Hepatitis B, ChronicPhase 4NCT00810524
Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection
A Phase 4 study testing lamivudine, Telbivudine and Enticavir in people with Hepatitis B, Chronic, run by Sun Yat-sen University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- lamivudine, Telbivudine and Enticavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2007to Jan 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HBsAg positive for more than 6 months.
- HBeAg positive.
- HBV DNA over 10E5 copies/ml.
Who cannot join
- Previous antiviral treatment for HBV.
- Co infection of HIV, HCV, HEV, HAV, or HAV.
- Evidence of hepatic carcinoma.
- Evidence of autoimmune disease.
- Evidence of thyroid disease.
- History of mental sickness.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The Third Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong
Gao zhiliang, M. D., +862085252037, zhanlianh@21cm.com
- Recruiting
Study site
Guangzhou, Guangdong
Gao zhiliang, M. D., +8685252037
gao zhiliang, doctor
About this study
Official title: Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection.
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.
- Conditions
- Hepatitis B, Chronic
- Being tested
- lamivudine, Telbivudine, Enticavir, Adefovir Dipivoxil Tablets
- Keywords
- Chronic hepatitis B, antiviral treatment, long term prognosis
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamivudineDrug
100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
TelbivudineDrug
600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
EnticavirDrug
0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
Adefovir Dipivoxil TabletsDrug
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: lamivudine; Drug: Telbivudine; Drug: Enticavir; Drug: Adefovir Dipivoxil Tablets |
| 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). Receives: Drug: lamivudine; Drug: Telbivudine; Drug: Enticavir; Drug: Adefovir Dipivoxil Tablets |
| 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). Receives: Drug: lamivudine; Drug: Telbivudine; Drug: Enticavir; Drug: Adefovir Dipivoxil Tablets |
| 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). Receives: Drug: lamivudine; Drug: Telbivudine; Drug: Enticavir; Drug: Adefovir Dipivoxil Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence rate of hepatic carcinoma
Measured: 10 years after treatment
incidence rate of liver cirrhosis
Measured: 10 years after treatment
incidence rate of fulminant hepatitis
Measured: 10 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Gao zhiliang, M. D., Study director, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810524
- Sponsor's protocol ID
- SunYat-senU 5010 Hepatitis B
- Status last verified
- Oct 2008
- First submitted
- 1 Dec 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection.
- ClinicalTrials.gov ID
- NCT00810524
- Acronym / sponsor ID
- SunYat-senU 5010 Hepatitis B
- Conditions
- Hepatitis B, Chronic
- Keywords
- Chronic hepatitis B, antiviral treatment, long term prognosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: lamivudine, Drug: Telbivudine, Drug: Enticavir, Drug: Adefovir Dipivoxil Tablets120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is lower than 80u/L (early antiviral treatment). |
| B | Active comparator | Drug: lamivudine, Drug: Telbivudine, Drug: Enticavir, Drug: Adefovir Dipivoxil Tablets120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is higher than 80u/L (regular antiviral treatment). |
| C | Experimental | Drug: lamivudine, Drug: Telbivudine, Drug: Enticavir, Drug: Adefovir Dipivoxil Tablets180 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). |
| D | Active comparator | Drug: lamivudine, Drug: Telbivudine, Drug: Enticavir, Drug: Adefovir Dipivoxil Tablets180 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). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- HBsAg positive for more than 6 months.
- HBeAg positive.
- HBV DNA over 10E5 copies/ml.
Key exclusion criteria (6 listed)
- Previous antiviral treatment for HBV.
- Co infection of HIV, HCV, HEV, HAV, or HAV.
- Evidence of hepatic carcinoma.
- Evidence of autoimmune disease.
- Evidence of thyroid disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lamivudine100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years. | Drug | A, B, C, D |
| Telbivudine600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years. | Drug | A, B, C, D |
| Enticavir0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years. | Drug | A, B, C, D |
| Adefovir Dipivoxil Tablets10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years. | Drug | A, B, C, D |
Primary outcome
incidence rate of hepatic carcinoma
Time frame: 10 years after treatment
incidence rate of liver cirrhosis
Time frame: 10 years after treatment
incidence rate of fulminant hepatitis
Time frame: 10 years after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gao zhiliang, M. D. study director
Third Affiliated Hospital, Sun Yat-Sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lamivudine, Telbivudine and Enticavir in people with Hepatitis B, Chronic, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gao zhiliang, M. D. (+862085252037, zhanlianh@21cn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence rate of hepatic carcinoma (time frame: 10 years after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2008.