Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The current study is a prospective, randomized, open, multi-center investigation. The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA<105copies/ml,HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.
The HBeAg positive chronic hepatitis B(CHB) subjects who has achieved HBV DNA<10*5copies/ml,HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2 will be randomized to three groups. The subjects who go into group A will be treated by tenofovir disoproxil fumarate (TDF) for 96 weeks; The subjects who go into group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks; The subjects who go into group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A,TDF | Active Comparator | The subjects in group A will be treated by TDF for 96 weeks |
|
| Group B,TDF+PEG | Experimental | The subjects in group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks |
|
| Group C,TDF+PEG | Experimental | The subjects in group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A, TDF | Drug | TDF for 96 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who achieve HBeAg seroconversion | The number of subjects with HBeAg seroconversion at week 96 will be measured | at 96 week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who achieve HBeAg seroconversion | The number of subjects with HBeAg seroconversion at week 48 and 72 will be measured | at 48 week;at 72 week |
| The percentage decrease of HBsAg level at group A,B,C |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinxin Zhang | Contact | zhangx@shsmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xinxin Zhang | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xixi Hospital of Hangzhou | Recruiting | Hangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26453773 | Result | Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon alpha-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8. | |
| 25190434 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Group B:TDF then TDF and Peginterferon alfa-2a | Drug | Subjects will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks |
|
|
| Group C:TDF and Peginterferon alfa-2a then TDF | Drug | Subjects will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks. |
|
|
The level of HBsAg in group A,B,C at week 48 ,72 and 96 will be measured,changing from baseline
| at 48 week;at 72 week;at 96 week |
| Number of participants who achieve HBeAg loss | The number of subjects with HBeAg loss at week48.72 and 96 will be measured | at 48 week;at 72 week;at 96 week |
| The number of subjects who achieve HBVDNA undetectable | The number of subjects with HBVDNA undetectable at week 24,48,72 and 96 will be measured | at 24 week;48 week;at 72 week;at 96 week |
| The factor such as HBsAg level related to responsible rate | The HBsAg level at week 48,72,96 will be measured, to assess whether the quantitative HBsAg level related to the responsible rate | at week 48,72,96 |
| The number of subjects who achieve ALT back to normal | The number of subjects with normal ALT at week 48,72 and 96 will be measured | at 48 week;at 72 week;at 96 week |
| Changhai Hospital | Recruiting | Shanghai | China |
|
| Hua shan Hospital,Fudan University | Recruiting | Shanghai | China |
|
| Infectious diesease hospital of Huangpu district in Shanghai | Recruiting | Shanghai | China |
|
| No.9 hospital of shanghai | Recruiting | Shanghai | China |
|
| Shanghai public health clinical center | Recruiting | Shanghai | China |
|
| Shuguang Hospital of Shanghai T.C.M | Recruiting | Shanghai | China |
|
| Tongren hospital Shanghai Jiaotong University School of medicine | Recruiting | Shanghai | China |
|
| Result |
| Xie Q, Zhou H, Bai X, Wu S, Chen JJ, Sheng J, Xie Y, Chen C, Chan HL, Zhao M. A randomized, open-label clinical study of combined pegylated interferon Alfa-2a (40KD) and entecavir treatment for hepatitis B "e" antigen-positive chronic hepatitis B. Clin Infect Dis. 2014 Dec 15;59(12):1714-23. doi: 10.1093/cid/ciu702. Epub 2014 Sep 4. |
| 25348661 | Result | Brouwer WP, Xie Q, Sonneveld MJ, Zhang N, Zhang Q, Tabak F, Streinu-Cercel A, Wang JY, Idilman R, Reesink HW, Diculescu M, Simon K, Voiculescu M, Akdogan M, Mazur W, Reijnders JG, Verhey E, Hansen BE, Janssen HL; ARES Study Group. Adding pegylated interferon to entecavir for hepatitis B e antigen-positive chronic hepatitis B: A multicenter randomized trial (ARES study). Hepatology. 2015 May;61(5):1512-22. doi: 10.1002/hep.27586. Epub 2015 Feb 27. |
| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| C100416 | peginterferon alfa-2a |
| 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 |
Not provided
Not provided