Adults 21 to 100, any sex, with Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change in Quantitative Hepatitis B Surface Antigen (qHBsAg)Primary· Baseline to 12 weeks
Mean change in quantitative Hepatitis B Surface Antigen (qHBsAg) from Baseline
Group
Value
95% CI
Group 1
0.0
± 0.13
Group 2
0.0
± 0.90
Group 3
0.0
± 0.06
Group 4
0.0
± 0.10
Sustained HBsAg Loss With Suppression of HBV DNA for 24 Weeks After the End of TreatmentSecondary· Baseline to 24 weeks after the end of treatment
Proportion of participants with sustained HBsAg loss with suppression of HBV DNA for 24 weeks after the end of treatment
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Change in Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline to Different Time Points on TreatmentSecondary· 8 weeks
Change in mean Quantitative Hepatitis B Surface Antigen (qHBsAg) from Baseline to Day 3, Week 1, Week 2, Week 4, and Week 8
Day 3
Group
Value
95% CI
Group 1
0.0
± 0.04
Group 2
0.0
± 0.08
Group 3
0.0
± 0.04
Group 4
0.0
± 0.06
Week 1
Group
Value
95% CI
Group 1
0.0
± 0.06
Group 2
0.0
± 0.05
Group 3
0.0
± 0.04
Group 4
0.0
± 0.05
Week 2
Group
Value
95% CI
Group 1
0.0
± 0.05
Group 2
0.0
± 0.11
Group 3
0.0
± 0.04
Group 4
0.1
± 0.05
Week 4
Group
Value
95% CI
Group 1
0.0
± 0.08
Group 2
0.0
± 0.09
Group 3
0.0
± 0.05
Group 4
0.1
± 0.07
Week 8
Group
Value
95% CI
Group 1
0.0
± 0.06
Group 2
0.0
± 0.14
Group 3
-0.1
± 0.07
Group 4
0.0
± 0.10
Hepatitis B Surface Antigen (HBsAg) LossSecondary· 12 weeks
Proportion of participants with HBsAg loss defined as quantitative HBsAg below the lower limit of quantitation at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12
Day 3
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Week 1
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Week 2
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Week 4
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Week 8
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Week 12
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Hepatitis B Surface Antigen (HBsAg) SeroconversionSecondary· 12 weeks
Proportion of participants with hepatitis B surface antigen (HBsAg) seroconversion defined as HBsAg loss and gain of anti-hepatitis B antibodies at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12
Day 3
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Week 1
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Week 2
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Week 4
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Week 8
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Week 12
Group
Value
95% CI
Group 1
0
Group 2
0
Group 3
0
Group 4
0
Hepatitis B Virus DNA SuppressionSecondary· 12 weeks
Proportion of participants with hepatitis B virus DNA suppression defined as hepatitis B virus DNA below the lower limit of quantitation (20 IU/mL) at Day 3, Week 1, Week 2, Week 4, Week 8, and Week 12
Day 3
Group
Value
95% CI
Group 1
13
Group 2
13
Group 3
11
Group 4
13
Week 1
Group
Value
95% CI
Group 1
13
Group 2
12
Group 3
11
Group 4
14
Week 2
Group
Value
95% CI
Group 1
13
Group 2
12
Group 3
11
Group 4
13
Week 4
Group
Value
95% CI
Group 1
13
Group 2
12
Group 3
11
Group 4
13
Week 8
Group
Value
95% CI
Group 1
13
Group 2
12
Group 3
11
Group 4
14
Week 12
Group
Value
95% CI
Group 1
13
Group 2
13
Group 3
11
Group 4
13
Change in Fibrosis-4 (FIB-4) ScoreSecondary· 12 weeks
Mean change in Fibrosis-4 (FIB-4) score from Baseline to Week 1, Week 2, Week 4, Week 8, and Week 12. FIB-4 score is calculated as (age in years \* Aspartate aminotransferase (AST) in U/L)/(platelet count in 10\^9 U/L \* square root of alanine aminotransferase (ALT) in U/L). FIB-4 scores under 1.45 have a negative predictive value of 90% for advanced fibrosis (better outcome) and FIB-4 scores \>3.25 have a positive predictive value of 65% for advanced fibrosis (worse outcome). See Sterling RK, Lissen E, Clumeck N, et. al. Development of a simple noninvasive index to predict significant fibrosi
Week 1
Group
Value
95% CI
Group 1
-1.7
± 0.88
Group 2
-2.8
± 0.97
Group 3
-2.9
± 2.68
Group 4
-2.0
± 0.86
Week 2
Group
Value
95% CI
Group 1
-1.4
± 1.08
Group 2
-2.8
± 1.06
Group 3
-2.9
± 2.61
Group 4
-1.8
± 0.88
Week 4
Group
Value
95% CI
Group 1
-1.7
± 0.88
Group 2
-2.9
± 1.03
Group 3
-2.9
± 2.81
Group 4
-1.8
± 1.07
Week 8
Group
Value
95% CI
Group 1
-1.7
± 1.00
Group 2
-2.9
± 1.05
Group 3
-2.8
± 2.67
Group 4
-2.1
± 0.91
Week 12
Group
Value
95% CI
Group 1
0.0
± 0.57
Group 2
-1.2
± 1.06
Group 3
-1.0
± 1.51
Group 4
-0.8
± 0.76
Change in FibroScan ScoreSecondary· Baseline to end of treatment
Mean change in FibroScan score from Baseline to end of treatment. Fibroscan is a kind of liver elastography measuring liver stiffness in kilopascals (kPa). Higher results are consistent with liver disease (worse outcome).
Group
Value
95% CI
Group 1
0.0
± 1.41
Group 2
2.0
± 1.73
Group 3
0.0
± 0.82
Group 4
1.3
± 1.53
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 60 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Group 1
Serious: 1/13 (8%)
Deaths: 0/13
Group 2
Serious: 0/13 (0%)
Deaths: 0/13
Group 3
Serious: 0/11 (0%)
Deaths: 0/11
Group 4
Serious: 1/14 (7%)
Deaths: 1/14
Serious adverse events (2 terms)
Reaction
System
Group 1
Group 2
Group 3
Group 4
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
· Phase 1
· recruiting
NCT07135349 — A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B
· Phase 2
· active not recruiting
NCT07307586 — A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatiti
· Phase 3
· recruiting
NCT07246889 — Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)
· Phase 3
· active not recruiting
Other Romark Laboratories L.C. trials
Trials by the same sponsor.
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· terminated
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· Phase 3
· completed
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· Phase 3
· completed
NCT04343248 — Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Vira
· Phase 3
· terminated
NCT03605862 — Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Romark Laboratories L.C.
Last refreshed: 7 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03905655.