Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver

Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B

Compensated Chronic Hepatitis B Clinical Trial

Official title:
A Single-arm, Multicenter, Open-label, 52-week Treatment, Extension Study to CLDT600ACN04 Study to Evaluate the Efficacy (Including Histological Improvement) and Safety in Fourth to Sixth Year of Telbivudine Treatment in Patients With Chronic Hepatitis B

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01088009` - Efficacy Optimizing Research of Lamivudine Therapy	Phase 4
	Withdrawn	`NCT00862706` - Efficacy of Telbivudine in Blacks/African Americans and Hispanics/Latinos With Compensated Chronic Hepatitis B During 52 Weeks	Phase 4

See also

Status

Clinical Trial

Phase

Completed

NCT01088009 - Efficacy Optimizing Research of Lamivudine Therapy

Phase 4

Withdrawn

NCT00862706 - Efficacy of Telbivudine in Blacks/African Americans and Hispanics/Latinos With Compensated Chronic Hepatitis B During 52 Weeks

Phase 4

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT00877149
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 4
Start date	March 2009

Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms