Chronic Hepatitis BNCT01260610
Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients
A study testing Tenofovir, Telbivudine and Tenofovir plus Telbivudine in people with Chronic Hepatitis B, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Tenofovir, Telbivudine and Tenofovir plus Telbivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2011to Jun 2011
- Phase
- Interventional
- 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
- HBeAg negative at screening
- Documented chronic Hepatitis B
- Treatment naive
- Compensated liver disease
Who cannot join
- Chronic Hepatitis B with Child Pugh B \& C
- HBeAg positive
- Decompensated liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients
Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.
- Conditions
- Chronic Hepatitis B
- Being tested
- Tenofovir, Telbivudine, Tenofovir plus Telbivudine
- Keywords
- Hepatitis B, Tenofovir, Telbivudine
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenofovirDrug
300 mg of Tenofovir daily
TelbivudineDrug
600 mg of Telbivudine daily
Tenofovir plus TelbivudineDrug
Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir | Active comparator | Not described Receives: Drug: Tenofovir |
| Telbivudine | Active comparator | Not described Receives: Drug: Telbivudine |
| Tenofovir plus Telbivudine | Experimental | Not described Receives: Drug: Tenofovir plus Telbivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone
Measured: 6 Months and 2 Years
Secondary outcomes (6)
Percentage change in serum HBV DNA levels
Measured: Baseline and 2 Years
Percentage of patients with ALT normalization
Measured: Baseline and 2 Years
Percentage of patients with reduction in HBsAg concentration by >50%
Measured: Baseline and 2 Years
Percentage of patients with virological breakthrough
Measured: 24 weeks
Percentage of patients with primary treatment failure
Measured: 12 weeks
Occurrence of adverse events
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startJun 2011
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: lack of funds
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 Institute of Liver and Biliary Sciences, IndiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr S. K. Sarin, MD, DM, Principal investigator, Institute of Liver & Biliary Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260610
- Sponsor's protocol ID
- CLDT600AIN05T
- Status last verified
- Jun 2011
- First submitted
- 14 Dec 2010
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT01260610
- Acronym / sponsor ID
- CLDT600AIN05T
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B, Tenofovir, Telbivudine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Dec 2010 (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.
Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tenofovir | Active comparator | Drug: Tenofovir |
| Telbivudine | Active comparator | Drug: Telbivudine |
| Tenofovir plus Telbivudine | Experimental | Drug: Tenofovir plus 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)
- HBeAg negative at screening
- Documented chronic Hepatitis B
- Treatment naive
- Compensated liver disease
Key exclusion criteria (3 listed)
- Chronic Hepatitis B with Child Pugh B \& C
- HBeAg positive
- Decompensated liver 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 |
|---|---|---|
| Tenofovir300 mg of Tenofovir daily | Drug | Tenofovir |
| Telbivudine600 mg of Telbivudine daily | Drug | Telbivudine |
| Tenofovir plus TelbivudineTenofovir (300 mg daily) plus Telbivudine (600 mg daily) | Drug | Tenofovir plus Telbivudine |
Primary outcome
Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone
Time frame: 6 Months and 2 Years
6 secondary outcomes
Percentage change in serum HBV DNA levels
Time frame: Baseline and 2 Years
Percentage of patients with ALT normalization
Time frame: Baseline and 2 Years
Percentage of patients with reduction in HBsAg concentration by >50%
Time frame: Baseline and 2 Years
Percentage of patients with virological breakthrough
Time frame: 24 weeks
Percentage of patients with primary treatment failure
Time frame: 12 weeks
Occurrence of adverse events
Time frame: 2 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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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.
Dr S. K. Sarin, MD, DM principal investigator
Institute of Liver & Biliary Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir, Telbivudine and Tenofovir plus Telbivudine in people with Chronic Hepatitis B, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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: withdrawn, as of the sponsor's last update on 16 Jun 2015. 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 India. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone (time frame: 6 Months and 2 Years). 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 16 Jun 2015.