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Observational Study to check metabolic changes between two different hepatitis C antiviral medication groups. This study will evaluate the impact of different treatments on Serum lipid changes, fasting blood glucose and glycated hemoglobin . It will determine if changes are due to different Antiviral regimens or due to different Sustained virological response rates.
The aim of this study is;
Recruitment will be based on reviewing newly admitted patients and choosing those who are treatment naive and easy to treat according to study inclusion criteria. Thorough check of patient file will be done before starting the study. Eligible patients will sign a consent before starting both the treatment and the study. Patients will be divided into two groups taking treatment for 12 weeks. After treatment, patients will be followed-up for up to 12 weeks.
Patients will be asked to fast for a total of 12 hours. First 8 hours of fasting, a blood sample will be withdrawn for fasting blood sugar and glycated hemoglobin. At 12 hours of fasting, another sample will be withdrawn for lipid profile.
At baseline, patients dermographics (sex, age, weight, height, BMI), full medication history and full medical history will be collected from both patient file and patient consultation. After end of treatment at week 24, weight will be measured and BMI will be also be calculated. Adverse effects reporting:Patients will be asked about any undesirable effects detected throughout the trial which would be reported.
For the whole study period, patients will be subjected to assessment of the following:
Results will be collected and tabulated in excel sheet to undergo statistical analysis. Statistical analyses will be done using the SPSS software (Statistical Package for the Social Sciences). Proportions will be compared using Fisher's exact test and means will be compared with Student's t-test or Wilcoxon rank sum test, where appropriate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sofosbuvir plus daclatasvir | 50 patients receiving 400 mg sofosbuvir plus daclatasvir 60 mg once daily for 12 weeks. Blood samples are taken at baseline (week 0), week 4 (during treatment) and week 24 (post treatment after discontinuation of treatment at sustained virological response). Samples will be evaluated for lipid profiles, fasting blood sugar and glycated hemoglobin. |
| |
| sofosbuvir plus ledipasvir | 50 patients receiving 400 mg sofosbuvir plus ledipasvir 90 mg (Harvoni) once daily for 12 weeks. Blood samples are taken at baseline (week 0), week 4 (during treatment) and week 24 (post treatment after discontinuation of treatment at sustained virological response). Samples will be evaluated for lipid profiles, fasting blood sugar and glycated hemoglobin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sofosbuvir plus daclatasvir | Drug | 50 patients in the first group will receive 400 mg sofosbuvir plus daclatasvir 60 mg once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Total Lipid Profile within 6 months | serum cholesterol, High density lipoproteins, Low density lipoproteins, Triglycerides, very low density lipoprotein , all measured in mg/dL after 12 hours of fasting | baseline, week 4 (during treatment), week 24 (after end of treatment) |
| Change from baseline Glycosylated Hemoglobin within 6 months | average level of blood sugar over the past 2 to 3 months, measured in percentage % | baseline, week 4 (during treatment), week 24 (after end of treatment) |
| Change from baseline Fasting Blood Glucose within 6 months | measured as mg/DL after 8 hours of fasting | baseline, week 4 (during treatment), week 24 (after end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response | Sustained Virological Response at week 12 after end of treatment ( SVR 12) | 12 WEEKS after end of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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The cases involved in the study will be recruited from El-Demerdash Ain Shams University Hospital in Cairo, Egypt. Patients will be followed up at the "HCV treatment unit Ain Shams University Hospital" for the whole study period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nehal Abdel Fattah, PharmB | Contact | +201065600196 | nehal_gb@hotmail.com | |
| Sara Zaki, PhD | Contact | +201008742248 | drsara61181@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nehal Abdel Fattah, PharmB | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Demerdash Hospital | Recruiting | Cairo | Abbasseya | 11588 | Egypt |
It is not yet known if there will be a plan to make IPD available.
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C549273 | daclatasvir |
| C586541 | ledipasvir |
| C000595958 | ledipasvir, sofosbuvir drug combination |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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|
| Sofosbuvir plus Ledipasvir | Drug | 50 patients in the second group will receive 400 mg sofosbuvir plus ledipasvir 90 mg (Harvoni) once daily for 12 weeks. |
|
|
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |