Purpose and design of the study: The effect of adding Irbesartan to Pegylated Interferon-alpha-2a in patients with HBeAg negative chronic hepatitis B Co-infected with hepatitis D. Randomized, single-blind, phase II clinical trials. Population of study and procedure: 45 registered patients in Imam Khomeini hospital hepatitis clinic with the main criteria for inclusion: chronic hepatitis B (HBs Ag positive during at least past 6 months) and infection with hepatitis D virus (anti-HDV positive antibodies) for at least 3 months and positive for HDV -RNA in screening period; HBe Ag negative; All women during fertility period should have a negative pregnancy test before registeration; Ability to provide written informed consent to participate in the study; and the main exclusion criteria: untreated liver disease; co-infection with hepatitis C or HIV; creatinine clearance <60 ml / min; Patients who are allergic to one of the Irbesartan components; pregnancy and lactation; patients with SBP <110 mm Hg or history of hypotension at any time; are allocated randomly in 3 groups: administration of Irbesartan before treatment followed by Pegylated interferon alfa-a2 versus a combination of both drugs versus Pegylated interferon alfa-a2 alone for 18 months. The serum level of HBsAg is measured after 3 months and 18 months. Outcomes of the study: Adding Irbesartan associates with a low level of serum HBsAg , at least 0.5 log / IU / ml, after 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071128308N3
Registration date:2017-08-08, 1396/05/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-08, 1396/05/17
Registrant information
Name
Ali Asadollahi Amin
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 0856
Email address
emadiham@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Tehran University of Medical Sciences
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding Irbesartan to Pegylated Interferon-alpha-2a in Patients With HBeAg Negative Chronic Hepatitis B Co-infected With Hepatitis D
Public title
The effect of your Irbesartan drug in treatment of hepatitis B and D
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: chronic hepatitis B with HBsAg present at least 6 months before screening and infection with hepatitis D virus as anti-HDV positive antibodies for at least 3 months and positive for HDV-RNA in the screening period; HBeAg negative ; All women with fertility potential should have a negative pregnancy test before enrollment; ability to provide informed written consent to participate in the study.Exclusion criteria: untreated liver disease; co-infection with hepatitis C or HIV; Creatinine clearance <60 ml / min; Patients who are allergic to one of the Irbesartan components; Pregnancy and lactation; Patients with SBP <110 mm Hg or history of hypo tension at any time
Age
From 18 years old to 69 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is done by Permuted-6th block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hospital Ethics Committee Imam Khomeini, Tehran University of Medical Sciences
Street address
End of Keshavarz Blvd., Imam Khomeini Hospital .
City
Tehran
Postal code
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.2967
Health conditions studied
1
Description of health condition studied
Hepatitis B and D
ICD-10 code
B18.0
ICD-10 code description
Chronic viral hepatitis B with delta-agent
Primary outcomes
1
Description
HBsAg
Timepoint
Before study, 3 months after, 18 months after
Method of measurement
Blood test, in units per milliliter (IU / ml)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Administration of irbesartan tablet 300 mg daily prior to treatment with pegylated interferon alpha-a2 for 24 weeks, followed by pegylated interferon alfa-a2 weekly at 180mcg alone for 48 weeks
Category
Treatment - Drugs
2
Description
Intervention group2: Concomitant administration of a daily dose of 300 mg of Irbesartan tablet and 180 mcg
pegylated alpha-a2 interferon for 24 weeks, followed by pegylated interferon alfa-a2 weekly at 180 mcg alone for 24 weeks
Category
Treatment - Drugs
3
Description
Intervention group3: Treatment with pegylated interferon alfa-a2 weekly at 180mcg alone for 48 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hepatitis clinic of Imam Khomeini Hospital.
Full name of responsible person
Miss Bayani
Street address
Imam Khomeini Hospital, End of Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Tehran University of Medical Sciences Headquarters, Keshavarz Blvd., First of Ghods St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Ali Asadollahi Amin
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, End of Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2811
Fax
Email
amiyaneh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Ali Asadollahi Amin
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, End of Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2811
Fax
Email
amiyaneh@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)