Chronic Hepatitis cPhase 2/3NCT03490097
Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination
A Phase 2/3 study testing Simvastatin 10mg and sofosbuvir plus daclatasvir in people with Chronic Hepatitis c and Metabolic Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of the study is to determine if statin can affect the clinical outcome of chronic hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Chronic Hepatitis c, Metabolic Syndrome
- What is being tested?
- Simvastatin 10mg and sofosbuvir plus daclatasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 23 May 2018
- Phase
- Phase 2/3
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients age 18 to 70 years old.
- Easy to treat group: treatment naïve patients with serum HCV RNA positivity by PCR.
- Clinically stable condition outpatients.
- Platelet count ≥ 150,000/mm³.
- INR ≤ 1.2.
- Serum albumin ≥ 3.5 g/dl.
- Total serum bilirubin ≤ 1.2 mg/dl.
Who cannot join
- Inadequately controlled diabetes mellitus (HbA1c > 9%) .
- Total serum bilirubin > 3mg/dl.
- HCV-HIV co infection.
- HBV-HCV co infection.
- Any cause for chronic liver disease other than hepatitis C
- Uncontrolled hypothyroidism.
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- Hepatocellular carcinoma, except 4 weeks 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.
- Child's C cirrhotic patients.
- Creatinine kinase > 350 u/l
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination
The purpose of the study is to determine if statin can affect the clinical outcome of chronic hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination
Read the detailed description
Aim of the work
To determine the benefits of statin use in CHC patients treated with Sofosbuvir/Daclatasvir/Ribavirin through :
Primary Outcome: Assessment of therapeutic SVR12
Seconadry Outcome
- assessment of Chronic hepatitis C(CHC) infection risk on development of metabolic syndrome through assessment of lipid profile , fasting glucose test , HgbA1C and C-reactive protein(CRP).
2- Evaluation of CHC related complications such as fibrosis and cirrhosis
Patients will be followed up for the whole study period and will be subjected to assessment of the following:
- CBC , liver function test , lipid profile and CK every month till the end of therapy.
- HgA1C and CRP at the end of therapy.
- HCV-PCR test 3 months after the end of therapy.
- Fibrosis using (FIB-4) 3 months after the end of therapy.
- Conditions
- Chronic Hepatitis c, Metabolic Syndrome
- Being tested
- Simvastatin 10mg, sofosbuvir plus daclatasvir
- Medical subject headings
- Hepatitis C, Chronic, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 10mgDrug
Also called simvastatin
tablets
sofosbuvir plus daclatasvirDrug
Also called Sovodac
sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | low dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks. Receives: Drug: Simvastatin 10mg; Drug: sofosbuvir plus daclatasvir |
| Group II | Active comparator | sofosbuvir plus daclatasvir Receives: Drug: sofosbuvir plus daclatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR 12
sustained virological response 3 months after the end of therapy
Measured: 3 months after end of therapy
Secondary outcomes (3)
Lipid marker
lipid profile
Measured: three months
Glycemic status marker
fasting glucose test
Measured: three months
inflammatory marker
C-reactive protein(CRP).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 Dec 2017
- Primary completion23 May 2018
- Study completion23 May 2018
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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mahmoud Shaheen, Ain Shams University
- Investigators
- Nagwa Ali Sabri, Professor, Study director, Professor of clinical pharmacy , ASU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490097
- Sponsor's protocol ID
- PHCL35
- Status last verified
- Sep 2018
- First submitted
- 19 Mar 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination
- ClinicalTrials.gov ID
- NCT03490097
- Acronym / sponsor ID
- PHCL35
- Conditions
- Chronic Hepatitis c, Metabolic Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 6 Apr 2018 (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.
The purpose of the study is to determine if statin can affect the clinical outcome of chronic hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination
Detailed description
Aim of the work
To determine the benefits of statin use in CHC patients treated with Sofosbuvir/Daclatasvir/Ribavirin through :
Primary Outcome: Assessment of therapeutic SVR12
Seconadry Outcome
- assessment of Chronic hepatitis C(CHC) infection risk on development of metabolic syndrome through assessment of lipid profile , fasting glucose test , HgbA1C and C-reactive protein(CRP).
2- Evaluation of CHC related complications such as fibrosis and cirrhosis
Patients will be followed up for the whole study period and will be subjected to assessment of the following:
- CBC , liver function test , lipid profile and CK every month till the end of therapy.
- HgA1C and CRP at the end of therapy.
- HCV-PCR test 3 months after the end of therapy.
- Fibrosis using (FIB-4) 3 months after the end of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Simvastatin 10mg, Drug: sofosbuvir plus daclatasvirlow dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks. |
| Group II | Active comparator | Drug: sofosbuvir plus daclatasvirsofosbuvir plus daclatasvir |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male patients age 18 to 70 years old.
- Easy to treat group: treatment naïve patients with serum HCV RNA positivity by PCR.
- Clinically stable condition outpatients.
- Platelet count ≥ 150,000/mm³.
- INR ≤ 1.2.
Key exclusion criteria (10 listed)
- Inadequately controlled diabetes mellitus (HbA1c > 9%) .
- Total serum bilirubin > 3mg/dl.
- 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 |
|---|---|---|
| Simvastatin 10mgAlso: simvastatintablets | Drug | Group I |
| sofosbuvir plus daclatasvirAlso: Sovodacsofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks. | Drug | Group I, Group II |
Primary outcome
SVR 12
Time frame: 3 months after end of therapy
sustained virological response 3 months after the end of therapy
3 secondary outcomes
Lipid marker
Time frame: three months
Glycemic status marker
Time frame: three months
inflammatory marker
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
Related trials for Chronic Hepatitis c
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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.
Nagwa Ali Sabri, Professor study director
Professor of clinical pharmacy , ASU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Simvastatin 10mg and sofosbuvir plus daclatasvir in people with Chronic Hepatitis c and Metabolic Syndrome, 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 7 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: finished, as of the sponsor's last update on 20 Sep 2018. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR 12 (time frame: 3 months after end of therapy). 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 20 Sep 2018.