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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-006218-40 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratum 1 | Experimental |
| |
| Stratum 2 | Experimental |
| |
| Stratum 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDT600 (Telbivudine) | Drug | LDT600 (Telbivudine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 days |
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Inclusion Criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Brussels | Belgium | ||||
| Novartis Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23774433 | Derived | 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. |
| Label | URL |
|---|---|
| Results for CLDT600A2104 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077712 | Telbivudine |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Frankfurt |
| Germany |
| Novartis Investigator Site | Starnberg | Germany |
| Novartis Investigator Site | Wuppertal | Germany |
| Novartis Investigator Site | Manila | Philippines |
| Novartis Investigator Site | Quezon City | Philippines |
| Novartis Investigator Site | Birmingham | United Kingdom |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |