Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss

Hepatitis B Clinical Trial

Official title:

The Efficacy of Peg-interferon α-2a in HBeAg (+) Chronic Hepatitis B Patients Who Have Been Treated by Entecavir for 48 Weeks But Without HBeAg Loss

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01599130
• Other study ID #: Zhangyufeng
• Status: Not yet recruiting
• Phase: N/A
• First received: May 8, 2012
• Last updated: May 14, 2012
• Start date: July 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2012
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Description:

For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 50 years old

• HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment

• Treated by entacavir for 48 weeks with HBeAg seroconversion

Exclusion Criteria:

• Pregnant women

• Decompensated liver disease

• Combination infection of HCV, HAV, or HEV

• Combination infection of HIV

• Any contraindication of interferon a

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Drug:
• Entecavir
entecavir 0.5mg per day
• Peginterferon alfa-2a
Peginterferon alfa-2a 180ug per week

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBeAg sericonversion rate		72 weeks	No
Secondary	HBeAg loss rate		72 weeks	No
Secondary	HBeAg quantification dynamic change		72 weeks	No
Secondary	HBsAg loss rate		72 weeks	No
Secondary	HBsAg seroconversion rate		72 weeks	No
Secondary	HBsAg quantification dynamic change		72 weeks	No
Secondary	ALT normalization rate		72 weeks	No