Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2017-10-30
2019-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Non-Diabetic Hepatitis C infected patients
1. clinical examination,
2. measurement of weight (Kg), height (meter), and waist circumference (cm).
3. Calculation of the body mass index.
4. Ultrasound abdominal examination.
5. Laboratory Investigations including Complete blood count, Serum aspartate and alanine aminotransferases, serum albumin, serum bilirubin, serum gamma-glutamyl transpeptidase, and international normalization ratio. HCV-RNA quantification before treatment and 12 weeks after the end of therapy.. Serum lipid profile, fasting and post-prandial blood sugar, glycated hemoglobin A1c also included.
6. Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin).
7. Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment.
8. measurement of serum levels of resistin before and at 12 weeks after treatment.
Sofosbuvir 400 milligram
single daily dose of 400 milligrams
Daclatasvir 60 milligram
single daily dose of 60 milligrams for 12 weeks
Ribavirin 400 milligram
weight based dose, 1200 mg for weight \> 75 kilogram, and 1000 milligram if weight \< 75 kilograms for 12 weeks
Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab
single daily dose for 12 weeks
Interventions
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Sofosbuvir 400 milligram
single daily dose of 400 milligrams
Daclatasvir 60 milligram
single daily dose of 60 milligrams for 12 weeks
Ribavirin 400 milligram
weight based dose, 1200 mg for weight \> 75 kilogram, and 1000 milligram if weight \< 75 kilograms for 12 weeks
Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab
single daily dose for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-diabetic patients.
Exclusion Criteria
* Diabetes mellitus;
* Bbody mass index ≥ 30 Kg/M\*2;
* History of alcohol consumption;
* Endocrinopathies that may affect the glycemic homeostasis;
* Other known causes of chronic liver disease; Hepatic decompensation \[defined as history of gastrointestinal bleeding (melena and /or hematemesis), jaundice, coagulopathy, hepatic encephalopathy, and/or ascites\]; bleeding diathesis;
* Connective tissue diseases;
* Autoimmune diseases;
* Cardiac, respiratory or renal disease.
* Patient receiving immuno-modulatory therapy or drugs that affect the blood glucose levels such as steroids or beta-blockers.
18 Years
70 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Sameh A. Lashen
Associate Professor of Internal Medicine.
Locations
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Faculty of Medicine
Alexandria, , Egypt
Countries
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Other Identifiers
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020966
Identifier Type: -
Identifier Source: org_study_id
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