HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Beijing Ditan Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital
ClinicalTrials.gov Identifier:
NCT01471535
First received: October 31, 2011
Last updated: November 10, 2011
Last verified: November 2011

October 31, 2011
November 10, 2011
May 2008
December 2011   (final data collection date for primary outcome measure)
HBsAg loss/seroconversion [ Time Frame: HBsAg level was lower than 0.05IU/mL after 96 weeks treatment ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01471535 on ClinicalTrials.gov Archive Site
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HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated
HBsAg Loss/Seroconversion in Inactive Chronic Hepatitis B Carriers Treated With Peginterferon Alpha-2a

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.

Chronic HBV inactive carriers were enrolled in the out-patient department of Beijing Ditan Hospital. All of them were HBsAg positive and anti-HBs negative for more than 6 months with persistent undetectable HBV DNA and normal ALT levels measured at 3-6 monthly intervals during the preceding 2 years as well as with serum HBsAg levels ≤100 IU/mL determined on two occasions during the month prior to treatment. All patients did not have other liver diseases and contraindications for interferon therapy.

After giving informed consent, patients were treated with weekly subcutaneous injections of peginterferon alpha-2a 180 µg. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study.

In this study, the only parameter to assessing the treatment response was HBsAg level change. Treatment endpoint was HBsAg loss(<0.05 IU/mL) and anti-HBs positive(>10 mIU/mL) defined as seroconversion.

Depending on the decline of HBsAg level, treatment was either continued for a prolonged period until the endpoint was achieved, or terminated in case of nonresponse. Treatment was proceeded if HBsAg level continued to decline until HBsAg seroconversion was achieved and the anti-HBs level was above 200 mIU/ml. If the patients were not willing to extend treatment, the therapy was ended at the time of HBsAg loss, or stopped without further decline of HBsAg levels on three months treatment.

Liver function parameters, including ALT, aspartate aminotransferase (AST), albumin (ALB) and total bilirubin (Tbil) were examined using an automated biochemical analyzer. Peripheral blood neutrophil and platelet count were detected before treatment, and monitored during treatment with one to three month intervals, and base on the test results to adjust the next checking time. Quantitative HBV DNA testing was conducted using a commercially available real-time fluorescence quantitative PCR kit. HBsAg levels were quantified with Architect i2000 HBsAg quantitative assay (Abbott Laboratories) kit.

The main efficacy endpoints were HBsAg loss and seroconversion.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
Drug: Pegylated interferon alfa-2a
patients were given peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland)180 µg by subcutaneous injection once weekly for 120 weeks
Other Name: Pegasys®; Roche, Basel, Switzerland
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
April 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 60 Years
No
Contact: Yao Xie, phD/MD 8610-84322489 xieyao@public.bta.net.cn
China
 
NCT01471535
DTH-XY002
Yes
Yao Xie, Beijing Ditan Hospital
Beijing Ditan Hospital
Not Provided
Principal Investigator: Yao Xie, phD/MD Liver diseases center, Beijing Ditan Hospital
Beijing Ditan Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP