Hepatitis cNCT03591783
Impact of Sustained Virologic Response on Glycemic Control Among Diabetic Patients With Hepatitis C Virus Related Liver Disease
An observational study of Hepatitis c, run by Assiut University.
Trial summary
Hepatitis C virus (HCV) is a major cause of chronic liver disease. The World Health Organization has reported that 170 million people are chronically infected with HCV globally. The highest prevalence of HCV infection worldwide exists in Egypt (15%); 90% of infection among Egyptian patients is due to genotype 4 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis c
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with chronic HCV infection with type 2 DM, who are eligible for antiviral therapy.
Who may be able to join
- Chronic HCV infection will be diagnosed based on positive testing for serum HCV RNA and anti-HCV Ab.
- Diagnosis of type 2 DM will depend on fasting level of serum glucose more than 126 mg/dl and/or serum level of HbA1c more than 6.5 % on oral hypoglycemic therapy.
Who cannot join
- Chronic hepatitis due to causes other than HCV infection
- Coinfection with HBV infection
- Hepatocellular carcinoma
- Child C stage of liver cirrhosis.
- Patients with type I diabetes mellitus.
- Cardiopulmonary diseases.
Show all 9Show fewer
- Major illness.
- Patient receiving corticosteroids.
- Patient refused consent.
About this study
Hepatitis C virus (HCV) is a major cause of chronic liver disease. The World Health Organization has reported that 170 million people are chronically infected with HCV globally. The highest prevalence of HCV infection worldwide exists in Egypt (15%); 90% of infection among Egyptian patients is due to genotype 4
- Conditions
- Hepatitis c
- Medical subject headings
- Hepatitis C
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 |
|---|---|---|
| study group | All patients will be subjected to: Baseline investigations, end of treatment investigations and 3 months after treatment investigations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients with glycemic control
Exploring the impact of achieving SVR by directly acting antiviral drugs on glycemic control among diabetic patients with HCV infection.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study startAug 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis cStudies 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
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Judy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591783
- Sponsor's protocol ID
- HCVDM
- Status last verified
- Jul 2018
- First submitted
- 9 Jul 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sustained Virologic Response on Glycemic Control Among Diabetic Patients With Hepatitis C Virus Related Liver Disease
- ClinicalTrials.gov ID
- NCT03591783
- Acronym / sponsor ID
- HCVDM
- Conditions
- Hepatitis c
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Jul 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.
Hepatitis C virus (HCV) is a major cause of chronic liver disease. The World Health Organization has reported that 170 million people are chronically infected with HCV globally. The highest prevalence of HCV infection worldwide exists in Egypt (15%); 90% of infection among Egyptian patients is due to genotype 4
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –All patients will be subjected to: Baseline investigations, end of treatment investigations and 3 months after treatment investigations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with chronic HCV infection with type 2 DM, who are eligible for antiviral therapy.
Key inclusion criteria (2 listed)
- Chronic HCV infection will be diagnosed based on positive testing for serum HCV RNA and anti-HCV Ab.
- Diagnosis of type 2 DM will depend on fasting level of serum glucose more than 126 mg/dl and/or serum level of HbA1c more than 6.5 % on oral hypoglycemic therapy.
Key exclusion criteria (9 listed)
- Chronic hepatitis due to causes other than HCV infection
- Coinfection with HBV infection
- Hepatocellular carcinoma
- Child C stage of liver cirrhosis.
- Patients with type I diabetes mellitus.
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
the percentage of patients with glycemic control
Time frame: 3 months
Exploring the impact of achieving SVR by directly acting antiviral drugs on glycemic control among diabetic patients with HCV infection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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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 Hepatitis c, 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 2 inclusion and 9 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 19 Jul 2018. 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?
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?
the percentage of patients with glycemic control (time frame: 3 months). 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 19 Jul 2018.