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
  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 ]

Estimated Enrollment: 818
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760122

  Hide Study Locations
Locations
China, Fujian
Xiamen Hospital of T.C.M Recruiting
Xiamen, Fujian, China, 361000
Contact: Wang Runhua, Ph.D    86-592-6889121    Clinical@amoytop.com   
China, Guangdong
Beijing University Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China, 518036
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
China
302 Military Hospital Recruiting
Beijing, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Peking University First Hospital Recruiting
Beijing, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Peking University People's Hospital Recruiting
Beijing, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Beijing Youyi Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Beijing Youan Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Beijing Ditan Hospital Capital Medical University Recruiting
Beijing, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
First Affiliated Hospital of Jilin University Recruiting
Changchun, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Xiangya Hospital, Central-south University Recruiting
Changsha, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Xiangya Second Hospital, Central-south University Recruiting
Changsha, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
West China Hospital, Sichuan University Recruiting
Chengdu, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Southwest Hospital Recruiting
Chongqing, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Second Affiliated Hospital Chongqing Medical University Recruiting
Chongqing, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Fuzhou Infectious Disease Hospital Recruiting
Fuzhou, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Guangzhou Eighth People's Hospital Recruiting
Guangzhou, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Nanfang Hospital Recruiting
Guangzhou, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Third Affiliated Hospital of Sun Yat-sen University Not yet recruiting
Guangzhou, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
First Affiliated Hospital of Guangxi Medical University Recruiting
Guilin, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
First Affiliated Hospital, Zhejiang University Recruiting
Hangzhou, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Second Affiliated Hospital of Harbin Medical University Recruiting
Harbin, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
First Affiliated Hospital of Anhui Medical University Not yet recruiting
Hefei, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Jinan Infectious Disease Hospital Recruiting
Jinan, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
First Affiliated Hospital of Lanzhou University Recruiting
Lanzhou, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
First Affiliated Hospital of Nanchang University Recruiting
Nanchang, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
81 Military Hospital Recruiting
Nanchang, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Second Hospital of Nanjing Recruiting
Nanjing, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Jiangsu Province Hospital Recruiting
Nanjing, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
85 Military Hospital Recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Shanghai Public Health Clinical Center Recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D    86-592-688912    clinical@amoytop.com   
Huashan Hospital Recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Renji Hospital Not yet recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Ruijing Hospital Recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Shengjing Hospital of China Medical University Recruiting
Shenyang, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Shenyang Sixed People's Hospital Recruiting
Shenyang, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Third Affiliated Hospital, Hebei Medical University Recruiting
Shijiazhuang, China
Contact: Wang Runhua, Ph.D    86-592-688912    clinical@amoytop.com   
First Affiliated Hospital, Shanxi University Recruiting
Taiyuan, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Tianjin Third Central Hospital Recruiting
Tianjin, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
First Affiliated Hospital of Wenzhou Medical College Recruiting
Wenzhou, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Tongji Hospital, Huazhong University of Science & Technology Not yet recruiting
Wuhan, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Union Hospital Tongji Medical College Huazhong University of Science and Technology Recruiting
Wuhan, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
First Affiliated Hospital of Xinjiang Medical University Recruiting
Wulumuqi, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Xijing Hospital Recruiting
Xi'an, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Tangdu Hospital, Fourth Military Medical University Recruiting
Xi'an, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
The First Affiliated Hospital of Xiamen University Recruiting
Xiamen, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
Henan Provincial People's Hospital Recruiting
Zhengzhou, China
Contact: Wang Runhua, Ph.D    86-592-6889121    clinical@amoytop.com   
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: November 28, 2013
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 B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Peginterferon alfa-2b
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014