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Comparison of Pegylated Interferon alfa-2a plus Adefovir and Pegylated Interferon alfa-2a alone in the treatment of chronic hepatitis B with genotype D (multicenter study)

Protocol summary

Summary
In this multicenter double-blind study, we compare efficacy of Pegylated Interferon alfa-2a plus Adefovir and Pegylated Interferon alfa-2a alone in the treatment of chronic hepatitis B with genotype D in 74 patients. All patients who have chronic hepatitis B based on the liver biopsy, HBsAg positive for more than six months, ALT level more than 1/1 ULN and less than 10 ULN, more than 10000copies/ml, type D genotype will be enrolled in the study. Patients who have treated prior to study, receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are pregnant or breast fed, or refuse to sign informed consent will be excluded. These subjects will be allocated into study groups through simple randomization method. One group receives 180 µg/wk Pegylated Interferon alfa-2a plus 10 mg Adefovir and another group receives 180 µg/wk Pegylated interferon alfa-2a alone for 48 week. Patients will be followed for 24 week after treatment. We will compare two groups in terms of their response to treatment. The response to treatment is defined as decrease 2 score in hepatitis activity index, HBV-DNA>200 copies /ml and normal level of ALT

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138711201155N4
Registration date: 2009-05-02, 1388/02/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2009-05-02, 1388/02/12
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Gastrointestinal and Liver Diseases Research Center (GLDRC)
Expected recruitment start date
2009-03-09, 1387/12/19
Expected recruitment end date
2010-09-09, 1389/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Pegylated Interferon alfa-2a plus Adefovir and Pegylated Interferon alfa-2a alone in the treatment of chronic hepatitis B with genotype D (multicenter study)
Public title
Effect of Pegylated Interferon alfa-2a plus Adefovir in the treatment of chronic hepatitis B with genotype D
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of hepatitis B for more than 6 month, ALT more than 1/1 normal upper limit and less than 10 ULN, 18<age<65 years, Genotype D, HBV-DNA>10.000 copies/ml. Exclusion criteria: Receiving anti neoplasm, anti viral or immunomedulator drugs during 6 months prior to study, previous treatment, coinfection with Hepatitis A,C,D viruses or HIV, Severe dysfunction of liver and kidney, pregnancy, breast feeding, refusing to give informed consent .
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences, Gastrointestinal and Liver Diseases Research Center
Street address
Gastrointestinal and liver disease research center, Sardar Jangal Ave, Razi hospital, Rasht
City
Rasht
Postal code
41448-95655
Approval date
2009-03-03, 1387/12/13
Ethics committee reference number
143

Health conditions studied

1

Description of health condition studied
Chronic hepatitis B
ICD-10 code
B18.1
ICD-10 code description
Chronic viral hepatitis B without delta-agent

Primary outcomes

1

Description
Response to treatment
Timepoint
24 week after treatment
Method of measurement
HBV-DNA<200copies/ml measure with PCR

2

Description
Response to treatment
Timepoint
24 week after treatment
Method of measurement
normal level of ALT measure with Biochemical

Secondary outcomes

1

Description
Adverse effects
Timepoint
monthly
Method of measurement
Clinical evaluation and lab tests

Intervention groups

1

Description
180 µg/wk Pegylated Interferon alfa-2a plus 10 mg Adefovir for 48 week
Category
Treatment - Drugs

2

Description
180 µg/wk Pegylated Interferon alfa-2a and placebo for 48 week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Guilan University, Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr.Fariborz Mansour Ghanaei
Street address
Razi hospital, Sardar Jangal Ave.
City
Rasht

2

Recruitment center
Name of recruitment center
Mashhad University, Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr. Vosoghinia
Street address
City
Mashhad

3

Recruitment center
Name of recruitment center
Ghom University of Medical Sciences
Full name of responsible person
Dr. Mohamad Reza Ghadir
Street address
City
Ghom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Farahnaz Joukar
Street address
Razi Hospital, Sardare Jangal Ave.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Gastrointestinal and liver disease research center
Full name of responsible person
Farahnaz Joukar
Position
Assistant of Gastrointestinal and Liver Diseasea Research Center
Other areas of specialty/work
Street address
Razi hospital, Sardar Jangal Ave.
City
Rasht
Postal code
41448-95655
Phone
+98 13 1553 5116
Fax
+98 13 1553 4951
Email
f_jokar@gums.ac.ir
Web page address
www.gldrc.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gastrointestinal and liver disease research center
Full name of responsible person
Dr.Fariborz Mansour Ghanaei
Position
Professor of Internal Medicine & Gastroenterology
Other areas of specialty/work
Street address
Razi Hospital, Sardare Jangal Ave.
City
Rasht
Postal code
41448-95655
Phone
+98 13 1553 5116
Fax
+98 13 1553 4951
Email
ghanaei@gums.ac.ir
Web page address
www.gldrc.org

Person responsible for updating data

Contact
Name of organization / entity
Gastrointestinal and liver disease research center
Full name of responsible person
Dr.Helia Valaee Barhagh
Position
Researcher
Other areas of specialty/work
Street address
Razi hospital, Sardar Jangal Ave.
City
Rasht
Postal code
41448-95655
Phone
+98 13 1553 5116
Fax
+98 13 1553 4951
Email
h.barhagh79@gmail.com
Web page address
www.gldrc.org

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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