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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01730508
First received: November 15, 2012
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

This multicenter, prospective, observational study will evaluate the use in clin ical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese patients with HBeAg negative chronic hepatitis B. Patients receiving Peg asys according to the local label will be followed for the duration of their tre atment 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 ]

Estimated Enrollment: 1000
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (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

Contacts
Contact: Reference Study ID Number: ML28516 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
China
Recruiting
Beijing, China, 100054
Recruiting
Beijing, China, 100011
Terminated
Beijing, China, 100730
Recruiting
Beijing, China, 100050
Recruiting
Beijing, China, 100083
Recruiting
Beijing, China, 100039
Recruiting
Changchun, China, 130021
Recruiting
Changchun, China
Recruiting
Changsha, China, 410013
Recruiting
Changsha, China, 410007
Recruiting
Changzhou, China, 213001
Recruiting
Chengdu, China, 610041
Recruiting
Chongqing, China, 400038
Recruiting
Chongqing, China
Recruiting
Chongqing, China, 400016
Terminated
Dalian, China, 116031
Recruiting
Foshan, China
Recruiting
Foushan, China
Recruiting
Fuzhou, China, 350025
Recruiting
Guangzhou, China, 510405
Recruiting
Guangzhou, China
Recruiting
Guangzhou, China, 510080
Recruiting
Guangzhou, China, 510515
Active, not recruiting
Guangzhou, China, 510630
Recruiting
Guangzhou, China, 510060
Recruiting
Guangzhou, China, 510180
Recruiting
Haikou, China, 570311
Recruiting
Hangzhou, China
Recruiting
Hangzhou, China, 310003
Recruiting
Harbin, China
Recruiting
Hefei, China, 230022
Recruiting
Huai'an, China, 223001
Recruiting
Jiangmen, China, 529000
Recruiting
Jiangyin, China
Recruiting
Jinan, China, 250021
Recruiting
Kunming, China, 650041
Recruiting
Lanzhou, China
Completed
Lianyungang, China, 222002
Recruiting
Liuzhou, China
Recruiting
LuZhou, China, 646000
Recruiting
Nanchang, China, 330002
Recruiting
Nanjing, China, 210024
Completed
Nanjing, China
Recruiting
Nanjing, China
Recruiting
Nanning, China, 530011
Recruiting
Nanning, China, 530021
Recruiting
Ningbo, China
Recruiting
Ordos, China
Recruiting
Qingdao, China, 266033
Recruiting
Shanghai, China, 201999
Recruiting
Shanghai, China, 200025
Recruiting
Shanghai, China, 201508
Recruiting
Shanghai, China
Recruiting
Shantou, China, 515041
Recruiting
Shen Yang, China, 110004
Recruiting
Shen Zhen, China, 518020
Recruiting
Shenyang, China
Recruiting
Shi Jiazhuang, China, 050000
Recruiting
Shijiazhuang, China
Recruiting
Shijiazhuang, China, 050031
Recruiting
Suining, China, 629000
Recruiting
Suzhou, China
Recruiting
Taiyuan, China
Recruiting
Taizhou, China, 225300
Recruiting
Tianjin, China
Recruiting
Tianjin, China, 300192
Recruiting
Urumqi, China
Recruiting
Urumqi, China, 830054
Recruiting
Wenzhou, China, 325200
Terminated
Wenzhou, China, 325000
Recruiting
Wenzhou, China, 325000
Recruiting
Wuhan, China, 430030
Recruiting
Wuxi, China, 214005
Recruiting
Xi'an, China, 710038
Recruiting
Xiamen, China
Recruiting
Xuzhou, China, 221004
Recruiting
Yancheng, China, 224005
Recruiting
Yangzhou, China, 225009
Recruiting
Yichang, China
Recruiting
Zhaoqing, China, 526020
Recruiting
Zhengzhou, China, 450003
Recruiting
Zhenjiang, China, 212005
Recruiting
Zhoushan, China, 316000
Recruiting
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: August 6, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014