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Canocapavir (ZM-H1505R) + NAs in Chronic Hepatitis B
NCT07095855Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Aug 2025
- Primary completion
- Jan 2028
- Countries
- 1
- Sponsor
- Zhimeng Biopharma
- Modality
- Small Molecules
- Drugs
- Canocapavir
- Conditions
- Chronic Hepatitis B (CHB)
01
Overview
Phase 3, randomised, double-blind trial in Chronic Hepatitis B (CHB) comparing ZM-H1505R + NAs with Placebo + NAs (2 arms). Primary endpoint: Complete Virologic Response at 48 weeks. Planned start Aug 2025; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
ZM-H1505R + NAs
Canocapavir 100mg QD + NAs
Placebo + NAs
Placebo + NAs (switching to Canocapavir in Part B)
03
Who it enrols
Adults 18-65 with Chronic Hepatitis B, HBeAg positive, HBV DNA >= 50 IU/mL, on stable NAs (ETV, TDF, TAF, or TMF) for at least 12 months. Exclusion includes cirrhosis (Metavir >= 3, Ishak >= 4, FibroScan >= 9 kPa), HCC, coinfection with HIV/HCV/HDV/HEV, or significant lab abnormalities.
04
Endpoints
Primary
Complete Virologic Response
Secondary
Safety and Tolerability
Complete Virologic Response Rate over time
Time to achieve Complete Virologic Response
HBV DNA <= 20 IU/mL
Change in quantitative HBV RNA
Achievement of LLOQ of HBV RNA
Change in quantitative serum HBsAg
Change in HBeAg
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