Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection
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|ClinicalTrials.gov Identifier: NCT02973646|
Recruitment Status : Unknown
Verified November 2016 by Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Recruiting
First Posted : November 25, 2016
Last Update Posted : November 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis b||Drug: Entecavir or Tenofovir Drug: Peginterferon Alfa-2B||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation on Antiviral Therapy of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B Patients Based on Detection of Interferon Gene Mutation and Interferon Receptor|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Nucleos(t)ide analogues treatment
Patients with interferon receptor level down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 24th week, then nucleos(t)ide analogues (entecavir tablet 0.5mg/d or tenofovir tablet 300mg/d) from 25th to 36th week, then peginterferon alfa-2b injection 80ug/d again from 36th to 48th week.
Drug: Entecavir or Tenofovir
Patients in nucleos(t)ide analogues treatment for 12 weeks group will receive nucleos(t)ide analogs therapy (Entecavir tablet 0.5mg/d or Tenofovir tablet 300mg/d) from Week 25th to 36th.
Drug: Peginterferon Alfa-2B
Active Comparator: Peginterferon treatment
Patients with interferon receptor level not down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 48th week.
Drug: Peginterferon Alfa-2B
- good virologic response [ Time Frame: 24th week ]level of HBsAg is less than or equal to 1500 IU/ml
- common virologic response [ Time Frame: 24th week ]level of HBsAg is more than 1500 IU/ml, also less than or equal to 20000 IU/ml
- bad virologic response [ Time Frame: 24th week ]level of HBsAg is more than 20000 IU/ml, level of HBV DNA is equal to or more than 4.0 log10 IU/ml
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): NCT02973646
|Contact: Wenxiong Xu, Masterfirstname.lastname@example.org|
|Contact: Liang Peng, Doctoremail@example.com|
|The Third Affiliated Hospital of Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510630|
|Contact: Liang Peng, Doctor +8613533978874 firstname.lastname@example.org|
|Principal Investigator:||Liang Peng, Doctor||Third Affiliated Hospital, Sun Yat-Sen University|