Identification of drug resistence related mutations
Design
In this study 100 patients that met the inclusion criteria included thalassemia patients have history of chronic HCV (all genotypes) refered to Firoozgar Hospital; each participant specified a registry code.
Settings and conduct
Firoozgar Hospital and Gastrointestinal and Liver Diseases Research Center, Iran University,Tehran.
Participants/Inclusion and exclusion criteria
Thalassemia major patient that have chronic HCV infection, more than 18 years old, HCV/HBV co-infection, HCC or compensated cirrhosis without any limitation were included.
Intervention groups
Daclatasvir (60mg) plus Sofosbovir (400mg) per day 12W in non cirrhotic and 24W in compensated cirrhotic patient.
Main outcome variables
HCV Viral Load
General information
Reason for update
Acronym
TH-hepC-FS
IRCT registration information
IRCT registration number:IRCT20171125037624N2
Registration date:2018-01-26, 1396/11/06
Registration timing:registered_while_recruiting
Last update:2018-01-26, 1396/11/06
Update count:0
Registration date
2018-01-26, 1396/11/06
Registrant information
Name
Hossein Keyvani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 5350
Email address
keyvani.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Molecular investigation of hepatitis c virus before and after direct acting antiviral (DAA) therapy in thalasemia patients
Public title
Molecular investigation of hepatitis c virus before and after drug therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Thalassemia major patient that have chronic HCV infection more than 18 years old, HCV/HBV co-infection, HCC or compensated cirrhosis without any limitation were included.
Exclusion criteria:
Patients that have HIV/HCV co-infection and pregnant women were excluded.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
2
befor and after drug therapy
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower, Tehran, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-04-09, 1396/01/20
Ethics committee reference number
IR.IUMS.REC1396.30299
Health conditions studied
1
Description of health condition studied
Chronic viral hepatitis C
ICD-10 code
B18.2
ICD-10 code description
Chronic viral hepatitis C
Primary outcomes
1
Description
Viral Load
Timepoint
before and at the end of treatment
Method of measurement
quantitative evaluation viral particles
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Antiviral treatment with Sofosbuvir and Daclatasvir in all patients, Molecular survey on HCV before and after treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital and Gastrointestinal and Liver Diseases Research Center,
Full name of responsible person
Fahimeh Safarnezhad Tameshkel
Street address
Beh Afarin Street, Vali Asr Square, Firoozgar Hospital
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8893 7383
Email
Fahime.1615@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Hemat Highway next to Milad Tower, Tehran, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
malakoutik@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad hadi karbalaie niya
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Beh Afarin Street, Vali Asr Square, Firoozgar Hospital
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8893 7383
Email
mohamad.karbalai@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Hemat Highway next to Milad Tower, Tehran, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8893 7383
Email
keyvanlab@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fahimeh Safarnezhad Tameshkel
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Medical Genetics
Street address
Beh Afarin Street, Vali Asr Square, Firoozgar Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8893 7383
Email
fahime.1615@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available