Ignite Creation Date:
2024-05-05 @ 10:53 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01205165
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2010-09-17
Brief Title:
An Open Label Multi Centre Phase IV Study of Adefovir Dipivoxil in Korean Patients With Chronic Hepatitis B CHB
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open Label Multicenter Phase IV Study of Adefovir Dipivoxil in Korean Patients With Chronic Hepatitis B CHB
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
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:
Objectives The primary study objective is to assess the antiviral effect of 12 weeks of adefovir dipivoxil treatment in Korean patients with chronic hepatitis B and compensated liver disease The secondary study objectives are to assess the antiviral effect clinical benefit and safety of 52 weeks of adefovir dipivoxil treatment
Endpoints The primary efficacy endpoint is Mean log10 reduction in serum HBV DNA level from baseline to Week 12
The secondary efficacy endpoints include a the proportion of patients achieving serum ALT normalization at Week 52 b other assessments of antiviral effects the proportion of patients achieving HBV DNA no less than 300 copies per mL at Week 52 cHBeAg loss HBeAg seroconversion HBsAg loss and HBsAg seroconversion dthe proportion of patients achieving serum ALT normalization at Week 12
Study Design This is an open label multi centre phase IV study for Korean patients with chronic hepatitis B and compensated liver disease assessing the antiviral effect of 12 weeks treatment of Adefovir dipivoxil as a primary objective and antiviral effect clinical benefit and safety of 52 weeks treatment as secondary objectives
Patients will be screened for eligibility criteria and the baseline visit for the treatment initiation should occur no more than 4 weeks after screening Total treatment period will be 52 weeks and patients will return to the clinic for assessments as scheduled during treatment period After the 52 week study period it is likely that the patient will benefit from continued treatment with commercial adefovir If in the investigators clinical judgement this is the case the investigator should ensure that a routine prescription is available in a timely manner and that no unnecessary interruption in treatment occurs
Study Population A minimum of 100 male or female Korean patients more than 18 years of age with HBeAg positive chronic hepatitis B and compensated liver disease who meet the eligibility criteria will be enrolled
Study Assessments and Procedures
Potential patients will be screened prior to study entry and eligible patients who have given their consent will have further baseline assessments Following the screening the first doses of study medications will be given at baseline and patients will return to the clinic for assessment as scheduled during treatment period Patients who discontinue treatment prematurely will be followed up every 4 weeks for 12 weeks following the withdrawal visit The following key assessment and or measurement will be made at one or more visits during the study See section 141 Appendix 1 Time and event schedule
Pregnancy test females of child-bearing potential only
Haematology and serum chemistry profile including prothrombin timePT and AFP
HBV DNA Roche COBAS AMPLICOR HBV MONITOR Test LLOD 300 copies per ml
Hepatitis B markers HBeAgAnti HBe will be tested if HBeAg is negative HBsAgAnti HBs will be tested if HBsAg is negative Investigational Products Adefovir dipivoxil 10mg tablets will be supplied by GlaxoSmithKline and presented as a white to off white round tablets packaged in the bottle containing 30 tablets
Endpoints The primary efficacy endpoint is Mean log10 reduction in serum HBV DNA level from baseline to Week 12
The secondary efficacy endpoints include a the proportion of patients achieving serum ALT normalization at Week 52 b other assessments of antiviral effects the proportion of patients achieving HBV DNA no less than 300 copies per mL at Week 52 cHBeAg loss HBeAg seroconversion HBsAg loss and HBsAg seroconversion dthe proportion of patients achieving serum ALT normalization at Week 12
Study Design This is an open label multi centre phase IV study for Korean patients with chronic hepatitis B and compensated liver disease assessing the antiviral effect of 12 weeks treatment of Adefovir dipivoxil as a primary objective and antiviral effect clinical benefit and safety of 52 weeks treatment as secondary objectives
Patients will be screened for eligibility criteria and the baseline visit for the treatment initiation should occur no more than 4 weeks after screening Total treatment period will be 52 weeks and patients will return to the clinic for assessments as scheduled during treatment period After the 52 week study period it is likely that the patient will benefit from continued treatment with commercial adefovir If in the investigators clinical judgement this is the case the investigator should ensure that a routine prescription is available in a timely manner and that no unnecessary interruption in treatment occurs
Study Population A minimum of 100 male or female Korean patients more than 18 years of age with HBeAg positive chronic hepatitis B and compensated liver disease who meet the eligibility criteria will be enrolled
Study Assessments and Procedures
Potential patients will be screened prior to study entry and eligible patients who have given their consent will have further baseline assessments Following the screening the first doses of study medications will be given at baseline and patients will return to the clinic for assessment as scheduled during treatment period Patients who discontinue treatment prematurely will be followed up every 4 weeks for 12 weeks following the withdrawal visit The following key assessment and or measurement will be made at one or more visits during the study See section 141 Appendix 1 Time and event schedule
Pregnancy test females of child-bearing potential only
Haematology and serum chemistry profile including prothrombin timePT and AFP
HBV DNA Roche COBAS AMPLICOR HBV MONITOR Test LLOD 300 copies per ml
Hepatitis B markers HBeAgAnti HBe will be tested if HBeAg is negative HBsAgAnti HBs will be tested if HBsAg is negative Investigational Products Adefovir dipivoxil 10mg tablets will be supplied by GlaxoSmithKline and presented as a white to off white round tablets packaged in the bottle containing 30 tablets
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