Liver CirrhosisPhase 4NCT01380951
Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)
A Phase 4 study testing telbivudine in people with Liver Cirrhosis and Chronic Hepatitis B, run by The Fifth People's Hospital of Suzhou at 1 site in China.
Trial summary
Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhosis, Chronic Hepatitis B
- What is being tested?
- telbivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Dec 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- liver cirrhosis with CHB
- without history of antiviral therapy or discontinued antiviral therapy for more than 6 months
- for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative
- for patients with uncompensated liver cirrhosis:HBV DNA positive
Who cannot join
- coinfection with HCV,HDV and HIV
- AFP≥100mg/L or HCC diagnosed by iconography
- with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Fifth People's Hospital of Suzhou
Suzhou, Jiangsu
Honghao Zhang, B.A., zhanghonghao@medmail.com.cn
Chuanwu Zhu, Doctor
About this study
Official title: Clinical Study of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B
Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.
Read the detailed description
Antiviral therapy on CHB patients with liver cirrhosis is compulsory and effective. Diseases development can be prevented or delayed if the virus is depressed successfully. Lamivudine is often used and usually has good efficacy. However, lamivudine resistance and virus mutation happens a lot. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.
- Conditions
- Liver Cirrhosis, Chronic Hepatitis B
- Being tested
- telbivudine
- Keywords
- liver cirrhosis, chronic hepatitis B, antiviral therapy, telbivudine
- Medical subject headings
- Liver Cirrhosis, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telbivudineDrug
Also called Sebivo
telbivudine 600mg/d 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| telbivudine | Experimental | Not described Receives: Drug: telbivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum HBV DNA
serum HBV DNA negativity and decline from baseline at week 48
Measured: 48 weeks
Secondary outcomes (2)
Serum HBeAg
rate of HBeAg seroconversion and HBeAg loss
Measured: 48 weeks
Child-pugh score
the average decline of Child-pugh score at week 48 from baseline
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fifth People's Hospital of Suzhou
- Sponsor type
- University, hospital or other
- Investigators
- Chuanwu Zhu, Doctor, Principal investigator, The Fifth People's Hospital of Suzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380951
- Sponsor's protocol ID
- szwy20110610
- Status last verified
- Jun 2011
- First submitted
- 23 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT01380951
- Acronym / sponsor ID
- szwy20110610
- Conditions
- Liver Cirrhosis, Chronic Hepatitis B
- Keywords
- liver cirrhosis, chronic hepatitis B, antiviral therapy, telbivudine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Fifth People's Hospital of SuzhouUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 27 Jun 2011 (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.
Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.
Detailed description
Antiviral therapy on CHB patients with liver cirrhosis is compulsory and effective. Diseases development can be prevented or delayed if the virus is depressed successfully. Lamivudine is often used and usually has good efficacy. However, lamivudine resistance and virus mutation happens a lot. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| telbivudine | Experimental | Drug: telbivudine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- liver cirrhosis with CHB
- without history of antiviral therapy or discontinued antiviral therapy for more than 6 months
- for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative
- for patients with uncompensated liver cirrhosis:HBV DNA positive
Key exclusion criteria (3 listed)
- coinfection with HCV,HDV and HIV
- AFP≥100mg/L or HCC diagnosed by iconography
- with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases
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 |
|---|---|---|
| telbivudineAlso: Sebivotelbivudine 600mg/d 96 weeks | Drug | telbivudine |
Primary outcome
Serum HBV DNA
Time frame: 48 weeks
serum HBV DNA negativity and decline from baseline at week 48
2 secondary outcomes
Serum HBeAg
Time frame: 48 weeks
Child-pugh score
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
Chuanwu Zhu, Doctor principal investigator
The Fifth People's Hospital of Suzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing telbivudine in people with Liver Cirrhosis and Chronic Hepatitis B, run by The Fifth People's Hospital of Suzhou at 1 site 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 4 inclusion and 3 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 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum HBV DNA (time frame: 48 weeks). 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 27 Jun 2011.