Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120796
Status:
TERMINATED
Last Update Posted:
2016-07-21
First Post:
2005-07-12
Brief Title:
Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection ANRS 12100 HEPADAK-2
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection
Status:
TERMINATED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor patient recrutment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic hepatitis B infection is a major public health issue in Senegal The study will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine 12 intra-muscular injections over a 6-month period to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative hepatitis B virus HBV infection and an increase in hepatic enzymes
Detailed Description:
Hepatitis B infection with a prevalence higher than 15 of positive Ag HBs subjects is a major public health issue in Senegal A program of treatment of patients presenting with hepatic disease is currently ongoing through a network of specialists in GI tract and liver diseases Hepatitis B is a real threat in the Senegalese population as showed in a pilot study HEPADAK I performed at the Dakar Hospital Principal DHP in Dakar among 100 blood donors and 50 patients with liver disease This study allowed us to better characterize the strains at the molecular level The aim of the project is to assess a pragmatic treatment strategy which can be applied to Senegal or other developing countries for patients requiring treatment A recent Japanese study performed in Ag HBe positive patients reported the interest of the combination of Lamivudine LAM and a therapeutic vaccine with the negativation of viral load in 100 of patients after one year of treatment It is important to show that such a treatment with 12 intra-muscular injections of the vaccine over a 6-month period is feasible in Africa and to assess the results of such a treatment in the Senegalese population which is mainly AgHBe negative
The study HEPADAK 2 is a randomized open label study which will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine 12 intra-muscular injections of Engerix B over a 6-month period to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative HBV infection and an increase in transaminases
Eligible patients have to be HIV HDV and HCV negative and will have to i give their written informed consent ii have a B hepatitis grade over or equal to F2 with the Metavir score DNA HBV greater than 105 copiesmL or 104 copiesmL if Ag Hbe - ALAT greater than 13 times the upper limit of the normal iii accept to have a liver biopsy and to be followed for this protocol at the DHP After a 3-month treatment with Lamivudine patients whose viral load is negative or at least decreased by 4 Log will be randomized to the same treatment for a further 9-month period or to the same treatment combined with 12 injections of vaccine over 6 months The main endpoints are undetectability of HBV DNA blood level 12 months after treatment initiation and 6 months after the end of the treatment Secondary endpoints will be HBV DNA blood levels at 3 6 9 and 12 months after the end of the treatment transaminases blood level Lamivudine treatment compliance the feasibility of the vaccine injections schedule safety AgHBe seroconversion in positive patients and negativation of AgHBs Two hundred ten patients have to be included 70 in the Lamivudine group and 140 in the Lamivudine vaccine group in order to show a difference of at least 20 in the percentage of patients with an undetectable viral load at 12 months 70 expected under Lamivudine monotherapy with a power of 90 an alpha risk equal to 5 and a bilateral test Patients with a virological failure will be maintained or retreated with Lamivudine For the patients with an YMDD mutation a treatment with Adefovir Dipivoxil will be possible Patients inclusion is planned to start in January 2005 and end after 12 or 18 months Patients will be treated during one year and followed one year without treatment in the study protocol and then will be managed if necessary
The study HEPADAK 2 is a randomized open label study which will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine 12 intra-muscular injections of Engerix B over a 6-month period to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative HBV infection and an increase in transaminases
Eligible patients have to be HIV HDV and HCV negative and will have to i give their written informed consent ii have a B hepatitis grade over or equal to F2 with the Metavir score DNA HBV greater than 105 copiesmL or 104 copiesmL if Ag Hbe - ALAT greater than 13 times the upper limit of the normal iii accept to have a liver biopsy and to be followed for this protocol at the DHP After a 3-month treatment with Lamivudine patients whose viral load is negative or at least decreased by 4 Log will be randomized to the same treatment for a further 9-month period or to the same treatment combined with 12 injections of vaccine over 6 months The main endpoints are undetectability of HBV DNA blood level 12 months after treatment initiation and 6 months after the end of the treatment Secondary endpoints will be HBV DNA blood levels at 3 6 9 and 12 months after the end of the treatment transaminases blood level Lamivudine treatment compliance the feasibility of the vaccine injections schedule safety AgHBe seroconversion in positive patients and negativation of AgHBs Two hundred ten patients have to be included 70 in the Lamivudine group and 140 in the Lamivudine vaccine group in order to show a difference of at least 20 in the percentage of patients with an undetectable viral load at 12 months 70 expected under Lamivudine monotherapy with a power of 90 an alpha risk equal to 5 and a bilateral test Patients with a virological failure will be maintained or retreated with Lamivudine For the patients with an YMDD mutation a treatment with Adefovir Dipivoxil will be possible Patients inclusion is planned to start in January 2005 and end after 12 or 18 months Patients will be treated during one year and followed one year without treatment in the study protocol and then will be managed if necessary
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