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

NCT ID: NCT00275652

Last Updated: 2011-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2007-08-31

Brief 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.

Detailed Description

This study is a randomized, double-blinded trial looking at the drug Telbivudine (LdT) and comparing it to the drug lamivudine in patients with chronic hepatitis B and evidence of Cirrhosis.

Interested participants will first be seen for a screening visit, to determine eligibility for the study. Participants will have a medical history taken along with a physical exam and a blood draw. Prior to receiving the study drug, participants may be required to have a liver biopsy. If one was done in the past 5 years, it may be possible to use the results of the previous biopsy. If participants are unable to have a liver biopsy due to medical reasons, an ultrasound, CT, or MRI scan may be done instead. If an imaging study has been done in the past two years, it may be possible to use the results from this test.

All eligible participants will be put into one of two groups by chance (as in the flip of a coin). One group will receive 600 mg of LdT (3 tablets) plus a lamivudine placebo capsule (1 sugar pill) daily. While the other group will be receiving 100 mg of lamivudine (1 capsule) plus 3 LdT tablets (3 sugar pills) daily. Participants will take the study drug daily for a total of 104 weeks (2 years).

Participants will return for clinic visits at weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 52, 60, 68, 76, 84, 92, 100, and 104. Participant's vital signs (temperature, pulse, weight) and blood samples will be collected at each visit.

If after one year of being on the drug, there is no hepatitis b found in your blood, you may be stopped from the study drug. Participants will continue to be required to return to the clinic for study visits so information can be continued to be collected and for your condition to be monitored. If future blood tests show that the hepatitis B virus returned, participants will be told to restart their study drug.

At the end of the 104 weeks or if the treatment was stopped early for any reason except a liver transplant, or if additional treatment was not chosen for hepatitis B, participants will be asked to return to the clinic once every four weeks for 4 months. For each return visit to the clinic, vital signs and blood samples will be collected and recorded. A physical exam will be at the last follow-up visit.

If the study was stopped due to a liver transplant, participants will be asked to return for clinic visits at 4 and 16 weeks after surgery. At these visits, no procedures will be done, but a review of the participant's medical record.

Participants will be involved for 2 years and 4 months.

Conditions

Hepatitis B; Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

LdT (Telbivudine) and lamivudine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Principal Investigators

W. Ray Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

207-04

Identifier Type: -

Identifier Source: org_study_id