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

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ClinicalTrials.gov Identifier: NCT01760122
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : August 31, 2015
Sponsor:
Collaborator:
Peking University First Hospital
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.

Tracking Information
First Submitted Date  ICMJE December 30, 2012
First Posted Date  ICMJE January 3, 2013
Last Update Posted Date August 31, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2012)
Proportion of patients with HBeAg seroconversion at week72 [ Time Frame: 24 weeks after the cessation of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2012)
  • Proportion of Patients with HBeAg seroconversion at week 12,24,48 [ Time Frame: week 12, 24, 48 from treatment starting ]
  • Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72. [ Time Frame: week 4, 12, 24, 48 and 72 from treatment starting ]
  • Average of HBV DNA decline level at week 12, 24,48 and 72 [ Time Frame: week 12, 24, 48 and 72 from treatment starting ]
  • Average of HBsAg decline level at week 12, 24, 48 and 72, and Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 12, 24, 48 and 72. [ Time Frame: week 12, 24, 48 and 72 from treatment starting ]
  • Proportion of patients with ALT normalization at week 12,24, 48 and 72. [ Time Frame: week 12, 24, 48 and 72 from treatment starting ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
Official Title  ICMJE A Phase 3, Randomized, Multi-center, Active-controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Chinese Chronic Hepatitis B Patients.
Brief Summary This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis B
Intervention  ICMJE
  • Drug: Ypeginterferon alfa-2b
    sc, qw, 48 weeks.
  • Drug: Pegasys
    sc, qw, 48 weeks.
Study Arms  ICMJE
  • Experimental: Ypeginterferon Alfa-2b
    Intervention: Drug: Ypeginterferon alfa-2b
  • Active Comparator: Pegasys
    Intervention: Drug: Pegasys
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2014)
820
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2012)
818
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: 18~65 years.
  • Serum HBsAg or HBV DNA positive for at least 6 months.
  • Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening.
  • 2×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal).
  • Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment.

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.
  • ANC < 1500/mm3, or PLT < 90,000/mm3.
  • Co-infection with HAV, HIV, HCV, HDV, or HEV.
  • Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening.
  • Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil > 2ULN, Alb<35g/L).
  • Chronic hepatitis caused by any other reason except hepatitis B.
  • Hepatocarcinoma or suffering from any other malignant tumor.
  • Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus)
  • Significant function damage in any major organs (e.g.: heart, lung, kidney).
  • Other Conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760122
Other Study ID Numbers  ICMJE TB1211IFN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiamen Amoytop Biotech Co., Ltd.
Study Sponsor  ICMJE Xiamen Amoytop Biotech Co., Ltd.
Collaborators  ICMJE Peking University First Hospital
Investigators  ICMJE
Principal Investigator: Wang Guiqiang, Ph.D Peking University First Hospital
PRS Account Xiamen Amoytop Biotech Co., Ltd.
Verification Date March 2015

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