CompletedPhase 3

A Comparison of the Drug Telbivudine (LdT) and Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis.

United States6 participantsStarted 2004-06

Plain-language summary

This trial is being done to see if the investigational drug, LdT (Telbivudine), is safe and effective in the treatment of hepatitis B infection. In addition to this, we will be looking at the comparison of the effects (good and bad) of LdT and lamivudine.

Who can participate

Age range18 Years – 70 Years

SexALL

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Patients with chronic hepatitis b with evidence of cirrhosis, who are at least 18 to 70 years old, may be eligible to participate in this study.

What they're measuring

A composite endpoint called "clinical response" which is defined as HBV DNA <10 4 copies/ml and normal ALT and improvement, or stabilization in CTP score.

Durability of clinical response

Proportion of patients achieving improvement, stabilization, and worsening in CTP score

Proportion of patients with normal ALT

Improvements in serum albumin levels, in patients with hypoalbuminemia pre-treatment

Trial details

NCT IDNCT00275652

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-08

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