Compare the response to treatment in patients with newly diagnosed chronic hepatitis C (genotype І ) and patients without any response to previous treatments , with combination of sofosbuvir-daklatsvir
(1) The aim of this study was to compare the response to treatment in patients with newly diagnosed administration drug sovodak chronic hepatitis C genotype and patients with a previous treatment failure. (2)In this study, an experimental clinical trial carried out, (3) patients chronic hepatitis C infections with genotype one who refer Gastroenterology Clinics of Medical Sciences, 25 of people who ribavirin and interferon already had been in the first group and The 25 people who were newly diagnosed and had no previous treatment were selected in the second group. The two groups were matched for age, sex and diseases. (4) Inclusion criteria for this study, patients with HCV genotype HCV RNA in a headline above or positive and people who have detectable HCV RNA titers after previous treatment failure and relapse. Exclusion criteria from the study, those who sovodak therapy to stop for any reason, People infected with virus (HIV) simultaneously, chronic liver disease who are reason other than HCV. (5) Patients with drug therapy, Sofosbuvir daily oral dose of 400 mg and a dose of 60 mg daily Daklinza oral pharmaceutical composition sovodak for 12 weeks and (6) The results of treatment using HCV RNA at weeks 24,12,4 title will be monitored to determine response to therapy in each patient and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702016388N7
Registration date:2017-04-08, 1396/01/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-08, 1396/01/19
Registrant information
Name
Mohamadhossein Somi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 7499
Email address
somimh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Tabriz University of Medical Science
Expected recruitment start date
2016-11-12, 1395/08/22
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
Compare the response to treatment in patients with newly diagnosed chronic hepatitis C (genotype І ) and patients without any response to previous treatments , with combination of sofosbuvir-daklatsvir
Public title
Response to treatment in patients with chronic hepatitis C genotype and drug sovodak newly diagnosed patients with previous treatment failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: People with HCV genotype HCV RNA in a headline above or positive؛ People who have detectable HCV RNA titers after previous treatment failure and relapse patients.
Exclusion criteria: People who sovodak therapy to stop for any reason؛ People infected with virus (HIV) concurrently؛ There is no reason other than HCV patients with chronic hepatitis؛ People with hepatitis B concurrently؛ People who have undergone liver transplantation recently؛ People who have low life expectancy؛ There is no assurance that the cut intravenous drug users inject drugs؛ Patients who received Amiodarone in the last 6 months؛ Women who are pregnant or plan to become pregnant or are breastfeeding؛ Those who have allergies to Lactose (sovodak with Lactose).
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Central bulding of medical science university, St. Golgasht, St. Azadi ,Tabriz
City
Tabriz
Postal code
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.tbzmed.ac.ir.1395.871
Health conditions studied
1
Description of health condition studied
Chronic Hepatitis C
ICD-10 code
B18.2
ICD-10 code description
Chronic viral hepatitis C
Primary outcomes
1
Description
Hepatitis C RNA
Timepoint
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment
Method of measurement
Test
Secondary outcomes
1
Description
Liver Echogenicity
Timepoint
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment
Method of measurement
paraclinical tests
2
Description
Albumin
Timepoint
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment
Method of measurement
Test
3
Description
Portal vein diameter
Timepoint
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment
Method of measurement
Sonography
4
Description
Splenic vein diameter
Timepoint
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment
Method of measurement
Sonography
5
Description
Spleen size
Timepoint
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment
Method of measurement
Sonography
6
Description
INR
Timepoint
Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment
Method of measurement
Test
Intervention groups
1
Description
In the intervention group, patients with hepatitis C who were treated with other drugs and were facing defeat, Drug treatment, Sofosbuvir daily at a dose of 400 mg daily oral doses of 60 mg Daklinza oral pharmaceutical composition in a single pill called sovodak will receive for 12 weeks.
Category
Treatment - Drugs
2
Description
In the control group of patients with hepatitis C who have not previously undergone any treatment, Drug treatment, Sofosbuvir daily at a dose of 400 mg daily oral doses of 60 mg Daklinza oral pharmaceutical composition in a single pill called sovodak will receive for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences, Imam Reza Hospital
Full name of responsible person
Dr. Hosein Mehdipour
Street address
Endoscopy ward, First floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz, East Azarbaijan
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Vice chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
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 of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosein Somi
Position
Gastroentrology and hepatology/ Professor
Other areas of specialty/work
Street address
Endoscopy ward, First floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz
City
Tabriz
Postal code
Phone
+98 41333347554
Fax
Email
somimh@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosein Somi
Position
Gastroentrology and hepatology/ Professor
Other areas of specialty/work
Street address
Endoscopy ward, First floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz
City
Tabriz
Postal code
Phone
+98 41333347554
Fax
Email
somimh@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hosein Mehdipour
Position
Gastroentrology and hepatology assistant
Other areas of specialty/work
Street address
Endoscopy ward, First floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz, East Azarbaijan
City
Tabriz
Postal code
Phone
+98 41333347554
Fax
Email
hosein.mehdipour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)