Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection

Chronic Hepatitis b Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02973646
• Other study ID #: PL2
• Status: Recruiting
• Phase: Phase 4
• First received: November 13, 2016
• Last updated: November 23, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Wenxiong Xu, Master
• Phone: +8613760783281
• Email: xwx1983[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial Summary

The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic hepatitis b patients with e antigen positive based on the detection of interferon gene mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.

Description:

Patients with e antigen positive chronic hepatitis b were enrolled in the study. Age, sex, symptoms (e.g., fever, fatigue, poor appetite, jaundice) were recorded in the study. We also observed the laboratory test results including the levels of white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), platelet (PLT), alanine transaminase (ALT), aspartate transaminase (AST), hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), and hepatitis B virus (HBV) DNA; detection of gene mutation (IFNA2 p.Ala120Thr), levels of interferon receptor (IFNAR2).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Chronic hepatitis b Patients who should receive anti-HBV therapy according to guideline and are willing to receive interferon therapy;

2. Hepatitis B e antigen positive.

Exclusion Criteria:

1. Patients received anti-HBV therapy in the past 6 months;

2. Patients with liver cirrhosis or hepatocellular carcinoma or other malignancies;

3. Patients with other factors causing active liver diseases;

4. Pregnancy or lactation women;

5. Patients with HIV infection or congenital immune deficiency diseases;

6. Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.

7. Patients with other reasons not suitable to receive interferon therapy.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• Peginterferon Alfa-2B

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	good virologic response	level of HBsAg is less than or equal to 1500 IU/ml	24th week	No
Secondary	common virologic response	level of HBsAg is more than 1500 IU/ml, also less than or equal to 20000 IU/ml	24th week	No
Secondary	bad virologic response	level of HBsAg is more than 20000 IU/ml, level of HBV DNA is equal to or more than 4.0 log10 IU/ml	24th week	No