HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

Chronic Hepatitis B (HBeAg-negative) Clinical Trial

Official title:

HBsAg Loss Adding Pegylated Interferon Alfa-2a in HBeAg-negative Patients Treated With Nucleos(t)Ide Analogues.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743182
• Other study ID #: QUANTI-B
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: November 2018

Study information

• Verified date: September 2019
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen "s" (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic hepatitis B (HBeAg-negative)

• Signed inform consent

• Aged > 18

Exclusion Criteria:

• Contraindications for Pegylated interferon (cirrhosis, pregnancy, others)

• Previous treatment with interferon or Pegylated interferon

• Previous HBsAg loss

• Treatment duration with Nucleos(t)ide analogues less than 2 years

• Poor adherence to Nucleos(t)ide analogues

Related Conditions & MeSH terms

• Chronic Hepatitis B (HBeAg-negative)
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Pegylated interferon alfa-2a

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
José Antonio Carrion	Instituto de Salud Carlos III

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with HBsAg loss	HBsAg will be evaluated one year after treatment completion (96 weeks). Efficacy will be calculated as a proportion (rate of patients with HBsAg loss/treated patients)	1 year after treatment completion