Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275652
Status:
COMPLETED
Last Update Posted:
2011-03-23
First Post:
2006-01-10
Brief Title:
A Comparison of the Drug Telbivudine LdT and Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Randomized Double-Blind Trial of Telbivudine LdT Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Participants 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 participants medical record
Participants will be involved for 2 years and 4 months
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 Participants 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 participants medical record
Participants will be involved for 2 years and 4 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None