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Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT03905655
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.

Brief 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).

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Placebo Oral Tablet Drug: Nitazoxanide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized 1:1:1:1 (12 subjects per group)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group 1
Three placebo tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Drug: Placebo Oral Tablet
Number of placebo tablets administered orally depends on the arm

Active Comparator: Group 2
Two 300 mg NTZ tablets and one placebo tablet administered orally in the morning and three placebo tablets in the evening in addition to continuing TDF, TAF or ETV therapy
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
Other Name: NTZ, NT-300

Active Comparator: Group 3
Two 300 mg NTZ tablets and one placebo tablet administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
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
Other Name: NTZ, NT-300

Active Comparator: Group 4
Three 300 mg NTZ tablets administered orally twice daily with food in addition to continuing TDF, TAF or ETV therapy
Drug: Nitazoxanide
Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
Other Name: NTZ, NT-300




Primary Outcome Measures :
  1. Mean change in quantitative Hepatitis B Surface Antigen (qHBsAg) [ Time Frame: Baseline to 12 weeks ]
    Mean change in qHBsAg



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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at least 21 years
  2. CHB virus infection (serum HBsAg-positive for at least 6 months or serum HBsAg-positive and negative immunoglobulin M (IgM) antibodies to Hepatitis B Virus (HBV) core antigen (IgM anti-HBc))
  3. Hepatitis B e Antigen (HBeAg) negative
  4. Virologically suppressed (HBV DNA less than the lower limit of quantitation) for at least 12 months on Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF) or Entecavir (ETV) therapy
  5. Quantitative HBsAg greater than 100 IU/mL
  6. Alanine Aminotransferase (ALT) below 1.5 times the upper limit of normal
  7. Able to comply with the study requirements

Exclusion Criteria:

  1. Unable to take oral medications
  2. Females who are pregnant, breast-feeding or not using birth control. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an intrauterine device (IUD), or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. In addition, female subjects should have a baseline pregnancy test and should agree to continue an acceptable method of birth control for the duration of the study (including follow-up) if sexually active.
  3. Any investigational drug therapy within 30 days prior to enrollment
  4. Other causes of liver disease
  5. Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV) based on an enzyme immunoassay (EIA)
  6. History of alcoholism or with an alcohol consumption of greater than 40 g per day
  7. Clinically unstable
  8. Any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed
  9. History of hypersensitivity or intolerance to NTZ or any of the excipients comprising the NTZ tablets
  10. Hepatocellular carcinoma
  11. Decompensated liver disease including history of ascites, bleeding esophageal varices, portal hypertension or hepatic encephalopathy
  12. FibroScan® score greater than 11 or history of cirrhosis on liver biopsy
  13. Creatinine clearance <65 ml/minute (by the Cockcroft-Gault equation using ideal body weight)
  14. History of clinically relevant psychiatric disease, seizures, central nervous system dysfunction, severe pre-existing cardiac, renal, pathologic bone fracture or other risk factors for osteoporosis, hematological disease or medical illness that in the investigator's opinion might interfere with therapy
  15. Malignant disease within 3 years of trial entry
  16. Rheumatological conditions, inflammatory bowel disease or psoriasis requiring or anticipated to require biological/immunosuppressive therapies
  17. Subjects taking or anticipated to need medications considered to be major CYP2C8 substrates

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905655


Contacts
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Contact: Celine Rossignol 813-282-8544 celine.rossignol@romark.com

Locations
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Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Seng Gee Lim    +65 6772 4447      
Sponsors and Collaborators
Romark Laboratories L.C.

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Responsible Party: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT03905655     History of Changes
Other Study ID Numbers: RM08-2001
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Hepatitis, Viral, Human
Nitazoxanide
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiparasitic Agents
Anti-Infective Agents