|
 
- 现金
- 514 元
- 精华
- 0
- 帖子
- 279
- 注册时间
- 2011-8-19
- 最后登录
- 2015-5-29
|
Eligibility
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Key Inclusion Criteria:
Have a diagnosis of HBeAg negative, immune active, chronic HBV infection and all of the following:
History of being HBsAg positive at 2 time points > 6 months apart
HBsAg titer > 1,000 IU/mL determined at screening
HBeAg negative at screening
HBV DNA < 200 IU/mL at screening
Patients with > 6 months of continuous, 0.5 mg/day oral entecavir, and a willingness to continue taking entecavir throughout the study.
Key Exclusion Criteria:
Female patients that have a positive pregnancy test or are lactating.
Acute signs of hepatitis/other infection (eg, moderate fever, jaundice, nausea, vomiting, and abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
Hepatic transaminases (ALT or AST) > 100 IU/mL at screening.
Patients with antiviral therapy other than entecavir within 3 months of screening or prior treatment with interferon or a toll receptor agonist in the last 5 years.
Use within the last 6 months or an anticipated requirement for anticoagulants, corticosteroids, immunomodulators, or immunosuppressants.
Has any history of autoimmune disease especially autoimmune hepatitis.
Has human immunodeficiency virus (HIV) infection, as shown by the presence of anti-HIV antibody (sero-positive).
Is sero-positive for HCV, and/or a history of delta virus hepatitis.
Has a history of allergy to bee venom or history of hypersensitivity reaction requiring an emergency visit to a physician or hospital and/or requirement for treatment with steroids and/or epinephrine.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02065336
Contacts
Contact: Winnie Leung + 852 9646-3894 [email protected]
Contact: Diamond Martin +1 626 696 4704 [email protected]
Locations
Hong Kong
Queen Mary Hospital Not yet recruiting
Pokfulam, Hong Kong
Contact: Ringo Wu +852 2255-3579 [email protected]
Principal Investigator: Man-Fung Yuen, MD, PhD
Prince of Wales Hospital Not yet recruiting
Shatin, Hong Kong
Contact: Angel Chim +852 2632-3759 [email protected]
Principal Investigator: Henry Chan, MD
Sponsors and Collaborators
Arrowhead Research Corporation
ICON Clinical Research
Investigators
Study Chair: Bruce Given, MD Arrowhead Research Corporation
More Information
No publications provided
Responsible Party: Arrowhead Research Corporation
ClinicalTrials.gov Identifier: NCT02065336 History of Changes
Other Study ID Numbers: Heparc-2001
Study First Received: February 13, 2014
Last Updated: February 18, 2014
Health Authority: Hong Kong: Department of Health |
-
总评分: 现金 + 20
查看全部评分
|
楼主: 林伍伍
发表于 2014-2-7 16:57
