The Optimizing Treatment of Peginterferon (PEG IFN) Alpha in Chronic Hepatitis B Virus Patients With Low Level HBsAg
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|ClinicalTrials.gov Identifier: NCT02893124|
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : May 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: peginterferon alfa||Phase 4|
It is estimated that more than 400 million people are infected with hepatitis B virus (HBV) globally. HBeAg-negative CHB patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled in the out-patient department of 3rd Affiliated Hospital of Sun Yat-sen University. All of them were HBsAg positive and anti-HBs negative for more than 6 months with HBV DNA<100 IU/mL and HBsAg levels <1000 IU/mL. All patients did not have other liver diseases and contraindications for interferon therapy.
After giving informed consent, patients were treated with NAs once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study.
In this study, treatment endpoint was HBsAg loss(＜0.05 IU/mL).Anti-HBs positive(＞10 milli-International unit)(mIU/mL) defined as seroconversion. Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in case of nonresponse.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Optimizing Treatment of Peginterferon Alpha in HBeAg-negative Chronic Hepatitis B Virus Patients With Low Level HBsAg|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: PEG-IFN group
HBeAg-negative CHB patients with HBsAg <1000 IU/ mL and HBV DNA<100 IU/mL are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for at most 96 weeks.
Drug: peginterferon alfa
peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.
Other Name: peginterferon alfa-2a or peginterferon alfa-2b
No Intervention: NAs group
CHB patients do not need to change their NAs treatment.
- HBsAg Clearance [ Time Frame: 96 weeks ]Percentage of Participants with HBsAg <0.05 IU/mL.
- HBsAg Seroconversion [ Time Frame: 96 weeks ]Percentage of Participants with HBsAg <0.05 IU/mL and anti-HBsAg positive.
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): NCT02893124
|Contact: Xiang Zhufirstname.lastname@example.org|
|Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510630|
|Contact: Zhi-Liang Gao, Professor 86-20-85252373 email@example.com|
|Contact: Xiang Zhu, Doctor 86-20-85252372 firstname.lastname@example.org|
|Principal Investigator: Zhi-Liang Gao, Professor|