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This is a phase three study to evaluate the safety and efficacy of Pradefovir treatment in chronic hepatitis B patients. Subject will be randomized to Pradefovir group and TDF group at a ratio of 2:1. Treatment duration will be 96w in randomization and followed by 48w in open. The interim analysis will be conducted when all subject completed the first 48-week treatment.
this is a randomized, double-blind, positive drug parallel control, multicenter, phase 3 study .Eligible HBeAg-positive or HBeAg-negative chronic hepatitis B patients will be stratified by historical antiviral treatment (untreated or treated) at the time of screening, and then randomly assigned to Pradefovir mesylate tablet group or tenofovir disoproxil fumarate tablet group at a ratio of 2:1. The proportion of subject with compensatory stage of cirrhosis is no more than 20 percentage. Patients will receive a total of 144 weeks of antiviral treatments, and after 96 weeks of double-blind treatment, all subjects will switch to open mesylate Pradefovir tablets for additional 48 weeks. The first 48 weeks are the core period and the followed 96 weeks are the extension period. Statistical analysis was conducted on the efficacy and safety of the whole trial. (After the completion of 48-week visit of the last one subject, the interim analysis will be conducted. The analysts will be unblinded, while the remaining participants will still be blind.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial group | Experimental | subject in this group will receive Pradefovir mesylate tablet and the placebo of tenofovir disoproxil fumarate tablet, once daily for 96 weeks |
|
| Control group | Active Comparator | subject in this group will receive tenofovir disoproxil fumarate tablet and the placebo of Pradefovir mesylate tablet, once daily for 96 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tablet | Drug | Once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HBV viral suppression | proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<29IU/ml) | After 48-week therapy |
| Measure | Description | Time Frame |
|---|---|---|
| HBV viral suppression | proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<29IU/ml) | After therapy of 4, 8, 12, 24, 36, 72, 96, 144 weeks |
| HBV viral suppression | proportion of patients with hepatitis B virus(HBV) -DNA undetectable(<20IU/ml) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| daidi Wang | Contact | +86 029 68790358 | wangdd@xtyw.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junqi Niu, Dr. | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130061 | China |
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| Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir Mesylate |
| Drug |
Once daily |
|
| After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks |
| The reduction of HBV DNA load | the change of HBV DNA load from baseline | at week 4, 8, 12, 24, 36, 48, 72, 96, 144 |
| ALT normalization | proportion of patients with ALT normalization | After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 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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