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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02838810
Other study ID # I-Cure-2
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 2016
Est. completion date December 2019

Study information

Verified date January 2019
Source Third Affiliated Hospital, Sun Yat-Sen University
Contact Xiang Zhu, Doctor
Phone 13826452564
Email 0628zhuxiang@163.com
Is FDA regulated No
Health authority
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. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2019
Est. primary completion date December 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.

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 AFP >2 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 or have NAs drug resistance.

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

Study Design


Intervention

Drug:
peginterferon alfa
peginterferon alfa-2b or peginterferon alfa-2a
Nucleoside analogues
Nucleoside analogues

Locations

Country Name City State
China The third affiliated hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (4)

Lead Sponsor Collaborator
Third Affiliated Hospital, Sun Yat-Sen University First People's Hospital of Foshan, Peking University, Shenzhen Third 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. 120 weeks
Primary HBsAg Seroconversion Percentage of Participants with HBsAg <0.05 IU/mL and anti-HBsAg positive. 120 weeks
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