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

This study is currently recruiting participants.
Verified November 2013 by Xiamen Amoytop Biotech Co., Ltd.
Sponsor:
Collaborator:
Peking University First Hospital
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01760122
First received: December 30, 2012
Last updated: November 28, 2013
Last verified: November 2013

December 30, 2012
November 28, 2013
March 2013
June 2015   (final data collection date for primary outcome measure)
Proportion of patients with HBeAg seroconversion at week72 [ Time Frame: 24 weeks after the cessation of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01760122 on ClinicalTrials.gov Archive Site
  • Proportion of Patients with HBeAg seroconversion at week 12,24,48 [ Time Frame: week 12, 24, 48 from treatment starting ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Average of HBV DNA decline level at week 12, 24,48 and 72 [ Time Frame: week 12, 24, 48 and 72 from treatment starting ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of patients with ALT normalization at week 12,24, 48 and 72. [ Time Frame: week 12, 24, 48 and 72 from treatment starting ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
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.

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.

Not Provided
Interventional
Phase 3
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, 48 weeks.
  • Drug: Pegasys
    sc, qw, 48 weeks.
  • Experimental: Ypeginterferon Alfa-2b
    Intervention: Drug: Ypeginterferon alfa-2b
  • Active Comparator: Pegasys
    Intervention: Drug: Pegasys
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
818
December 2015
June 2015   (final data collection date for primary outcome measure)

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).
Both
18 Years to 65 Years
No
Not Provided
China
 
NCT01760122
TB1211IFN
No
Xiamen Amoytop Biotech Co., Ltd.
Xiamen Amoytop Biotech Co., Ltd.
Peking University First Hospital
Principal Investigator: Wang Guiqiang, Ph.D Peking University First Hospital
Xiamen Amoytop Biotech Co., Ltd.
November 2013

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