|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Sun Yat-sen University |
|---|---|
| Information provided by: | Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT00810524 |
Purpose
Influence of antiviral treatment to the long term prognosis of patients with chronic HBV infection. The aim of antiviral treatment for HBV is to reduce the long term severe complications. In this study, the investigators divided patients with chronic HBV infection into two groups, which start early antiviral treatment and conventional antiviral treatment respectively. All the patients will be followed for ten years. From this study, the investigators want to find out the optimal time for patients with chronic HBV infection to start antiviral treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B, Chronic |
Drug: lamivudine Drug: Telbivudine Drug: Enticavir Drug: Adefovir Dipivoxil Tablets |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection. |
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is lower than 80u/L (early antiviral treatment).
|
Drug: lamivudine
100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Telbivudine
600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Enticavir
0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
Drug: Adefovir Dipivoxil Tablets
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
|
|
B: Active Comparator
120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is higher than 80u/L (regular antiviral treatment).
|
Drug: lamivudine
100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Telbivudine
600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Enticavir
0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
Drug: Adefovir Dipivoxil Tablets
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
|
|
C: Experimental
180 subjects (have no family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is lower than 80u/L (early antiviral treatment).
|
Drug: lamivudine
100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Telbivudine
600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Enticavir
0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
Drug: Adefovir Dipivoxil Tablets
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
|
|
D: Active Comparator
180 subjects (have no family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is higher than 80u/L (regular antiviral treatment).
|
Drug: lamivudine
100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Telbivudine
600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Enticavir
0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
Drug: Adefovir Dipivoxil Tablets
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
|
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gao zhiliang, M. D. | +862085252037 | zhanlianh@21cn.com |
| Contact: Huang zhanlian, M. D. | +8685252046 | zhanlianh@21cn.com |
| China, Guangdong | |
| Recruiting | |
| Guangzhou, Guangdong, China | |
| Contact: Gao zhiliang, M. D. +8685252037 | |
| Principal Investigator: gao zhiliang, doctor | |
| The Third Affiliated Hospital Of Sun Yat-sen University | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Gao zhiliang, M. D. +862085252037 zhanlianh@21cm.com | |
| Study Director: | Gao zhiliang, M. D. | The Third Affiliated Hospital of Sun Yat-sen University |
More Information
| Responsible Party: | The Third Affliated Hospital of Sun Yat-sen University ( The Third Affliated Hospital of Sun Yat-sen University ) |
| Study ID Numbers: | SunYat-senU 5010 Hepatitis B |
| Study First Received: | December 1, 2008 |
| Last Updated: | December 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00810524 |
| Health Authority: | United States: Institutional Review Board; China: State Food and Drug Administration |
|
Chronic hepatitis B antiviral treatment long term prognosis |
|
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Hepatitis B, Chronic |
Hepatitis B Lamivudine Hepatitis, Viral, Human Adefovir dipivoxil DNA Virus Infections Adefovir |
|
Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Antiviral Agents Hepadnaviridae Infections Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors |
