Metabolic Changes in Chronic HCV Patients Receiving DAAS (HCV DAAS)
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|ClinicalTrials.gov Identifier: NCT04211844|
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment|
|Chronic Hepatitis C||Drug: sofosbuvir plus daclatasvir Drug: Sofosbuvir plus Ledipasvir|
The aim of this study is;
- To investigate and compare the changes in the total lipid profile and glycated hemoglobin (HbA1c) for chronic hepatitis C patients after receiving either one of two different direct antiviral regimens: sofosbuvir/daclatasvir and sofosbuvir/ledipasvir (Harvoni).
- To evaluate the impact of treatment response on the serial changes of serum lipid levels and glycated hemoglobin after receiving either of the two different direct antiviral regimens.
- To determine whether the change in the lipid profile and HbA1C is due to different antiviral regimens or due to different SVR rates.
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 First 8 hours of fasting, a blood sample will be withdrawn for fasting blood sugar and glycated hemoglobin. At 12 hours of fasting, another sample will be withdrawn for lipid profile.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:
- CBC, ALT, AST, total serum bilirubin, and creatinine will be done every 4 weeks (week 0, 4, 8, 12, 16, and 24)
- Complete lipid profile, fasting blood glucose, and HbA1c levels at baseline, during therapy (week 4), and at week 24 after discontinuation of therapy.
- Quantitative PCR for HCV RNA at week 0 and 24.
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||24 Weeks|
|Official Title:||Metabolic Changes in Chronic Hepatitis C Virus Patients Receiving Direct Acting Antivirals|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
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.
Drug: sofosbuvir plus daclatasvir
50 patients in the first group will receive 400 mg sofosbuvir plus daclatasvir 60 mg once daily for 12 weeks.
Other Name: Sovaldi Daklinza
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.
Drug: Sofosbuvir plus Ledipasvir
50 patients in the second group will receive 400 mg sofosbuvir plus ledipasvir 90 mg (Harvoni) once daily for 12 weeks.
Other Name: Harvoni
- Change from baseline Total Lipid Profile within 6 months [ Time Frame: baseline, week 4 (during treatment), week 24 (after end of treatment) ]serum cholesterol, High density lipoproteins, Low density lipoproteins, Triglycerides, very low density lipoprotein , all measured in mg/dL after 12 hours of fasting
- Change from baseline Glycosylated Hemoglobin within 6 months [ Time Frame: baseline, week 4 (during treatment), week 24 (after end of treatment) ]average level of blood sugar over the past 2 to 3 months, measured in percentage %
- Change from baseline Fasting Blood Glucose within 6 months [ Time Frame: baseline, week 4 (during treatment), week 24 (after end of treatment) ]measured as mg/DL after 8 hours of fasting
- Treatment Response [ Time Frame: 12 WEEKS after end of therapy ]Sustained Virological Response at week 12 after end of treatment ( SVR 12)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04211844
|Contact: Nehal Abdel Fattah, PharmBemail@example.com|
|Contact: Sara Zaki, PhDfirstname.lastname@example.org|
|El Demerdash Hospital||Recruiting|
|Cairo, Abbasseya, Egypt, 11588|
|Contact: Nehal Abdel Fattah, pharmB +201065600196 email@example.com|
|Principal Investigator:||Nehal Abdel Fattah, PharmB||Ain Shams University|