The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

Chronic Hepatitis B Clinical Trial

Official title:

The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02745704
• Other study ID #: 3rd-SYSU-I-Cure
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: January 2019
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.

Description:

In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 24 weeks.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

1. CHB patients who had received NAs for more than 12 months.

2. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.

3. Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL.

4. Hepatitis B virus DNA not detectable(Roche Cobas).

Exclusion Criteria:

1. Patients with liver cirrhosis, Hepatocellular Carcinoma 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 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-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week

Locations

Country	Name	City	State
China	The third affiliated 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 negative.	72 weeks
Primary	HBsAg Seroconversion	Percentage of Participants with HBsAg negative and anti-HBsAg positive.	72 weeks