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

This study is ongoing, but not recruiting participants.
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: June 17, 2014
Last verified: November 2013
  Purpose

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 Intervention Phase
Chronic Hepatitis B
Drug: Ypeginterferon alfa-2b
Drug: Pegasys
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Xiamen Amoytop Biotech Co., Ltd.:

Primary Outcome Measures:
  • Proportion of patients with HBeAg seroconversion at week72 [ Time Frame: 24 weeks after the cessation of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 820
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ypeginterferon Alfa-2b Drug: Ypeginterferon alfa-2b
sc, qw, 48 weeks.
Active Comparator: Pegasys Drug: Pegasys
sc, qw, 48 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760122

Locations
China, Fujian
Xiamen Hospital of T.C.M
Xiamen, Fujian, China, 361000
China, Guangdong
Beijing University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
China
302 Military Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Beijing Youyi Hospital, Capital Medical University
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
Beijing Ditan Hospital Capital Medical University
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
Second Affiliated Hospital Chongqing Medical University
Chongqing, China
Fuzhou Infectious Disease Hospital
Fuzhou, China
Nanfang Hospital
Guangzhou, China
Guangzhou Eighth People's Hospital
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
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
Nanchang, China
Second Hospital of Nanjing
Nanjing, China
Jiangsu Province Hospital
Nanjing, China
Ruijing Hospital
Shanghai, China
Shanghai Public Health Clinical Center
Shanghai, China
85 Military Hospital
Shanghai, China
Huashan Hospital
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
Shenyang Sixed People's Hospital
Shenyang, 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
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Tongji Hospital, Huazhong University of Science & Technology
Wuhan, China
First Affiliated Hospital of Xinjiang Medical University
Wulumuqi, China
Xijing Hospital
Xi'an, China
Tangdu Hospital, Fourth Military Medical University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Henan Provincial People's Hospital
Zhengzhou, China
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Peking University First Hospital
Investigators
Principal Investigator: Wang Guiqiang, Ph.D Peking University First Hospital
  More Information

No publications provided

Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01760122     History of Changes
Other Study ID Numbers: TB1211IFN
Study First Received: December 30, 2012
Last Updated: June 17, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
peginterferon
HBeAg Positive
Chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, 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-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014