The Optimizing Treatment of Peginterferon (PEG IFN) Alpha in Chronic Hepatitis B Virus Patients With Low Level HBsAg

Chronic Hepatitis B Clinical Trial

Official title:

The Optimizing Treatment of Peginterferon Alpha in HBeAg-negative Chronic Hepatitis B Virus Patients With Low Level HBsAg

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02893124
• Other study ID #: I-Cure-3
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: August 2019

Study information

• Verified date: May 2018
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Xiang Zhu
• Phone: 13826452564
• Email: 0628zhuxiang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (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. Treatment endpoint was HBsAg loss(＜0.05 IU/mL).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. CHB patients who had received single NAs for more than 12 months and had a history of NAs drug resistance or suboptimal/partial virological response.

2. Hepatitis B e antigen (HBeAg)-negative.

3. Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL.

4. Hepatitis B virus DNA <100 IU/mL.

Exclusion Criteria:

1. Patients with liver cirrhosis, Hepatocellular Carcinoma or alpha feto protein (AFP) >2 upper limit of normal(ULN) or other malignancies.

2. Patients with other factors causing liver diseases.

3. Pregnant and lactating women.

4. Patients with concomitant HIV infection or congenital immune deficiency diseases.

5. Patients with diabetes, autoimmune diseases.

6. Patients with important organ dysfunctions.

7. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)

8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.

9. Patients with a previous use of IFN anti hepatitis B virus treatment.

10. Patients who can't come back to clinic for follow-up on schedule.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• peginterferon alfa
peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.

Locations

Country	Name	City	State
China	Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (11)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University	First People's Hospital of Foshan, First People's Hospital, Shunde China, Huazhong University of Science and Technology, Huizhou Municipal Central Hospital, Nanchang University, Peking University, Shenzhen Third People's Hospital, Tang-Du Hospital, The First Affiliated Hospital of Kunming Medical College, Yuebei People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBsAg Clearance	Percentage of Participants with HBsAg <0.05 IU/mL.	96 weeks
Secondary	HBsAg Seroconversion	Percentage of Participants with HBsAg <0.05 IU/mL and anti-HBsAg positive.	96 weeks