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CompletedNCT01143662Updated Feb 4, 2013

Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

A Phase 2 interventional study of Ypeginterferon alfa-2b and Peginterferon alfa-2a in Chronic Hepatitis B, sponsored by Xiamen Amoytop Biotech Co., Ltd.. Completed at 39 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-02-04.

Sponsored by Xiamen Amoytop Biotech Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
205
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.

02

Conditions studied

  • Chronic Hepatitis B

Keywords

  • peginterferon
  • interferon
  • Pegasys
  • HBV
  • Hepatitis B
  • HBeAg positive
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 205 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Xiamen Amoytop Biotech Co., Ltd. is the lead sponsor of 30 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age:18\~60 years.
  • Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
  • Serum HBsAg positive for at least 6 months.
  • Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
  • 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women.
  • Mental disorder or physical disability.
  • Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
  • WBC\<3000/mm3, or ANC \<1500/mm3, or PLT \<90,000/mm3.
  • Co-infection with HAV, HIV, HCV, HDV, HEV.
  • Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.
  • Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
  • Evidence of hepatic decompensation.
  • History of hypothyroidism or current treatment for thyroid disease.
  • Uncontrolled significant chronic medical conditions other than chronic hepatitis B, or other conditions which in the opinion of the investigator preclude enrollment into the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
205 participants (actual)

Study arms

  • Experimental
    Group 1

    Ypeginterferon alfa-2b 90mcg per week

    Drug: Ypeginterferon alfa-2b

  • Experimental
    Group 2

    Ypeginterferon alfa-2b 135mcg per week

    Drug: Ypeginterferon alfa-2b

  • Experimental
    Group 3

    Ypeginterferon alfa-2b 180mcg per week

    Drug: Ypeginterferon alfa-2b

  • Active comparator
    Group 4

    Pegasys 180mcg per week

    Drug: Peginterferon alfa-2a

Interventions

  • DrugYpeginterferon alfa-2b

    sc, qw, for 48 weeks.

  • DrugPeginterferon alfa-2a

    sc, qw, for 48 weeks.

    Also known as: Pegasys

06

What researchers measure

Primary outcomes

  1. Efficacy

    * Average of HBV DAN decline level at week 24. * Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.

    Time frame: week 24 from treatment start

Secondary outcomes

  1. Efficacy

    * Average of HBV DNA decline level at week 12, 48 and 72. * Proportion of patients with HBV DNA undetectable at week 48 and 72. * Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 48 and 72. * Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 48 and 72. * Proportion of patients with ALT normalization at week 24 and 48.

    Time frame: week 12, 24, 48 from treatment start and week 24 after treatment

07

Study locations

39 sites
  • 302 Military Hospital
    Beijing, China
  • Beijing Youan Hospital, Capital Medical University
    Beijing, China
  • Beijing Youyi Hospital, Capital Medical University
    Beijing, China
  • Peking University First Hospital
    Beijing, China
  • Peking University People's Hospital
    Beijing, China
  • First Affiliated Hospital of Jilin University
    Changchun, China
  • Xiangya Hospital, Central-south University
    Changsha, China
  • Xiangya Second Hospital, Central-south University
    Changsha, China
  • West China Hospital, Sichuan University
    Chengdu, China
  • Southwest Hospital
    Chongqing, China
  • Fuzhou Infectious Disease Hospital
    Fuzhou, China
  • Guangzhou Eighth People's Hospital
    Guangzhou, China
  • Nanfang Hospital
    Guangzhou, China
  • Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, China
  • First Affiliated Hospital of Guangxi Medical University
    Guilin, China
  • First Affiliated Hospital, Zhejiang University
    Hangzhou, China
  • Second Affiliated Hospital of Harbin Medical University
    Harbin, China
  • First Affiliated Hospital of Anhui Medical University
    Hefei, China
  • Jinan Infectious Disease Hospital
    Jinan, China
  • First Affiliated Hospital of Lanzhou University
    Lanzhou, China
  • First Affiliated Hospital of Nanchang University
    Nanchang, China
  • 81 Military Hospital
    Nanjing, China
  • Jiangsu Province Hospital
    Nanjing, China
  • Second Hospital of Nanjing
    Nanjing, China
  • 85 Militay Hospital
    Shanghai, China
  • Changhai Hospital
    Shanghai, China
  • Huashan Hospital
    Shanghai, China
  • Renji Hospital
    Shanghai, China
  • Ruijin Hospital
    Shanghai, China
  • Shanghai Public Health Clinical Center
    Shanghai, China
  • Shenzhen Third People's Hospital
    Shenzhen, China
  • Third Affiliated Hospital, Hebei Medical University
    Shijiazhuang, China
  • First Affiliated Hospital, Shanxi University
    Taiyuan, China
  • Tianjin Third Central Hospital
    Tianjin, China
  • First Affiliated Hospital of Wenzhou Medical College
    Wenzhou, China
  • Tongji Hospital, Huazhong University of Science&Technology
    Wuhan, China
  • Tangdu Hospital, Fourth Military Medical University
    Xian, China
  • First Affiliated Hospital of Zhengzhou University
    Zhengzhou, China
  • Henan Provincial People's Hospital
    Zhengzhou, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01143662
Lead sponsor
Xiamen Amoytop Biotech Co., Ltd.
Collaborators
Peking University First Hospital
Responsible party
Sponsor
First posted
Jun 14, 2010
Start date
Jul 2010
Primary completion
Apr 2011
Completion
Apr 2012
Last update
Feb 4, 2013

Study contacts

Wang Guiqiang, MD, PhD
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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