Chronic Hepatitis CHCV DAASNCT04211844
Metabolic Changes in Chronic HCV Patients Receiving DAAS
An observational study of Chronic Hepatitis C, run by Ain Shams University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- sofosbuvir plus daclatasvir and Sofosbuvir plus Ledipasvir
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to Apr 2020
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
El Demerdash Hospital
Cairo, Abbasseya, 11588
Nehal Abdel Fattah, pharmB, +201065600196, nehal_gb@hotmail.com
About this study
Official title: Metabolic Changes in Chronic Hepatitis C Virus Patients Receiving Direct Acting Antivirals
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.
Read the 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.
- Conditions
- Chronic Hepatitis C
- Being tested
- sofosbuvir plus daclatasvir, Sofosbuvir plus Ledipasvir
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvir plus daclatasvirDrug
Also called Sovaldi Daklinza
50 patients in the first group will receive 400 mg sofosbuvir plus daclatasvir 60 mg once daily for 12 weeks.
Sofosbuvir plus LedipasvirDrug
Also called Harvoni
50 patients in the second group will receive 400 mg sofosbuvir plus ledipasvir 90 mg (Harvoni) once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: sofosbuvir plus daclatasvir | |
| 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. Receives: Drug: Sofosbuvir plus Ledipasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 %
Measured: 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
Measured: baseline, week 4 (during treatment), week 24 (after end of treatment)
Secondary outcomes (1)
Treatment Response
Sustained Virological Response at week 12 after end of treatment ( SVR 12)
Measured: 12 WEEKS after end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Oct 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Khaled Abdel Raouf Abdel Fattah, Ain Shams University
- Investigators
- Nehal Abdel Fattah, PharmB, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211844
- Sponsor's protocol ID
- 164
- Acronym
- HCV DAAS
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Changes in Chronic Hepatitis C Virus Patients Receiving Direct Acting Antivirals
- ClinicalTrials.gov ID
- NCT04211844
- Acronym / sponsor ID
- HCV DAAS / 164
- Conditions
- Chronic Hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sofosbuvir plus daclatasvir | – | Drug: sofosbuvir plus daclatasvir50 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 | – | Drug: Sofosbuvir plus Ledipasvir50 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sofosbuvir plus daclatasvirAlso: Sovaldi Daklinza50 patients in the first group will receive 400 mg sofosbuvir plus daclatasvir 60 mg once daily for 12 weeks. | Drug | sofosbuvir plus daclatasvir |
| Sofosbuvir plus LedipasvirAlso: Harvoni50 patients in the second group will receive 400 mg sofosbuvir plus ledipasvir 90 mg (Harvoni) once daily for 12 weeks. | Drug | sofosbuvir plus ledipasvir |
Primary outcome
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
1 secondary outcome
Treatment Response
Time frame: 12 WEEKS after end of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nehal Abdel Fattah, PharmB principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nehal Abdel Fattah, PharmB (+201065600196, nehal_gb@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Total Lipid Profile within 6 months (time frame: baseline, week 4 (during treatment), week 24 (after end of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.