At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 31 enrolled
Drug / intervention
IONIS-HBVRx +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Escalation Study to Examine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ISIS 505358 in Treatment-Naïve Patients With Chronic HBV Infection
In Brief
A Phase 2 clinical trial evaluating IONIS-HBVRx and Placebo for Hepatitis B and Chronic Hepatitis B Atypical. Completed, enrolled 31 participants across 7 sites in 2 countries.
Detailed Summary
To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic Hepatitis B Atypical
CountriesHong Kong, South Korea
CollaboratorsIonis Pharmaceuticals, Inc.
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartFeb 2017
Primary CompletionDec 2019
Study CompletionDec 2019
TodayJul 2026
First PostedDec 5, 2016
Enrollment StartFeb 24, 2017
Primary CompletionDec 18, 2019
Study CompletionDec 26, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.6 years ago
Interventions
IONIS-HBVRxdrug
Ascending multiple doses of IONIS-HBVRx by subcutaneous (SC) injection
Placebodrug
Placebo