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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Ypeginterferon alfa-2b Drug: Pegasys Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ypeginterferon Alfa-2b Drug: Ypeginterferon alfa-2b
sc, qw, 48 weeks.

Active Comparator: Pegasys Drug: Pegasys
sc, qw, 48 weeks.




Primary Outcome Measures :
  1. Proportion of patients with HBeAg seroconversion at week72 [ Time Frame: 24 weeks after the cessation of treatment ]

Secondary Outcome Measures :
  1. Proportion of Patients with HBeAg seroconversion at week 12,24,48 [ Time Frame: week 12, 24, 48 from treatment starting ]
  2. 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 ]
  3. Average of HBV DNA decline level at week 12, 24,48 and 72 [ Time Frame: week 12, 24, 48 and 72 from treatment starting ]
  4. 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 ]
  5. Proportion of patients with ALT normalization at week 12,24, 48 and 72. [ Time Frame: week 12, 24, 48 and 72 from treatment starting ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760122


Locations
Show Show 43 study locations
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Peking University First Hospital
Investigators
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Principal Investigator: Wang Guiqiang, Ph.D Peking University First Hospital
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Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01760122    
Other Study ID Numbers: TB1211IFN
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: March 2015
Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
peginterferon
HBeAg Positive
Chronic hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents