Trials / Terminated
TerminatedNCT03780543
A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Assembly Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 71 Years
- Healthy volunteers
- Not accepted
Summary
Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers.
Detailed description
This is an open-label extension of parent studies ABI-H0731-201 (NCT03576066) and ABI-H0731-202 (NCT03577171). The extension study will assess the safety of long-term (up to 100 weeks of treatment in extension study ABI-H0731-211) combination therapy and its effect on biomarkers of sustained viral response (SVR) (NCT03780543).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI) | Participants will continue on their SOC NrtI, Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir Alafenamide (TAF) tablet QD (once daily) orally as per approved package insert. |
Timeline
- Start date
- 2018-12-20
- Primary completion
- 2021-04-26
- Completion
- 2021-04-26
- First posted
- 2018-12-19
- Last updated
- 2023-04-19
- Results posted
- 2023-02-17
Locations
24 sites across 5 countries: United States, Canada, Hong Kong, New Zealand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03780543. Inclusion in this directory is not an endorsement.