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IRCT20080901001155N30 IRCT 2018-10-24 Rasht University of Medical Sciences Efficacy of Daclatasvir and Sofosbuvir (Sovodak) in patients with HCV Efficacy of Daclatasvir and Sofosbuvir (Sovodak) with Ribavirin and without Ribavirin in cirrhosis and non cirrhosis patients with HCV in Gastrointestinal and Liver Disease Research Center in 2017 2017-11-04 anticipated 16 Complete https://irct.ir/trial/249 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: No comments. 3 Hepatitis C. Intervention 1: Intervention group: 1.intervention group is cirrhosis patients with hepatitis C that would take 12 weeks of Sofosbovir 400 mg and Daclatasvir 60 mg (Sovodak) 1 pill made by Abidi plus Ribavirin/day 1000 mg if the patients have less than 75 kg or 1200 mg/day if they have 75 kg or more (5 or 6 × 200 mg tablets in a divided daily dose) made by Bakhtar bioshimi. Intervention 2: Control group: 2. Control group is non-cirrhosis patients with hepatitis C that would take 12 weeks of Sofosbovir 400 mg and Daclatasvir 60 mg (Sovodak) 1 pill made by Abid. Yes - There is a plan to make this available What will be shared: The main outcome of this study is the hepatitis C treatment in Guilan cohort study , which will be available to the general public. When: A year after printing results To whom: Researchers at relevant research centers, universities, and related doctors Conditions: In this case, the decision has not yet been taken Where to obtain: Sara yeganeh Gastrointestinal and Liver Diseases Research Center, Razi hospital, Rasht 00981333535116 955655-41448 Yeganeh_sara6@yahoo.com How to obtain: At the outset, the applicant will email and complete his or her full introduction of the organization and the purpose of obtaining this data and will request the relevant documents or files.Subsequently, the data files will be made available to the applicant within the time period stated by the relevant investigator. Comments:
public Dr. Farahnaz Joukar
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue
Rasht Iran (Islamic Republic of) 41448956655 +98 13 3353 5116 farajov@yahoo.com Rasht University of Medical Sciences scientific Dr.Fariborz Mansour-Ghanaei
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue
Rasht Iran (Islamic Republic of) 41448956655 +98 13 3353 5116 ghanaie@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients who have not been treated before Patients who had been treated before, but their illness recurred Patients who could not take interferon 35 years 75 years Both Patients who did not use the medication completely Patients with severe drug side effects Patients who were reluctant to participate in the plan A00-B99 Chapter I Certain infectious and parasitic diseases,Viral hepatitis (B15-B19) Treatment - Drugs Treatment - Drugs Intervention group: 1.intervention group is cirrhosis patients with hepatitis C that would take 12 weeks of Sofosbovir 400 mg and Daclatasvir 60 mg (Sovodak) 1 pill made by Abidi plus Ribavirin/day 1000 mg if the patients have less than 75 kg or 1200 mg/day if they have 75 kg or more (5 or 6 × 200 mg tablets in a divided daily dose) made by Bakhtar bioshimi. Control group: 2. Control group is non-cirrhosis patients with hepatitis C that would take 12 weeks of Sofosbovir 400 mg and Daclatasvir 60 mg (Sovodak) 1 pill made by Abid HCV treatment. Timepoint: 12 weeks after the end of treatment. Method of measurement: HCV- RNA PCR. Possible side effect. Timepoint: Weeks 0.2, 4, 8, 12 and response to treatment, 24 weeks after the end of drug use (SVR 24. Method of measurement: weeks 2, 12 and 24 weeks after the end of drug use with use of PCR and 4,8 with use of liver enzymes test. Rasht University of Medical Sciences Approved 2017-10-07 Ethics Committee of Guilan University of Medical Sciences. Research and Technology Deputy ,Shaheed Beheshti street,Gaz square Rasht Guilan Iran (Islamic Republic of)