The aim of this study was to determine the effectiveness of regimens containing Direct Acting Antivirals (DAAs) in the treatment of chronic hepatitis C patients in Iran. Among the most critical inclusion criteria are the affirmation of infection with chronic hepatitis C by a detectable viral count and also unresponsiveness to previous interferon-based treatments or not being previously treated. Significant exclusion criteria include significant renal failure and advanced liver diseases. For 60 patients included in the study regarding the above-mentioned criteria, virus genotyping is carried out and they are treated with standardized protocols of DAAs made in Iran including daclatasvir, sofosbuvir and ledipasvir with or without interferon or ribavirin. The effectiveness of these regimens in the patients is assessed by determining their viral loads and alanine aminotransferase serum level and the data obtained is analyzed statistically.
General information
Acronym
DAAHepC
IRCT registration information
IRCT registration number:IRCT2017020210417N6
Registration date:2017-03-05, 1395/12/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-05, 1395/12/15
Registrant information
Name
Babak Sayad
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1823 3957
Email address
babaksayad@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Scieneces
Expected recruitment start date
2017-01-25, 1395/11/06
Expected recruitment end date
2018-01-26, 1396/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Direct-Acting Antiviral Regimens Effectiveness in Achieving Undetectable Viral Load in Chronic Hepatitis C Patients in Iran
Public title
The effect of generic drugs in treatment of chronic hepatitis C patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being diagnosed with hepatitis C and having a detectable viral count; Having not received any medications yet or being unresponsive to previous interferon-based treatments; Providing a freely signed consent form to be treated with new generic medications.
Exclusion criteria :Having a renal failure defined as eGFR
< 30 mL/min; Having a very advanced liver disease defined as MELD score > 20 or Child-Pugh score
> 12; Heart rate < 50 beats/min; History of previous treatment failure with sofosbuvir-based regimen; History of taking amiodarone within the last 6 months; Not consenting to participate in the study.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Kermanashah University of Medical Sciences
Street address
Kermanshah- Shahid Beheshti Bulevard- Building2-Vice – Chancellery of Research & Technology Affairs
City
Kermanshah
Postal code
6714673159
Approval date
2015-01-25, 1393/11/05
Ethics committee reference number
KUMS.REC.1395.630
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
Hepatitis C viral load
Timepoint
Beginig of treatment- one month after the begining of treatment- The end of treatment-Three months after the end of treatment
Method of measurement
Using Real Time PCR
2
Description
Hepatitis C virus genotype
Timepoint
at the beginning of treatment
Method of measurement
using gene sequencing
Secondary outcomes
1
Description
Alanin amino transferase (ALT)
Timepoint
At the beginning of treatment, then monthly for three months after the end of treatment
Method of measurement
Enzyme serum level
Intervention groups
1
Description
Sofosbuvir, tablet, 400mg, oral, once a day plus ribavirin, cap, 1000-1200 mg (per body weight), oral, daily plus IFN alpha 2b amp, 1.5 µg/Kg, daily, all for 3 months
* This regimen is used for genotypes 1 and 3 of hepatitis C
Category
Treatment - Drugs
2
Description
Ledipasvir/sofosbuvir, tablet, 90/400 mg, oral, once a day, all for 3 months
* In patients with cirrhosis ribavirin cap, 100-1200 mg daily is added to the above regimen
** This regimen is used for genotype 1 of hepatitis C
Category
Treatment - Drugs
3
Description
Daclatasvir, tablet, 60 mg, oral, once a day plus sofosbuvir, tablet, 400 mg, oral, once a day, all for 3 months
* In patients with cirrhosis ribavirin cap, 100-1200 mg daily is added to the above regimen
** This regimen is used for genotype 3 of hepatitis C
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Liver Disease Research Center and relate clinic
Full name of responsible person
Dr.Babak Sayad
Street address
Krmanshah- Imam Reza Hospital- third floor-Liver Disease Research Center
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kurosh Hamzehee
Street address
Kermanshah- Shahid Beheshti Bulevard- Building2-Vice – Chancellery of Research & Technology Affairs
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Norooznezhad
Position
Msc of medical immunology
Other areas of specialty/work
Street address
Kermanshah-Imam Reza Hospital- Liver Disease Research Center
City
Kermanshah
Postal code
Phone
+98 83 3437 6342
Fax
Email
fateme.noroznezhad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Babak Sayad
Position
associate professor of infectious disease
Other areas of specialty/work
Street address
Kermanshah- Imam Reza Hospital- Liver Disease Research Center
City
Kermanshah
Postal code
Phone
+98 83 3437 6342
Fax
Email
babaksayad@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Norooznezhad
Position
Msc of medical immunology
Other areas of specialty/work
Street address
Kermanshah- Imam Reza Hospital- Liver Disease Research Center
City
Kermanshah
Postal code
Phone
+98 83 3427 6342
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)