Chronic Hepatitis CNCT02788682
Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy
An observational study of Chronic Hepatitis C, run by Cairo University.
Trial summary
Introduction: Vitamin D binding protein (VDBP) is a potential modulator of immune response and is associated with clinical progression of many diseases. Our aim is to assess influence of baseline 25-hydroxyvitamin D levels and VDBP single nucleotide polymorphisms (SNPs), rs4588 (C>A) and rs7041 (G>T), on baseline… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- WT+ Diplotype
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jul 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Hepatitis C patients in Egypt
Who may be able to join
- Age ≥ 18 years and ≤ 60 years, fasting blood sugar less than 115 mg/dl or 20% upper normal limit (140 mg/dl), HBA1C ≤ 7.5% in diabetic patients, normal serum creatinine, normal thyroid stimulating hormone level, negative Hepatitis B surface antigen, hemoglobin ≥ 12g/dl for male or ≥ 11g/dl for female, total leukocytes ≥ 3,500/mm3, ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, presence of HCV RNA by PCR and elevated liver enzymes within the preceding 6 months for patients with F1 fibrosis stage.
Who cannot join
- hypersensitivity to interferon or ribavirin, decompensated liver cirrhosis (presence of ascites, esophageal varices or hepatic encephalopathy), hepatocellular carcinoma, body mass index>35 Kg/m2 and vitamin D supplementation.
About this study
Official title: Association of Vitamin D Binding Protein Polymorphisms With Response to Therapy in Chronic Hepatitis C Egyptian Patients
Introduction: Vitamin D binding protein (VDBP) is a potential modulator of immune response and is associated with clinical progression of many diseases. Our aim is to assess influence of baseline 25-hydroxyvitamin D levels and VDBP single nucleotide polymorphisms (SNPs), rs4588 (C>A) and rs7041 (G>T), on baseline clinical parameters and response to interferon based therapy in chronic Hepatitis C patients in Egypt.
Methodology: Genotyping will be performed by RFLP (Restriction Fragment Length Polymorphism) in treatment naïve Hepatitis C patients and healthy controls. Vitamin D levels will be assessed by ELISA. HCV RNA quantification will be performed by PCR to assess therapy outcome.
- Conditions
- Chronic Hepatitis C
- Being tested
- WT+ Diplotype
- Keywords
- VDBP, single nucleotide polymorphisms (SNPs), interferon based therapy, Egypt
- 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.
WT+ DiplotypeGenetic
3 or 4 vitamin D binding protein major alleles
| Study group | Role | What they receive |
|---|---|---|
| Patients | WT+ Diplotype Receives: Genetic: WT+ Diplotype | |
| Controls | WT- Diplotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startSep 2013
- Primary completionJul 2015
- Study completionJul 2015
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 Cairo 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
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Sayed Kamel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788682
- Sponsor's protocol ID
- CL (770)
- Status last verified
- Jul 2016
- First submitted
- 27 May 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Vitamin D Binding Protein Polymorphisms With Response to Therapy in Chronic Hepatitis C Egyptian Patients
- ClinicalTrials.gov ID
- NCT02788682
- Acronym / sponsor ID
- CL (770)
- Conditions
- Chronic Hepatitis C
- Keywords
- VDBP, single nucleotide polymorphisms (SNPs), interferon based therapy, Egypt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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.
Introduction: Vitamin D binding protein (VDBP) is a potential modulator of immune response and is associated with clinical progression of many diseases. Our aim is to assess influence of baseline 25-hydroxyvitamin D levels and VDBP single nucleotide polymorphisms (SNPs), rs4588 (C>A) and rs7041 (G>T), on baseline clinical parameters and response to interferon based therapy in chronic Hepatitis C patients in Egypt.
Methodology: Genotyping will be performed by RFLP (Restriction Fragment Length Polymorphism) in treatment naïve Hepatitis C patients and healthy controls. Vitamin D levels will be assessed by ELISA. HCV RNA quantification will be performed by PCR to assess therapy outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Genetic: WT+ DiplotypeWT+ Diplotype |
| Controls | – | –WT- Diplotype |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Hepatitis C patients in Egypt
Key inclusion criteria (1 listed)
- Age ≥ 18 years and ≤ 60 years, fasting blood sugar less than 115 mg/dl or 20% upper normal limit (140 mg/dl), HBA1C ≤ 7.5% in diabetic patients, normal serum creatinine, normal thyroid stimulating hormone level, negative Hepatitis B surface antigen, hemoglobin ≥ 12g/dl for male or ≥ 11g/dl for female, total leukocytes ≥ 3,500/mm3, ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, presence of HCV RNA by PCR and elevated liver enzymes within the preceding 6 months for patients with F1 fibrosis stage.
Key exclusion criteria (1 listed)
- hypersensitivity to interferon or ribavirin, decompensated liver cirrhosis (presence of ascites, esophageal varices or hepatic encephalopathy), hepatocellular carcinoma, body mass index>35 Kg/m2 and vitamin D supplementation.
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 |
|---|---|---|
| WT+ Diplotype3 or 4 vitamin D binding protein major alleles | Genetic | Patients |
Primary outcome
SVR
Time frame: 72 weeks
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 26 Jul 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by Cairo 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 1 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 26 Jul 2016. 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?
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 (time frame: 72 weeks). 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 26 Jul 2016.