At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 51 enrolled
Drug / intervention
Placebo Oral Tablet +1 moredrug
Likely dose
Nitazoxanide 300 mgfrom 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.
Randomized Double-Blind Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B Virologically Suppressed for at Least Twelve Months on Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide or Entecavir
In Brief
A Phase 2 clinical trial evaluating Placebo Oral Tablet and Nitazoxanide for Chronic Hepatitis B. Completed, enrolled 51 participants across 1 site.
Detailed Summary
This randomized controlled trial is designed to evaluate safety, effectiveness and pharmacokinetic-pharmacodynamic (PK/PD) relationships associated with three different Nitazoxanide (NTZ) treatment regimens added to Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF) or Entecavir (ETV) in treating Chronic Hepatitis B (CHB).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesSingapore
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartOct 2019
Primary CompletionMar 2021
Study CompletionOct 2021
TodayJul 2026
First PostedApr 5, 2019
Enrollment StartOct 22, 2019
Primary CompletionMar 10, 2021
Study CompletionOct 11, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.2 years ago
Interventions
Placebo Oral Tabletdrug
Number of placebo tablets administered orally depends on the arm
Nitazoxanidedrug
Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm