Effect of Combination Therapy with Ledipasvir and Sofosbuvir (Hepasbuvir Plus) with or without Ribavirin for Treatment of Iranian Patients with Genotype-1 Hepatitis C Virus Infection
This clinical trial study aims to evaluate the effect of combination therapy with ledipasvir and sofosbuvir (Hepasbuvir Plus) with or without ribavirin for treatment of Iranian patients with genotype-1 hepatitis C virus infection attending in clinics of Iran Hepatitis Network. Duration of treatment can be 12 or 24 weeks. Based on the presence or absence of cirrhosis and with consideration of related contraindications, patients can also receive Ribavirn. Finally after 12 weeks of end of treatment, overall response to therapy, effect of cirrhosis and history of previous treatment on response to therapy will be investigated.
General information
Acronym
HepCC-HCV2
IRCT registration information
IRCT registration number:IRCT2016050717413N15
Registration date:2017-04-24, 1396/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-24, 1396/02/04
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah Research Center for Gastroenterology and Liver (BRCGL) Diseases. Baqiyatallah University of Medical Sciences, Tehran, IR Iran
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Combination Therapy with Ledipasvir and Sofosbuvir (Hepasbuvir Plus) with or without Ribavirin for Treatment of Iranian Patients with Genotype-1 Hepatitis C Virus Infection
Public title
Effect of Combination Therapy with Ledipasvir and Sofosbuvir (Hepasbuvir Plus) for Treatment of Patients with Hepatitis C Infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Iranian patients with genotype-1 hepatitis C virus infection; with minimum age of 18 year old; with or without previous history of treatment (Peg-Interferon, Ribavirin, Protease inhibitors including: Telaprevir and Boceprevir); Compensated or Decompensated Cirrhosis;
Exclusion Criteria: Co-infection with HIV infection; Patients with thalassemia; Patients with hemophilia; Patients with history of chronic hemodialysis; patients with history of liver transplantation
Before starting therapy, 4 weeks after starting therapy, end of therapy, 4 weeks after end of therapy, 12 weeks after end of therapy
Method of measurement
Quantitative viral load in laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Treatment with daily single-dose of Hepasbuvir plus (400 mg sofosbuvir/90 mg ledipasvir) made in Danesh pharmaceutical developmental co. Ribavirn (200 mg) can be added to the treatment protocol (five or six capsules). Treatment length is 12 or 24-week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Iran Hepatitis Networks
Full name of responsible person
Mohammad Saeid Rezaee-Zavareh
Street address
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah Hospital, Mollasadra Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Med
Full name of responsible person
Seyed Moayed Alavian
Street address
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah Hospital, Mollasadra Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Med
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
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Med
Full name of responsible person
Mohammad Saeid Rezaee-Zavareh
Position
Clinical Researcher/MD
Other areas of specialty/work
Street address
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah Hospital, Mollasadra Avenue
City
Tehran
Postal code
Phone
+98 21 8861 4523
Fax
Email
Dr_Rezaee@Live.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Med
Full name of responsible person
Mohammad Saeid Rezaee-Zavareh
Position
Clinical Researcher/MD
Other areas of specialty/work
Street address
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah Hospital, Mollasadra Avenue
City
Tehran
Postal code
Phone
+98 21 8861 4523
Fax
Email
Dr_Rezaee@Live.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah Research Center for Gastroentrology and Liver Diseases, Baqiyatalalj University of Medi
Full name of responsible person
Mohammad Saeid Rezaee-Zavareh
Position
Other areas of specialty/work
Street address
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah Hospital, Mollasadra Avenue
City
Tehran
Postal code
Phone
+98 21 8861 4523
Fax
Email
Dr_Rezaee@Live.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)