In this study, thalassemia patients with hepatitis C have entered. These people have hepatitis C who have failed previous treatment have been cured. Patients with cirrhosis( the result of fibroscan) or not treated for 3 months (non-cirrhotic) and 6 months (in cirrhotic) The drug used in this study, Svbvsfvvyr (60 mg) once a day and Daklatasvyr (400 mg) once a day.During the study each month to tolerate treatment and side effects, patient follow-up will be. After completion of the treatment based on the result of counting the number of virus by PCR response to treatment is determined
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052426097N2
Registration date:2017-06-24, 1396/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-24, 1396/04/03
Registrant information
Name
Jamshid Vafaeemanesh
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 252931933
Email address
j.vafaeemanesh@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Iran University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of Sobiovir(Sofosbuvir) and Daklibiox (Daclatasvir) for treatment of Hepatitis C in patient with thalassemia
Public title
Effective treatment and sobaiovir and daclatasvir in treatment of Hepatitis C
Purpose
Treatment
Inclusion/Exclusion criteria
Persons with thalassemia major, which has a history of hepatitis C are and once in the past but failed treatment with interferon treatment were enrolled if they consent
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Iran university of medical sciences
Street address
Tehran - Hemmat - next to Milad Hospital
City
tehran
Postal code
Approval date
2017-04-24, 1396/02/04
Ethics committee reference number
IR.IUMS.REC1396.30169
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
The number of hepatitis C virus
Timepoint
18/5000 After treatment
Method of measurement
The number of virus by PCR
Secondary outcomes
1
Description
Complications of Treatment
Timepoint
Questionnaires and blood tests
Method of measurement
Blood samples and questionnaires of Complications , per month
Intervention groups
1
Description
Antiretroviral therapy in all patients with Daclatacvirr and sobaiovir - before and after treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Research Center of Iran University of Medical Sciences
Full name of responsible person
vafaeimanesh jamshid
Street address
City
firozgar hospital
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Iran University of Medical Sciences
Full name of responsible person
moosavi, alijavad,MD
Street address
Hemmat. Next to Milad Hospital. Iran University
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Iran 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
Iran university of medical silences
Full name of responsible person
vafaeimanesh jamshid
Position
Fellowship of Gastroenterology and Hepatology
Other areas of specialty/work
Street address
Firoozgar Hospital - Vali Asr Square - Division of Gastroenterology
City
tehran
Postal code
3716615476
Phone
+98 21 8894 0489
Fax
Email
jvafaeemanesh@yahoo.comj.vafaeemanesh@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom university of medical siences
Full name of responsible person
vafaeimanesh jamshid
Position
associate profesor
Other areas of specialty/work
Street address
firozgar hospital
City
tehran
Postal code
3716615476
Phone
+98 21 8894 0489
Fax
Email
jvafaeemanesh@yahoo.comj.vafaeemanesh@muq.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
iran university of medical silences
Full name of responsible person
vafaeimanesh jamshid ,MD
Position
felloship of Gastroenterology and Hepatology
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)