Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B - Full Text View

Purpose

This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: Ypeginterferon alfa-2b Drug: Peginterferon alfa-2a	Phase 2

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 Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Patients With Chronic Hepatitis B

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Interferon Peginterferon Alfa-2a Recombinant Hepatitis B vaccine Hepatitis A Vaccines

U.S. FDA Resources

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

Primary Outcome Measures:

Efficacy [ Time Frame: week 24 from treatment start ] [ Designated as safety issue: Yes ]
- Average of HBV DAN decline level at week 24.
- Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.

Secondary Outcome Measures:

Efficacy [ Time Frame: week 12, 24, 48 from treatment start and week 24 after treatment ] [ Designated as safety issue: Yes ]
- Average of HBV DNA decline level at week 12, 48 and 72.
- Proportion of patients with HBV DNA undetectable at week 48 and 72.
- Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 48 and 72.
- Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 48 and 72.
- Proportion of patients with ALT normalization at week 24 and 48.

Enrollment:	205
Study Start Date:	July 2010
Study Completion Date:	April 2012
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 Ypeginterferon alfa-2b 90mcg per week	Drug: Ypeginterferon alfa-2b sc, qw, for 48 weeks.
Experimental: Group 2 Ypeginterferon alfa-2b 135mcg per week	Drug: Ypeginterferon alfa-2b sc, qw, for 48 weeks.
Experimental: Group 3 Ypeginterferon alfa-2b 180mcg per week	Drug: Ypeginterferon alfa-2b sc, qw, for 48 weeks.
Active Comparator: Group 4 Pegasys 180mcg per week	Drug: Peginterferon alfa-2a sc, qw, for 48 weeks. Other Name: Pegasys

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age:18~60 years.
Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
Serum HBsAg positive for at least 6 months.
Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).

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.
WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
Co-infection with HAV, HIV, HCV, HDV, HEV.
Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.
Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
Evidence of hepatic decompensation.
History of hypothyroidism or current treatment for thyroid disease.
Uncontrolled significant chronic medical conditions other than chronic hepatitis B, or other conditions which in the opinion of the investigator preclude enrollment into the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143662

Locations

China
Peking University First Hospital
Beijing, China
Beijing Youyi Hospital, Capital Medical University
Beijing, China
302 Military Hospital
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
Peking University People's Hospital
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
Fuzhou Infectious Disease Hospital
Fuzhou, China
Guangzhou Eighth People's Hospital
Guangzhou, China
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Nanfang 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
First Affiliated Hospital of Anhui Medical University
Hefei, China
Jinan Infectious Disease Hospital
Jinan, China
First Affiliated Hospital of Lanzhou University
Lanzhou, China
First Affiliated Hospital of Nanchang University
Nanchang, China
Second Hospital of Nanjing
Nanjing, China
Jiangsu Province Hospital
Nanjing, China
81 Military Hospital
Nanjing, China
Ruijin Hospital
Shanghai, China
Renji Hospital
Shanghai, China
Huashan Hospital
Shanghai, China
Changhai Hospital
Shanghai, China
85 Militay Hospital
Shanghai, China
Shanghai Public Health Clinical Center
Shanghai, China
Shenzhen Third People's Hospital
Shenzhen, 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
Tongji Hospital, Huazhong University of Science&Technology
Wuhan, China
Tangdu Hospital, Fourth Military Medical University
Xian, China
Henan Provincial People's Hospital
Zhengzhou, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China

Sponsors and Collaborators

Xiamen Amoytop Biotech Co., Ltd.

Peking University First Hospital

Investigators

Principal Investigator:

Wang Guiqiang, MD, PhD

Peking University First Hospital

More Information

No publications provided

Responsible Party:	Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01143662 History of Changes
Other Study ID Numbers:	TB1007IFN
Study First Received:	June 11, 2010
Last Updated:	January 31, 2013
Health Authority:	China: Food and Drug Administration

Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:

peginterferon
interferon
Pegasys

HBV
Hepatitis B
HBeAg positive

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013