HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated

NCT01471535 | Completed DMC

• 1 other identifier: DTH-XY002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive carriers. The researchers aim to investigate the ability of peginterferon alpha-2a to achieve surface antigen loss/seroconversion therapy in inactive carriers with persistently normal alanine aminotransferase (ALT) levels, undetectable HBV DNA and low surface antigen levels, who would not generally be considered candidates for therapy.

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis B

Outcome Measures

Primary Outcomes (1)

• HBsAg loss/seroconversion

  HBsAg loss was defined as HBsAg levels \<0.05 IU/mL. Anti-HBs was measured using Architect i2000 kit,and anti-HBs \>10 mIU/L was considered positive.

  HBsAg level was lower than 0.05IU/mL after 96 weeks treatment

Study Arms (1)

peginterferon alpha 2a

EXPERIMENTAL

the inactive chronic HBsAg carriers were treated with peginterferon alpha 2a for 72 weeks and followed for 24 weeks.

Drug: Pegylated interferon alfa-2a

Interventions

Pegylated interferon alfa-2a DRUG

patients were given peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland)180 µg by subcutaneous injection once weekly for 120 weeks

Also known as: Pegasys®; Roche, Basel, Switzerland

peginterferon alpha 2a

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HBsAg positive and anti-HBs negative for more than 6 months
• HBeAg-negative/anti-HBe-positive
• Persistently undetectable HBV DNA with normal ALT levels, as established at 3-6 monthly intervals during the preceding 2 yrs
• Serum HBsAg levels ≤100 IU/mL, as determined on two occasions during the month prior to treatment
• Absence of previous antiviral therapy

You may not qualify if:

• With active alcohol and/or drugs consumption
• With human immunodeficiency virus or hepatitis C virus coinfections
• With clinical evidence of cirrhosis
• With history of autoimmune hepatitis
• With hematological or psychiatric diseases
• With evidence of neoplastic diseases
• With severe cardiac or pulmonary disease

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

liver disease center, Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yao Xie, phD/MD

  Liver diseases center, Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of division 4, liver diseases center

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 15, 2011
• Study Start: May 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

CN (1)