Chronic Hepatitis BPhase 4Chinese PACNCT00781105
Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
A Phase 4 study testing Telbivudine in people with Chronic Hepatitis B, run by Novartis Pharmaceuticals at 1 site in China.
Trial summary
The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Telbivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2008to 16 Sep 2010
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female 16 to 65 year of age
- Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
- Willing and able to comply with the study drug regimen
- Written informed consent before any assessment
Who cannot join
- Patient has a history of/or clinical signs/symptoms of hepatic decompensation
- Patient has a history of HCC or findings suggestive of possible HCC
- Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
- History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
- Patient has received IFN or other immunomodulatory treatment with 12 months before screening
- Previous treatment history with NRTIs
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.
- Conditions
- Chronic Hepatitis B
- Being tested
- Telbivudine
- Keywords
- Chronic hepatitis B, Adult, HBV DNA suppression, Telbivudine
- 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.
TelbivudineDrug
600 mg/day, oral tablets, once daily, 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Telbivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA PCR negativity rate
Measured: at 52 weeks
Secondary outcomes (6)
HBV DNA PCR negativity rate
Measured: at week 24
DNA reduction
Measured: from baseline to Weeks 12, 24, 36, 52
HBeAg loss rate
Measured: at week 52
HBeAg seroconversion rate
Measured: at week 52
ALT normalization rate
Measured: at weeks 24 and 52
Incidence of AE (SAE,etc), Graded lab abnormalities
Measured: at week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study start1 Aug 2008
- Primary completion16 Sep 2010
- Study completion16 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jia Jidong, Dr., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781105
- Sponsor's protocol ID
- CLDT600ACN03
- Acronym
- Chinese PAC
- Status last verified
- Feb 2017
- First submitted
- 27 Oct 2008
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00781105
- Acronym / sponsor ID
- Chinese PAC / CLDT600ACN03
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic hepatitis B, Adult, HBV DNA suppression, Telbivudine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2008 (actual)
- Primary completion
- 16 Sep 2010 (actual)
- Study completion
- 16 Sep 2010 (actual)
- First posted
- 28 Oct 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.
The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Telbivudine |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 16 to 65 year of age
- Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
- Willing and able to comply with the study drug regimen
- Written informed consent before any assessment
Key exclusion criteria (7 listed)
- Patient has a history of/or clinical signs/symptoms of hepatic decompensation
- Patient has a history of HCC or findings suggestive of possible HCC
- Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
- History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
- Patient has received IFN or other immunomodulatory treatment with 12 months before screening
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 |
|---|---|---|
| Telbivudine600 mg/day, oral tablets, once daily, 52 weeks | Drug | 1 |
Primary outcome
HBV DNA PCR negativity rate
Time frame: at 52 weeks
6 secondary outcomes
HBV DNA PCR negativity rate
Time frame: at week 24
DNA reduction
Time frame: from baseline to Weeks 12, 24, 36, 52
HBeAg loss rate
Time frame: at week 52
HBeAg seroconversion rate
Time frame: at week 52
ALT normalization rate
Time frame: at weeks 24 and 52
Incidence of AE (SAE,etc), Graded lab abnormalities
Time frame: at week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Chronic Hepatitis B
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.
Jia Jidong, Dr. principal investigator
Beijing Friendship Hospital
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 Chronic Hepatitis B, run by Novartis Pharmaceuticals 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 7 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: finished, as of the sponsor's last update on 23 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV DNA PCR negativity rate (time frame: at 52 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 23 Feb 2017.