Hepatitis CNCT05372874
Treatment of Hepatitis c by Using Direct-acting Antiviral
An observational study of Hepatitis C, run by Tanta University.
Trial summary
Patients with hepatitis c showed increased level of oxidative stress. Increased level of serum lipid peroxidation leads to the production of toxic mediators as malondialdehyde (MDA) which lead to disease progression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Direct Acting Antivirals
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2022to 30 Jul 2022
- 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
- Adult, Older adult
Study population: Hepatitis C patients treated by daclatasvir/sofosbuvir or sofosbuvir /daclatasvir/ ribavirin.
Who may be able to join
- chronic hepatitis C patients had no other cause of liver disease
Who cannot join
- Patients with hepatitis B virus (HBV).
- Patients with acute hepatitis.
- Patients with renal insufficiency.
- Patients with Hepatocellular carcinoma (HCC) or other types of malignancy.
- Patients on current use of melatonin.
- Patients using of any of medications that have interaction with melatonin.
- Patients work in night shifts.
- Patients are consuming a lot of caffeine or heavy smokers.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effect of Direct-Acting Antiviral Agents on Melatonin Level in Chronic Hepatitis C Patients in Egypt.
Patients with hepatitis c showed increased level of oxidative stress. Increased level of serum lipid peroxidation leads to the production of toxic mediators as malondialdehyde (MDA) which lead to disease progression. Chronic stress shunt tryptophan which is essential amino acid toward kynurenic pathway leading to lower level of serotonin and melatonin level. Currently, direct-acting antivirals (DAAs) show well-established efficacy against hepatitis C virus (HCV).
- Conditions
- Hepatitis C
- Being tested
- Direct Acting Antivirals
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Acting AntiviralsDrug
hepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Healthy voluntaries control group (Group 1) | Not described | |
| sofosbuvir/daclatasvir treated group (group 2) | Not described Receives: Drug: Direct Acting Antivirals | |
| sofosbuvir /daclatasvir/ ribavirin treated group (group 3) | Not described Receives: Drug: Direct Acting Antivirals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in malondialdehyde (MDA) level.
Malondialdehyde (MDA) levels will be measured by the TBARS assay (thiobarbituric acid reactive substance assay)
Measured: 12 weeks following end of treatment.
Change in melatonin level.
Melatonin will be measured by using immunological method.
Measured: 12 weeks following end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start6 May 2022 (estimated)
- Primary completion12 Jul 2022 (estimated)
- Study completion30 Jul 2022 (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 Tanta 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohammed Hashem Ali, Tanta University
- Investigators
- Sabry A AbouSaif, Professor, Principal investigator, Tanta UniversitySally E Abu-Risha, Associate professor, Principal investigator, Tanta UniversityMedhat I Abd-El Hamed, Professor, Principal investigator, Faculty of Medicine, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372874
- Sponsor's protocol ID
- Hepatitis C
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Direct-Acting Antiviral Agents on Melatonin Level in Chronic Hepatitis C Patients in Egypt.
- ClinicalTrials.gov ID
- NCT05372874
- Acronym / sponsor ID
- Hepatitis C
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 6 May 2022 (estimated)
- Primary completion
- 12 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 13 May 2022 (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.
Patients with hepatitis c showed increased level of oxidative stress. Increased level of serum lipid peroxidation leads to the production of toxic mediators as malondialdehyde (MDA) which lead to disease progression. Chronic stress shunt tryptophan which is essential amino acid toward kynurenic pathway leading to lower level of serotonin and melatonin level. Currently, direct-acting antivirals (DAAs) show well-established efficacy against hepatitis C virus (HCV).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy voluntaries control group (Group 1) | – | – |
| sofosbuvir/daclatasvir treated group (group 2) | – | Drug: Direct Acting Antivirals |
| sofosbuvir /daclatasvir/ ribavirin treated group (group 3) | – | Drug: Direct Acting Antivirals |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hepatitis C patients treated by daclatasvir/sofosbuvir or sofosbuvir /daclatasvir/ ribavirin.
Key inclusion criteria (1 listed)
- chronic hepatitis C patients had no other cause of liver disease
Key exclusion criteria (8 listed)
- Patients with hepatitis B virus (HBV).
- Patients with acute hepatitis.
- Patients with renal insufficiency.
- Patients with Hepatocellular carcinoma (HCC) or other types of malignancy.
- Patients on current use of melatonin.
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 |
|---|---|---|
| Direct Acting Antiviralshepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks. | Drug | sofosbuvir /daclatasvir/ ribavirin treated group (group 3), sofosbuvir/daclatasvir treated group (group 2) |
Primary outcome
Change in malondialdehyde (MDA) level.
Time frame: 12 weeks following end of treatment.
Malondialdehyde (MDA) levels will be measured by the TBARS assay (thiobarbituric acid reactive substance assay)
Change in melatonin level.
Time frame: 12 weeks following end of treatment.
Melatonin will be measured by using immunological method.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Sabry A AbouSaif, Professor principal investigator
Tanta University
Sally E Abu-Risha, Associate professor principal investigator
Tanta University
Medhat I Abd-El Hamed, Professor principal investigator
Faculty of Medicine, Al-Azhar University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Tanta 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 13 May 2022. 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 Heba M Hashem, Assistant lecturer (0201010636236, heba.hashem@su.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in malondialdehyde (MDA) level. (time frame: 12 weeks following end of treatment.). The study lists 2 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 13 May 2022.