Hepatitis BPhase 3NCT00376259
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
A Phase 3 study testing telbivudine and adefovir dipivoxil in people with Hepatitis B, run by Novartis at 6 sites in 5 countries.
Trial summary
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus [HBV]) versus adefovir dipivoxil used alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- telbivudine and adefovir dipivoxil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Jan 2007to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented compensated chronic hepatitis B defined by a clinical history compatible with chronic hepatitis B.
- Previous or current lamivudine treatment
- HBV DNA > 6 log10 copies/mL
- Evidence of viral breakthrough
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Patient is pregnant or breastfeeding.
- Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
- Patient has received any anti-HBV treatment for HBV infection other than lamivudine in the 12 months before Screening for this study.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
United States2 sites
Novartis
San Diego, California
Study site
San Mateo, California
About this study
Official title: An Open-label, Multicenter, Randomized Study of Combination Therapy With Oral LDT600 (Telbivudine) Plus Adefovir Dipivoxil Versus Adefovir Dipivoxil Alone in HBeAg-positive Patients With Chronic Hepatitis B Who Are Lamivudine Resistant
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.
- Conditions
- Hepatitis B
- Being tested
- telbivudine, adefovir dipivoxil
- Keywords
- lamivudine resistance, Hepatitis B virus
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telbivudineDrug
600mg/day oral tablet for 96 weeks
adefovir dipivoxilDrug
10 mg of adefovir by mouth once daily
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy | Experimental | Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. Receives: Drug: telbivudine; Drug: adefovir dipivoxil |
| Adefovir monotherapy | Active comparator | Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks. Receives: Drug: adefovir dipivoxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Participants Who Experienced Virologic Breakthrough
Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.
Measured: 96 Weeks
Secondary outcomes (3)
Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration
Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment.
Measured: Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks
Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria
Undetectable HBV DNA = HBV DNA <300 copies/ml. Serum aminotransferase (ALT) normalization is defined as ALT within normal limits on 2 successive visits for a pt. with an elevated ALT level (>=1.0 x ULN) at baseline (BL). Hepatitis B e antigen (HBeAg) loss is defined as the loss of detectable serum HBeAg in a pt. who was HBeAg +ve at BL. HBeAg seroconversion is defined as HBeAg loss with detectable HBeAb. Hepatitis B surface antigen (HBsAg) loss is defined as the loss of detectable serum HBsAg in a pt. who was HBsAg +ve at BL. HBsAg seroconversion is defined as HBsAg loss with detectable HBsAb.
Measured: 12 week, 24 week, 48 week and 60 weeks
Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough
The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA). Patients did not receive 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startJan 2007
- Primary completionAug 2008
Why it stopped: The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis BStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376259
- Sponsor's protocol ID
- CLDT600A2304
- Status last verified
- Jun 2011
- First submitted
- 13 Sep 2006
- Last updated
- 30 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Randomized Study of Combination Therapy With Oral LDT600 (Telbivudine) Plus Adefovir Dipivoxil Versus Adefovir Dipivoxil Alone in HBeAg-positive Patients With Chronic Hepatitis B Who Are Lamivudine Resistant
- ClinicalTrials.gov ID
- NCT00376259
- Acronym / sponsor ID
- CLDT600A2304
- Conditions
- Hepatitis B
- Keywords
- lamivudine resistance, Hepatitis B virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA)
- Enrolment
- 43 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Aug 2008 (actual)
- First posted
- 14 Sep 2006 (estimated)
- Results
- Posted 17 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Experimental | Drug: telbivudine, Drug: adefovir dipivoxilCombination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. |
| Adefovir monotherapy | Active comparator | Drug: adefovir dipivoxilAdefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented compensated chronic hepatitis B defined by a clinical history compatible with chronic hepatitis B.
- Previous or current lamivudine treatment
- HBV DNA > 6 log10 copies/mL
- Evidence of viral breakthrough
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Patient is pregnant or breastfeeding.
- Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
- Patient has received any anti-HBV treatment for HBV infection other than lamivudine in the 12 months before Screening for this study.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| telbivudine600mg/day oral tablet for 96 weeks | Drug | Combination therapy |
| adefovir dipivoxil10 mg of adefovir by mouth once daily | Drug | Adefovir monotherapy, Combination therapy |
Primary outcome
The Proportion of Participants Who Experienced Virologic Breakthrough
Time frame: 96 Weeks
Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.
3 secondary outcomes
Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration
Time frame: Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks
Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria
Time frame: 12 week, 24 week, 48 week and 60 weeks
Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough
Time frame: Week 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatitis B
Active, not recruitingPhase 2
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing telbivudine and adefovir dipivoxil in people with Hepatitis B, run by Novartis at 6 sites in 5 countries.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 30 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 6 sites in United States, Hong Kong, South Korea, Taiwan, Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Proportion of Participants Who Experienced Virologic Breakthrough (time frame: 96 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 30 Jun 2011.