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LDT600

Phase 1

Chronic Hepatitis B | Small molecule | Infectious Disease |Novartis AG|Last Updated: Dec 19, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

LDT600 · 1 trial · 1 indication

Phase 1 1
NCT00907894Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis BChronic Hepatitis B
COMPLETED22 Analytics
PHASE1COMPLETED
Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
Chronic Hepatitis B
NCT0090789422
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Study Endpoints

Primary Endpoints

LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC)
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.

Secondary Endpoints

Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events.
6 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Stratum 1EXPERIMENTAL -
Stratum 2EXPERIMENTAL -
Stratum 3EXPERIMENTAL -

Interventions

NameTypeDescription
LDT600 (Telbivudine)DRUGLDT600 (Telbivudine)
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Eligibility Criteria

Age Range2 Years to 18 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Children and adolescents patients * HBsAg seropositive Exclusion criteria: * 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 ...

Countries:BelgiumGermanyPhilippinesUnited Kingdom
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Frequently asked questions about LDT600

What is LDT600 used for?

LDT600 is an investigational small molecule being developed for chronic Hepatitis B. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied to evaluate its safety and pharmacokinetics in patients with this condition.

Who makes LDT600?

LDT600 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to assess the drug's potential as a treatment for chronic Hepatitis B.

What phase is LDT600 in?

LDT600 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The drug is being studied in early-stage trials to evaluate its safety, tolerability, and pharmacokinetic profile in humans.

What clinical trials is LDT600 in?

LDT600 has been studied in one completed Phase 1 clinical trial with the identifier NCT00907894. This trial, titled 'Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B,' enrolled 22 participants across Belgium, Germany, Philippines, and the United Kingdom.

Is LDT600 the same as telbivudine?

LDT600 is also known as telbivudine. The clinical trial NCT00907894, which studied LDT600, explicitly refers to telbivudine in its title, indicating that these names refer to the same drug substance. This is important for readers searching for either name.