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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
Sponsor:
Information provided by (Responsible Party):
Nehal Khaled Abdel Raouf Abdel Fattah, Ain Shams University

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Hepatitis C Drug: sofosbuvir plus daclatasvir Drug: Sofosbuvir plus Ledipasvir

Detailed Description:

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 First 8 hours of fasting, a blood sample will be withdrawn for fasting blood sugar and glycated hemoglobin. At 12 hours of fasting, another sample will be withdrawn for lipid profile.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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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 %

  3. 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


Secondary Outcome Measures :
  1. Treatment Response [ Time Frame: 12 WEEKS after end of therapy ]
    Sustained Virological Response at week 12 after end of treatment ( SVR 12)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Male or female patients age 18 to 75 years old. Patients ≥ 65 years old should undergo cardiological assessment prior to therapy by ECG, echocardiography and cardiological consultaion.
  • Easy to treat group: treatment naïve patients with serum HCV RNA positivity by PCR.
  • Clinically stable condition.
  • Platelet count ≥ 150,000/mm³.
  • INR ≤ 1.2
  • Serum albumin ≥ 3.5 g/dl.
  • Total serum bilirubin ≤ 1.2 mg/dl.
  • eGFR > 30 ml/min

Exclusion Criteria:

  • Pregnancy or inability to use effective contraceptives.
  • Inadequately controlled diabetes mellitus (HbA1c > 9%)
  • HCV-HIV co infection.
  • HBV-HCV co infection.
  • Any cause for chronic liver disease other than hepatitis C
  • Hyper or hypothyroidism.
  • Hepatocellular carcinoma, except 6 months after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI)
  • Extra-hepatic malignancy except after two years of disease-free interval.
  • Fibrosis: FIB-4 index ≥ 3
  • Patients prescribed with lipid-lowering agents (statins).

Information from the National Library of Medicine

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


Contacts
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Contact: Nehal Abdel Fattah, PharmB +201065600196 nehal_gb@hotmail.com
Contact: Sara Zaki, PhD +201008742248 drsara61181@gmail.com

Locations
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Egypt
El Demerdash Hospital Recruiting
Cairo, Abbasseya, Egypt, 11588
Contact: Nehal Abdel Fattah, pharmB    +201065600196    nehal_gb@hotmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Nehal Abdel Fattah, PharmB Ain Shams University

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Responsible Party: Nehal Khaled Abdel Raouf Abdel Fattah, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT04211844    
Other Study ID Numbers: 164
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents