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

This study has been completed.
Sponsor:
Collaborator:
Idenix Pharmaceuticals
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275652
First received: January 10, 2006
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Hepatitis B
Cirrhosis
Drug: LdT (Telbivudine) and lamivudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Trial of Telbivudine (LdT) Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Time to clinical response
  • Duration of clinical response
  • Proportion of patients achieving improvement, stabilization, and worsening in CTP score
  • Improvement, stabilization, and worsening in a modified CTP score.
  • ALT normalization.

Estimated Enrollment: 6
Study Start Date: June 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275652

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Idenix Pharmaceuticals
Investigators
Principal Investigator: W. Ray Kim, M.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00275652     History of Changes
Other Study ID Numbers: 207-04
Study First Received: January 10, 2006
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Liver Cirrhosis
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Lamivudine
Telbivudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014