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

Sun Yat-sen University logo

Sun Yat-sen University

Status

Unknown

Conditions

Hepatitis B

Treatments

Drug: Entecavir
Drug: Peginterferon alfa-2a

Study type

Interventional

Funder types

Other

Identifiers

NCT01599130
Zhangyufeng

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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 α

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

entecavir
Active Comparator group
Description:
patients continue to use entecavir
Treatment:
Drug: Entecavir
peg-interferon
Experimental group
Description:
patients switch to sequential peg-interferon α-2a
Treatment:
Drug: Peginterferon alfa-2a

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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