Trial record 96 of 304 for:
hepatitis b | Recruiting, Not yet recruiting, Available Studies
Sustained Viral Response in Patients Achieved HBsAg Level≤100 IU/ml After Completed Interferon Treatment
This study is currently recruiting participants.
Verified August 2016 by Yao Xie, Beijing Ditan Hospital
First Posted: January 28, 2015
Last Update Posted: August 19, 2016
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Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital
Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and the ultimate treatment goal in CHB, However HBsAg loss occurred rarely by interferon treatment. Although It was reported that in nature history HBsAg level≤100 IU/ml can bring good long term outcomes in patients with chronic hepatitis B. it was not clear whether patients who achieved HBsAg level≤100 IU/ml by interferon treatment could maintain sustained viral response and the state of HBsAg level≤100 IU/ml.
||Observational Model: Cohort
Time Perspective: Prospective
||Sustained Viral Response and HBsAg Level Changes in Chronic Hepatitis B Patients Who Achieved HBsAg Level≤100 IU/ml After Completed Interferon Therapy
Primary Outcome Measures:
- the rate of sustained viral response [ Time Frame: 96 weeks ]
The serum HBV DNA will be tested every 3 month for 96 weeks after completed treatment in chronic hepatitis B patients who achieved serum HBsAg level≤100 IU/ml with HBV DNA undetectable by interferon therapy. The rate of sustained viral response defined HBV DNA level maintaining undetectable during observation period will be evaluated, and HBV reaction is defined as serum HBV DNA reverse back to detectable level.
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
The patients with chronic hepatitis B and achieved HBsAg level≤100 IU/ml after completed interferon treatment will be enrolled and observed for 96 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe will be measured every 3 months during the observation period, liver function tests were performed every 3 months also. The liver ultrasonic examination would be taken every 3-6 months. The primary endpoint is HBV DNA reaction. The secondary endpoints is HBsAg loss.
Information from the National Library of Medicine
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|Ages Eligible for Study:
||Child, Adult, Senior
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
the study population in this study were composed of patients who had chronic hepatitis B and achieved HBsAg level≤100 IU/ml with undetectable HBV DNA level after interferon treatment, and serum HBsAg and HBV DNA would be tested every 3 months for 96 weeks after finished treatment. Sustained viral response defined as serum HBV DNA maintaining undetectable during the observation period. HBsAg loss is defined as HBsAg level reached the value lower than the low limited value.
- patients who had chronic hepatitis B and achieved HBsAg level≤100 IU/ml with undetectable HBV DNA level by interferon treatment
- Active consumption of alcohol and/or drugs
- Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
- History of autoimmune hepatitis
- Psychiatric disease
- Evidence of neoplastic diseases of the liver
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348502
|liver disease center, Beijing Ditan Hospital
|Beijing, Beijing, China, 100015 |
|Contact: Yao Xie, phD/MD 8610-84322200 ext 2489 firstname.lastname@example.org |
Beijing Ditan Hospital
||Yao Xie, liver diseases center, Beijing Ditan Hospital
History of Changes
|Other Study ID Numbers:
||January 22, 2015
||January 28, 2015
|Last Update Posted:
||August 19, 2016
Keywords provided by Yao Xie, Beijing Ditan Hospital:
Additional relevant MeSH terms:
Hepatitis B, Chronic
Hepatitis, Viral, Human
Digestive System Diseases
RNA Virus Infections
DNA Virus Infections