Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489151
Status:
UNKNOWN
Last Update Posted:
2010-07-07
First Post:
2007-06-20
Brief Title:
A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy
Sponsor:
Hospital Authority Hong Kong
Organization:
Hospital Authority Hong Kong
Study Overview
Official Title:
A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2010-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Liver diseases due to hepatitis B reactivation are serious causes of morbidity and mortality in hepatitis B infected patients treated with chemotherapy We have previously shown that with pre-emptive use of lamivudine one can drastically reduce liver-related morbidity and mortality in such patients However due to the development of hepatitis B virus resistance to lamivudine some of these hepatitis B infected patients still develop hepatitis This is a research study aiming to compare the use of adefovir dipivoxil to lamivudine in hepatitis B infected patients treated with chemotherapy Both of these drugs have been approved for the treatment of the hepatitis B infection in the United States European Union and Hong Kong
All patients who were recruited in this study will receive study medication either lamivudine 100 mg daily or adefovir dipivoxil 10 mg daily to cover the entire period of chemotherapy for 72 weeks All patients will be follow-up for an additional 24 weeks thereafter Altogether 70 subjects will be recruited from Queen Mary Hospital Hong Kong SAR
This is an open-label study which means that the patients and the study doctor will know which treatment the subjects are assigned into If a subject decides to take part in the study and is found eligible heshe will be randomly like flipping of coin assigned to one of the following dose groups
Lamivudine 100 mg tablet Adefovir dipivoxil 10 mg tablet
All patients who were recruited in this study will receive study medication either lamivudine 100 mg daily or adefovir dipivoxil 10 mg daily to cover the entire period of chemotherapy for 72 weeks All patients will be follow-up for an additional 24 weeks thereafter Altogether 70 subjects will be recruited from Queen Mary Hospital Hong Kong SAR
This is an open-label study which means that the patients and the study doctor will know which treatment the subjects are assigned into If a subject decides to take part in the study and is found eligible heshe will be randomly like flipping of coin assigned to one of the following dose groups
Lamivudine 100 mg tablet Adefovir dipivoxil 10 mg tablet
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HARECCTR0500002 | None | None | None |