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

This study has been completed.
Sponsor:
Collaborator:
Peking University First Hospital
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01143662
First received: June 11, 2010
Last updated: January 31, 2013
Last verified: June 2010

June 11, 2010
January 31, 2013
July 2010
April 2011   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: week 24 from treatment start ] [ Designated as safety issue: Yes ]
  • Average of HBV DAN decline level at week 24.
  • Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.
Efficacy [ Time Frame: week 24 from treatment start ] [ Designated as safety issue: Yes ]
  • Proportion of patients with HCV RNA decline >2log10 at week 24 from treatment start.
  • Proportion of patients with HBeAg seroconversionat at week 24 from treatment start.
Complete list of historical versions of study NCT01143662 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: week 12, 24, 48 from treatment start and week 24 after treatment ] [ Designated as safety issue: Yes ]
  • 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.
Efficacy [ Time Frame: week 24, 48 from treatment start and week 24 after treatment ] [ Designated as safety issue: Yes ]
  • Proportion of patients with HBV DNA decline >2log at week 48 from treatment start and week 24 after treatment.
  • Proportion of patients with HBeAg seroconversion at week 48 from treatment start and week 24 after treatment.
  • Proportion of patients with HBsAg seroconversion at week 48 from treatment start and week 24 after treatment.
  • Proportion of patients with ALT normalization at week 24 and 48 from treatment start.
Not Provided
Not Provided
 
Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Patients With Chronic Hepatitis B

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: Ypeginterferon alfa-2b
    sc, qw, for 48 weeks.
  • Drug: Peginterferon alfa-2a
    sc, qw, for 48 weeks.
    Other Name: Pegasys
  • Experimental: Group 1
    Ypeginterferon alfa-2b 90mcg per week
    Intervention: Drug: Ypeginterferon alfa-2b
  • Experimental: Group 2
    Ypeginterferon alfa-2b 135mcg per week
    Intervention: Drug: Ypeginterferon alfa-2b
  • Experimental: Group 3
    Ypeginterferon alfa-2b 180mcg per week
    Intervention: Drug: Ypeginterferon alfa-2b
  • Active Comparator: Group 4
    Pegasys 180mcg per week
    Intervention: Drug: Peginterferon alfa-2a
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
April 2012
April 2011   (final data collection date for primary outcome measure)

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:

  • 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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01143662
TB1007IFN
Yes
Xiamen Amoytop Biotech Co., Ltd.
Xiamen Amoytop Biotech Co., Ltd.
Peking University First Hospital
Principal Investigator: Wang Guiqiang, MD, PhD Peking University First Hospital
Xiamen Amoytop Biotech Co., Ltd.
June 2010

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