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This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of RicovirĀ® in maintaining durability of viral response in CHB patients who have been treated with VireadĀ® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RicovirĀ® group | Experimental |
| |
| Historical Control Group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir disoproxil fumarate | Drug | RicovirĀ® (tenofovir disoproxil fumarate 300 mg) 1 tablet daily. The overall treatment period is 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the rates of virological recurrence of HBV | To assess the rates of virological recurrence of HBV at Week 24 with RicovirĀ® treatment. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the HBV DNA levels between RicovirĀ® group and historical control group | To compare the HBV DNA levels at Week 24 between RicovirĀ® group and historical control group. | Week 24 |
| Comparison of the rates of virological recurrence of HBV between RicovirĀ® group and historical control group. |
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RicovirĀ® Group
Inclusion Criteria:
Exclusion Criteria:
Historical Control Group
Eligible individuals will be obtained from the TCVGH historical database based on matching (1:1) in terms of age (±5 years) and gender. To be eligible for the study, subjects must meet all of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Hadigal, Dr. | Mylan Pharmaceuticals Private Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
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| Historical Data | Other | Historical Data |
|
To compare the rates of virological recurrence of HBV at Week 24 between RicovirĀ® group and historical control group. |
| Week 24 |
| Monitoring of Safety profile for subjects in RicovirĀ® group | For subjects in RicovirĀ® group, physical examination, vital signs, HBV DNA level, and concomitant medications will be evaluated at Week 4, 12 and 24 after treatment. Hematology and clinical biochemistry will be performed every 12 weeks. Adverse events (AEs) will be monitored continuously during the study. | Up to 24 weeks |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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