Trials / Completed
CompletedNCT03905655
Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Romark Laboratories L.C. · Industry
- Sex
- All
- Age
- 21 Years – 100 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo Oral Tablet | Number of placebo tablets administered orally depends on the arm |
| DRUG | Nitazoxanide | Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm |
Timeline
- Start date
- 2019-10-22
- Primary completion
- 2021-03-10
- Completion
- 2021-10-11
- First posted
- 2019-04-05
- Last updated
- 2023-11-07
- Results posted
- 2023-11-07
Locations
1 site across 1 country: Singapore
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03905655. Inclusion in this directory is not an endorsement.