HCVNCT03820102
Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With HCV Infection Treated by DAAs
An observational study of HCV, run by Assiut University.
Trial summary
1. Study Changes in lipid profile and the impact of Insulin resistance on virological response in patients with Hepatitis C viral infection treated by Direct Acting Antiviral agents 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Oct 2019
- 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 years and older
- All sexes
- Adult, Older adult
Study population: 1. Full history and clinical evaluation. 2. Body weight and height 3. BMI will calculate as weight divided by squared height (kg/m2) 4. Waist circumference 5. Blood pressure (mmHg) Laboratory investigations will include: * Complete blood count (CBC) * Liver function test * HCV Ab and HCV RNA by PCR * HBs Ag * Alpha fetoprotein * Lipid profile * Serum urea and creatinine * Fasting blood sugar and Serum fasting insulin level * Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting insulin (µu/ml) × fasting glucose (mmol/L) 22.5 An index value of ˃ 2. 5 was defined as IR (Huang et al., 2011) * Vitamin D level: * Abdominal Ultrasound * Electrocardiogram
Who may be able to join
- Chronic HCV will receive DAAs for treatment
Who cannot join
- Decompensated liver cirrhosis, hepatocellular carcinoma, history of liver transplant
- Co-existing liver disease (hepatitis B virus, autoimmune hepatitis, human immunodeficiency virus)
- Extra-hepatic malignancy except after two years of disease free interval.
- Patients with diabetes mellitus.
- Patients with Chronic kidney disease.
- Pregnancy or in ability to use effective contraception.
- Patients with history of using lipid lowering therapy
- relapser or failure of previous HCV treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With Hepatitis C Viral Infection Treated by Direct Acting Antiviral Drugs
- Study Changes in lipid profile and the impact of Insulin resistance on virological response in patients with Hepatitis C viral infection treated by Direct Acting Antiviral agents
- The assessment of serum vitamin D levels in HCV infected patients and predictive value of pre-treatment serum vitamin D level for achieving sustained virological response at 12 weeks post-treatment
Read the detailed description
Patients and methods:
This cross-sectional study will include 100patients of chronic HCV infection who attend El Raghy Assiut university Hospital, either inpatients or outpatients. Chronic HCV infection will be diagnosed based on detectable HCV RNA with anti-HCV Ab in patient with clinical and/or ultrasonographic criteria of chronic liver disease.
Patients will receive treatment to HCV by DAAs and follow up for 12 weeks to confirm sustained virological response
Method:
Patients presenting in this study will be subjected to the following:
- Full history and clinical evaluation.
- Body weight (kg) and height (m).
- BMI will calculate as weight divided by squared height (kg/m2).
- Waist circumference will measured at a level midway between the lowest rib and the iliac crest, and the hip circumference at the level of the great trochanters, with the legs close together.
- Blood pressure (mmHg) was measured twice in the upper arm after a 10-min period of rest and taken an average.
Laboratory investigations will include:
- Complete blood count (CBC)
- Liver function test
- HCV Ab and HCV RNA by PCR
- HBs Ag
- Alpha fetoprotein
- Lipid profile
- Serum urea and creatinine
- Fasting blood sugar (FBG)and Serum fasting insulin level
- Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting insulin (µu/ml) × fasting glucose (mmol/L) ----------------------------------------------------------------- 22.5 An index value of ˃ 2. 5 was defined as IR (Huang et al., 2011)
- Vitamin D level:
Vitamin D deficiency wasdefined as a 25 (OH)-vitamin D serum level < 20 ng/mL, vitaminD insufficiency as 25 (OH)-vitamin D levels of 20 - 29.9ng/mL, and normal vitamin D levels ≥ 30 ng/mL (Holick MF et al.,2011)
- Abdominal Ultrasound
- Electrocardiogram (ECG)
- Conditions
- HCV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vit D deficiency | Chronic HCV patients with vitamin D deficiency Sustained virological response after treatment | |
| Normal Vit D | Chronic HCV patients with normal vitamin D level Sustained virological response after treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12
sustained virological response 12 week after treatment
Measured: 12 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study startMar 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HCVStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassan Abdelgawad, Assiut University
- Investigators
- Laila Abd Elbaky, profesor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820102
- Sponsor's protocol ID
- IR,VitD in HCV
- Status last verified
- Feb 2019
- First submitted
- 25 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janovy J Jr. Problems in the comparative physiology of some trypanosomatid flagellates. Acta Trop. 1977 Jun;34(2):177-84.
PubMed 19960Selhub J, Rosenberg IH. Demonstration of high-affinity folate binding activity associated with the brush border membranes of rat kidney. Proc Natl Acad Sci U S A. 1978 Jul;75(7):3090-3. doi: 10.1073/pnas.75.7.3090.
PubMed 28521Ramachandran N, Colman RF. Evidence for a critical glutamyl and an aspartyl residue in the function of pig heart diphosphopyridine nucleotide dependent isocitrate dehydrogenase. Biochemistry. 1977 Apr 19;16(8):1564-73. doi: 10.1021/bi00627a006.
PubMed 15585
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With Hepatitis C Viral Infection Treated by Direct Acting Antiviral Drugs
- ClinicalTrials.gov ID
- NCT03820102
- Acronym / sponsor ID
- IR,VitD in HCV
- Conditions
- HCV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 29 Jan 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.
- Study Changes in lipid profile and the impact of Insulin resistance on virological response in patients with Hepatitis C viral infection treated by Direct Acting Antiviral agents
- The assessment of serum vitamin D levels in HCV infected patients and predictive value of pre-treatment serum vitamin D level for achieving sustained virological response at 12 weeks post-treatment
Detailed description
Patients and methods:
This cross-sectional study will include 100patients of chronic HCV infection who attend El Raghy Assiut university Hospital, either inpatients or outpatients. Chronic HCV infection will be diagnosed based on detectable HCV RNA with anti-HCV Ab in patient with clinical and/or ultrasonographic criteria of chronic liver disease.
Patients will receive treatment to HCV by DAAs and follow up for 12 weeks to confirm sustained virological response
Method:
Patients presenting in this study will be subjected to the following:
- Full history and clinical evaluation.
- Body weight (kg) and height (m).
- BMI will calculate as weight divided by squared height (kg/m2).
- Waist circumference will measured at a level midway between the lowest rib and the iliac crest, and the hip circumference at the level of the great trochanters, with the legs close together.
- Blood pressure (mmHg) was measured twice in the upper arm after a 10-min period of rest and taken an average.
Laboratory investigations will include:
- Complete blood count (CBC)
- Liver function test
- HCV Ab and HCV RNA by PCR
- HBs Ag
- Alpha fetoprotein
- Lipid profile
- Serum urea and creatinine
- Fasting blood sugar (FBG)and Serum fasting insulin level
- Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting insulin (µu/ml) × fasting glucose (mmol/L) ----------------------------------------------------------------- 22.5 An index value of ˃ 2. 5 was defined as IR (Huang et al., 2011)
- Vitamin D level:
Vitamin D deficiency wasdefined as a 25 (OH)-vitamin D serum level < 20 ng/mL, vitaminD insufficiency as 25 (OH)-vitamin D levels of 20 - 29.9ng/mL, and normal vitamin D levels ≥ 30 ng/mL (Holick MF et al.,2011)
- Abdominal Ultrasound
- Electrocardiogram (ECG)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vit D deficiency | – | –Chronic HCV patients with vitamin D deficiency Sustained virological response after treatment |
| Normal Vit D | – | –Chronic HCV patients with normal vitamin D level Sustained virological response after treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. Full history and clinical evaluation. 2. Body weight and height 3. BMI will calculate as weight divided by squared height (kg/m2) 4. Waist circumference 5. Blood pressure (mmHg) Laboratory investigations will include: * Complete blood count (CBC) * Liver function test * HCV Ab and HCV RNA by PCR * HBs Ag * Alpha fetoprotein * Lipid profile * Serum urea and creatinine * Fasting blood sugar and Serum fasting insulin level * Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting insulin (µu/ml) × fasting glucose (mmol/L) 22.5 An index value of ˃ 2. 5 was defined as IR (Huang et al., 2011) * Vitamin D level: * Abdominal Ultrasound * Electrocardiogram
Key inclusion criteria (1 listed)
- Chronic HCV will receive DAAs for treatment
Key exclusion criteria (8 listed)
- Decompensated liver cirrhosis, hepatocellular carcinoma, history of liver transplant
- Co-existing liver disease (hepatitis B virus, autoimmune hepatitis, human immunodeficiency virus)
- Extra-hepatic malignancy except after two years of disease free interval.
- Patients with diabetes mellitus.
- Patients with Chronic kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SVR12
Time frame: 12 week after treatment
sustained virological response 12 week after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Results publication: PubMed 19960Janovy J Jr. Problems in the comparative physiology of some trypanosomatid flagellates. Acta Trop. 1977 Jun;34(2):177-84.
- Results publication: PubMed 28521Selhub J, Rosenberg IH. Demonstration of high-affinity folate binding activity associated with the brush border membranes of rat kidney. Proc Natl Acad Sci U S A. 1978 Jul;75(7):3090-3. doi: 10.1073/pnas.75.7.3090.
- Results publication: PubMed 15585Ramachandran N, Colman RF. Evidence for a critical glutamyl and an aspartyl residue in the function of pig heart diphosphopyridine nucleotide dependent isocitrate dehydrogenase. Biochemistry. 1977 Apr 19;16(8):1564-73. doi: 10.1021/bi00627a006.
- Individual participant dataSharing planned: No
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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.
Laila Abd Elbaky, profesor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of HCV, run by Assiut University.
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 1 inclusion and 8 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed H Abdelgawad, specialist (01008778754, d_m_h_80@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR12 (time frame: 12 week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03820102, which also lists 3 linked publications.
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 5 Feb 2019.