Chronic Hepatitis BPhase 1NCT00907894
Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
A Phase 1 study testing LDT600 (Telbivudine) in people with Chronic Hepatitis B, run by Novartis Pharmaceuticals at 7 sites in 4 countries.
Trial summary
This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- LDT600 (Telbivudine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Feb 2009to Mar 2012
- Phase
- Phase 1
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents patients
- HBsAg seropositive
Who cannot join
- Decompensated liver disease (Child-Turcotte-Pugh (CTP) Score≥7, Class B and C)
- Prior anti-HBV therapy within 30 days of study drug dosing.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Germany3 sites
Novartis Investigator Site
Frankfurt
Novartis Investigator Site
Starnberg
Novartis Investigator Site
Wuppertal
Philippines2 sites
Novartis Investigator Site
Manila
Novartis Investigator Site
Quezon City
About this study
Official title: A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Telbivudine (LDT600) in Children and Adolescents With Chronic Hepatitis B
This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.
- Conditions
- Chronic Hepatitis B
- Being tested
- LDT600 (Telbivudine)
- Keywords
- Chronic hepatitis B,, telbivudine,, pharmacokinetics,, safety,, tolerability,, pediatric
- 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.
LDT600 (Telbivudine)Drug
LDT600 (Telbivudine)
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1 | Experimental | Not described Receives: Drug: LDT600 (Telbivudine) |
| Stratum 2 | Experimental | Not described Receives: Drug: LDT600 (Telbivudine) |
| Stratum 3 | Experimental | Not described Receives: Drug: LDT600 (Telbivudine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC)
To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection.
Measured: 6 days
Secondary outcomes (1)
Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events.
To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907894
- Sponsor's protocol ID
- CLDT600A2104
- Other IDs
- EudraCT 2007-006218-40
- Status last verified
- Sep 2012
- First submitted
- 22 May 2009
- Last updated
- 19 Dec 2020
- Results posted
- No
Publications
Stein DS, Ke J, Uy G, Bosheva M, Qi Y, Praestgaard J; LDT600A2104 Study Team. Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of telbivudine in children and adolescents with chronic hepatitis B. Antimicrob Agents Chemother. 2013 Sep;57(9):4128-33. doi: 10.1128/AAC.00117-13. Epub 2013 Jun 17.
PubMed 23774433
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Telbivudine (LDT600) in Children and Adolescents With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00907894
- Acronym / sponsor ID
- CLDT600A2104
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic hepatitis B,, telbivudine,, pharmacokinetics,, safety,, tolerability,, pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2012 (actual)
- First posted
- 25 May 2009 (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.
This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stratum 1 | Experimental | Drug: LDT600 (Telbivudine) |
| Stratum 2 | Experimental | Drug: LDT600 (Telbivudine) |
| Stratum 3 | Experimental | Drug: LDT600 (Telbivudine) |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children and adolescents patients
- HBsAg seropositive
Key exclusion criteria (3 listed)
- Decompensated liver disease (Child-Turcotte-Pugh (CTP) Score≥7, Class B and C)
- Prior anti-HBV therapy within 30 days of study drug dosing.
- Other protocol-defined inclusion/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 |
|---|---|---|
| LDT600 (Telbivudine)LDT600 (Telbivudine) | Drug | Stratum 1, Stratum 2, Stratum 3 |
Primary outcome
LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC)
Time frame: 6 days
To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection.
1 secondary outcome
Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events.
Time frame: 6 days
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 19 Dec 2020.
- Derived from this study: PubMed 23774433Stein DS, Ke J, Uy G, Bosheva M, Qi Y, Praestgaard J; LDT600A2104 Study Team. Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of telbivudine in children and adolescents with chronic hepatitis B. Antimicrob Agents Chemother. 2013 Sep;57(9):4128-33. doi: 10.1128/AAC.00117-13. Epub 2013 Jun 17.
- Results for CLDT600A2104 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LDT600 (Telbivudine) in people with Chronic Hepatitis B, run by Novartis Pharmaceuticals at 7 sites in 4 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 2 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: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Philippines, Belgium, United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC) (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00907894, which also lists 1 linked publication.
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 19 Dec 2020.