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IRCT201702016388N7 IRCT 2017-04-08 Vice Chancellor for Research of Tabriz University of Medical Sciences Response to treatment in patients with chronic hepatitis C genotype and drug sovodak newly diagnosed patients with previous treatment failure 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 2016-11-12 anticipated 50 Complete https://irct.ir/trial/6828 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Chronic Hepatitis C. Intervention 1: 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. Intervention 2: 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.
public Dr. Mohammad Hosein Somi
Endoscopy ward, First floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz
Tabriz Iran (Islamic Republic of) +98 41333347554 somimh@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Mohammad Hosein Somi
Endoscopy ward, First floor, Imam Reza Hospital, St. Golgasht, St.Azadi, Tabriz
Tabriz Iran (Islamic Republic of) +98 41333347554 somimh@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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). no limit no limit Both B18.2 Chronic viral hepatitis C Treatment - Drugs Treatment - Drugs 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. 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. Hepatitis C RNA. Timepoint: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment. Method of measurement: Test. Liver Echogenicity. Timepoint: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment. Method of measurement: paraclinical tests. Albumin. Timepoint: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment. Method of measurement: Test. Portal vein diameter. Timepoint: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment. Method of measurement: Sonography. Splenic vein diameter. Timepoint: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment. Method of measurement: Sonography. Spleen size. Timepoint: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment. Method of measurement: Sonography. INR. Timepoint: Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment. Method of measurement: Test. Vice Chancellor for Research of Tabriz University of Medical Sciences Approved 2016-11-09 Ethics Committee of Tabriz University of Medical Sciences Central bulding of medical science university, St. Golgasht, St. Azadi ,Tabriz Tabriz Iran (Islamic Republic of)