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The CHB subjects who are cirrhosis, will be randomized to two groups.
The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks.
The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.
This study is a prospective, randomized, open-label study.
The CHB subjects who are cirrhosis will be randomized to two groups.
The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks.
The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination | Experimental | The subjects will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a |
|
| nucleotide analogue | Active Comparator | The subjects will be treated by nucleotide analogue (NA) only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon Alfa-2A | Drug | 180μg/week, 48 weeks; 135μg/week,48weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who develop to hepatocellular carcinoma during 5 years | The number of subjects develop to hepatocellular carcinoma during 5 years will be measured | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who achieve HBeAg loss and HBeAg seroconversion | The number of subjects with HBeAg loss and HBeAg seroconversion at year 1 ,2,3,4 and 5 will be measured | year 1,2,3,4,5 |
| Number of participants who achieve HBsAg loss and HBsAg seroconversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chenbo Hu | Nanhua Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanhua Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| C053001 | adefovir |
| C413685 | entecavir |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Adefovir, entecavir,tenofovir, either of them | Drug | Adefovir, entecavir,tenofovir, either of them is ok |
|
The number of subjects with HBsAg loss and HBsAg seroconversion at year 1, 2,3,4 and 5 will be measured |
| year 1,2,3,4,5 |
| The factor such as HBsAg level related to the incidence of HCC development | The HBsAg level at year 1 will be measured, to assess whether the quantitative HBsAg level related to the incidence of HCC development | year 1 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |