Treatment of Hepatitis c by Using Direct-acting Antiviral
Evaluation of the Effect of Direct-Acting Antiviral Agents on Melatonin Level in Chronic Hepatitis C Patients in Egypt.
1 other identifier
observational
50
0 countries
N/A
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2022
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2022
CompletedFirst Submitted
Initial submission to the registry
May 9, 2022
CompletedFirst Posted
Study publicly available on registry
May 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedMay 13, 2022
May 1, 2022
2 months
May 9, 2022
May 9, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Change in malondialdehyde (MDA) level.
Malondialdehyde (MDA) levels will be measured by the TBARS assay (thiobarbituric acid reactive substance assay)
12 weeks following end of treatment.
Change in melatonin level.
Melatonin will be measured by using immunological method.
12 weeks following end of treatment.
Study Arms (3)
Healthy voluntaries control group (Group 1)
sofosbuvir/daclatasvir treated group (group 2)
sofosbuvir /daclatasvir/ ribavirin treated group (group 3)
Interventions
hepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks.
Eligibility Criteria
Hepatitis C patients treated by daclatasvir/sofosbuvir or sofosbuvir /daclatasvir/ ribavirin.
You may qualify if:
- chronic hepatitis C patients had no other cause of liver disease
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabry A AbouSaif, Professor
Tanta University
- PRINCIPAL INVESTIGATOR
Sally E Abu-Risha, Associate professor
Tanta University
- PRINCIPAL INVESTIGATOR
Medhat I Abd-El Hamed, Professor
Faculty of Medicine, Al-Azhar University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
May 9, 2022
First Posted
May 13, 2022
Study Start
May 6, 2022
Primary Completion
July 12, 2022
Study Completion
July 30, 2022
Last Updated
May 13, 2022
Record last verified: 2022-05