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telbivudine or lamivudine

Phase 3

Chronic Hepatitis B | Small molecule | Infectious Disease |Novartis AG|Last Updated: Mar 20, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

telbivudine or lamivudine · 1 trial · 1 indication

Phase 3 1
NCT00057265A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis BChronic Hepatitis B
COMPLETED- Analytics
PHASE3COMPLETED
A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B
Chronic Hepatitis B
NCT00057265-
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Study Endpoints

Primary Endpoints

Primary efficacy endpoint: "therapeutic response", defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg.

Secondary Endpoints

Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
telbivudine or lamivudineDRUG -
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Eligibility Criteria

Age Range16 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Patient is pregnant or breastfeeding * Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HI...

Countries:United StatesSouth KoreaSpainThailandTurkey (Türkiye)United Kingdom
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Frequently asked questions about telbivudine or lamivudine

What is telbivudine or lamivudine used for?

Telbivudine or lamivudine is used for the treatment of chronic hepatitis B. It is a small molecule being developed by Novartis AG for this infectious disease indication. The drug is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved for use.

Who makes telbivudine or lamivudine?

Telbivudine or lamivudine is being developed by Novartis AG, a company traded under the ticker symbol NVS. The drug is a small molecule intended for the treatment of chronic hepatitis B and is currently in Phase 3 clinical trials.

What phase is telbivudine or lamivudine in?

Telbivudine or lamivudine is in Phase 3 clinical development for chronic hepatitis B. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 3 trial has been completed, and the drug remains under clinical investigation.

What clinical trials is telbivudine or lamivudine in?

Telbivudine or lamivudine has one completed Phase 3 clinical trial, identified as NCT00057265. This was a randomized, double-blind study comparing telbivudine (LdT) versus lamivudine in adults with compensated chronic hepatitis B. The trial was conducted in multiple countries, including the United States, South Korea, Spain, Thailand, Turkey, and the United Kingdom.

Is telbivudine or lamivudine the same as LdT?

Yes, telbivudine is also known as LdT. The clinical trial NCT00057265 is titled 'A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B,' confirming that LdT refers to telbivudine. Lamivudine is a separate drug used as a comparator in the trial.