An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01730508
First received: November 15, 2012
Last updated: September 1, 2015
Last verified: September 2015
  Purpose

This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese patients with HBeAg negative chronic hepatitis B. Patients receiving Pegasys according to the local label will be followed for the duration of their treatment and for one year after cessation of treatment.


Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Incidence of HBsAg loss/seroconversion [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Incidence of normalization of serum ALT levels [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Dosage/schedule of Pegasys treatment in real-life clinical setting [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 970
Study Start Date: November 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Chinese patients with HBeAg negative chronic hepatitis B receiving treatment with Pegasys

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Treatment with Pegasys according to label and standard clinical practice
  • HBeAg negative serologically proven chronic hepatitis B with or without cirrhosis
  • Serum ALT > ULN (upper limit of normal) but </= 10 x ULN
  • HBV DNA >/= 2000 IU/mL

Exclusion Criteria:

  • Contraindications to Pegasys as detailed in the label
  • Co-infection with hepatitis A, hepatitis C or HIV
  • Pregnant or lactating women
  • Patients should not receive concomitant therapy with telbivudine
  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: NCT01730508

  Hide Study Locations
Locations
China
Baoding, China
Beijing, China, 100730
Beijing, China, 100011
Beijing, China, 100039
Beijing, China, 100050
Beijing, China, 100083
Beijing, China, 100054
Changchun, China, 130021
Changchun, China
Changsha, China, 410007
Changsha, China, 410013
Changzhou, China, 213001
Chengdu, China, 610041
Chongqing, China, 400010
Chongqing, China, 400016
Chongqing, China, 400038
Dalian, China, 116031
Foshan, China
Foushan, China
Fuzhou, China, 350025
Guangzhou, China
Guangzhou, China, 510060
Guangzhou, China, 510080
Guangzhou, China, 510180
Guangzhou, China, 510515
Guangzhou, China, 510630
Guangzhou, China, 510405
Haikou, China, 570311
Hangzhou, China
Hangzhou, China, 310003
Harbin, China
Hefei, China, 230022
Huai'an, China, 223001
Jiangmen, China, 529000
Jiangyin, China
Jinan, China, 250021
Kunming, China, 650041
Lanzhou, China
Lianyungang, China, 222002
Liuzhou, China
LuZhou, China, 646000
Nanchang, China, 330002
Nanjing, China, 210036
Nanjing, China
Nanjing, China, 210003
Nanning, China, 530011
Nanning, China, 530021
Ningbo, China
Ordos, China
Qingdao, China, 266033
Shanghai, China
Shanghai, China, 201508
Shanghai, China, 201999
Shanghai, China, 200025
Shantou, China, 515041
Shen Zhen, China, 518020
ShenYang, China, 110004
Shenyang, China
Shijiazhuang, China, 050082
Shijiazhuang, China, 050031
Suining, China, 629000
Suzhou, China
Taiyuan, China
Taizhou, China, 225300
Tianjin, China, 300192
Tianjin, China
Urumqi, China, 830001
Urumqi, China, 830054
Wenzhou, China, 325000
Wenzhou, China, 325200
Wuhan, China, 430030
Wuxi, China, 214005
Xi'an, China, 710038
Xiamen, China
Xingtai, China
Xuzhou, China, 221004
Yancheng, China, 224005
Yangzhou, China, 225009
Yichang, China
Zhaoqing, China, 526020
Zhengzhou, China, 450003
Zhenjiang, China, 212005
Zhoushan, China, 316000
Zhuhai, China, 519099
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01730508     History of Changes
Other Study ID Numbers: ML28516
Study First Received: November 15, 2012
Last Updated: September 1, 2015
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 02, 2015