduce HBsAg, a key virus marker, by week 76. The trial also compares stopping nucleos(t)ide analogue treatment with continuing it for 76 weeks. This is an interventional study with 51 planned participants.
Clinical trial overview
The trial listed for Selgantolimod is ANRS HB07 IP-Cure-B, a proof of concept study in chronic hepatitis B. A proof of concept trial is an early study that asks whether a treatment approach may work in people.
This study is interventional, which means the researchers give study treatments and compare the results between groups. The study status is authorised.
Who the study is for
The trial targets people with HBV, which is short for hepatitis B virus infection. The brief summary says the control arm is the standard of care for HBeAg-negative patients with chronic hepatitis B.
HBeAg-negative means a certain hepatitis B blood marker is not present, and this detail matters because treatment plans can differ by patient group.
What the study is testing
The trial is studying the virological effect of stopping nucleos(t)ide analogue treatment, with or without Selgantolimod first. Nucleos(t)ide analogues are common hepatitis B medicines used to keep the virus under control.
According to the study summary, one key question is whether stopping NUC after Selgantolimod treatment can improve outcomes compared with continuing NUC treatment alone for 76 weeks.
The interventions listed in the trial include Selgantolimod and standard hepatitis B medicines such as Vemlidy, Baraclude, and Viread.
Study phase and size
This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may work while continuing to monitor safety and study design questions.
The planned enrollment is 51 participants. That means the study is relatively small and designed to give early answers about the treatment strategy.
Main endpoint and what it means
The primary endpoint is the percentage of participants with a ≥ 1.0 log10 IU/mL decline in HBsAg at week 76 compared with baseline. Baseline means the starting point before treatment effects are measured.
A drop of 1.0 log10 IU/mL means the HBsAg level falls by a tenfold amount, which is a large change in the virus marker. This endpoint helps researchers judge whether the study treatment plan has a meaningful effect on hepatitis B markers.
Treatment comparison in the trial
The study compares three ideas: continuing NUC treatment for 76 weeks, stopping NUC after Selgantolimod treatment, and stopping NUC without that same study approach. The control arm is continuous NUC treatment, which the summary describes as standard of care for HBeAg-negative chronic hepatitis B patients.
This design helps researchers see whether Selgantolimod changes the chance of lowering HBsAg after treatment is stopped.
Important patient terms
- HBV: hepatitis B virus, the virus that causes hepatitis B infection.
- HBsAg: a blood marker used to track hepatitis B activity.
- NUC: nucleos(t)ide analogue, a type of hepatitis B treatment.
- Virological efficacy: how well a treatment affects the virus or virus markers.
- Proof of concept: an early study to see if an approach may work.