Treatment of Hepatitis c by Using Direct-acting Antiviral

May 9, 2022 updated by: Heba Mohammed Hashem Ali, Tanta University

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hepatitis C patients treated by daclatasvir/sofosbuvir or sofosbuvir /daclatasvir/ ribavirin.

Description

Inclusion Criteria:

  • chronic hepatitis C patients had no other cause of liver disease

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy voluntaries control group (Group 1)
sofosbuvir/daclatasvir treated group (group 2)
Drug: Direct Acting Antivirals
hepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks.
sofosbuvir /daclatasvir/ ribavirin treated group (group 3)
Drug: Direct Acting Antivirals
hepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks following end of treatment.
Change in melatonin level.
Time Frame: 12 weeks following end of treatment.
Melatonin will be measured by using immunological method.
12 weeks following end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Sabry A AbouSaif, Professor, Faculty of medicine, Tanta University
  • Principal Investigator: Sally E Abu-Risha, Associate professor, Faculty of Pharmacy, Tanta University
  • Principal Investigator: Medhat I Abd-El Hamed, Professor, Faculty of Medicine, Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 6, 2022

Primary Completion (ANTICIPATED)

July 12, 2022

Study Completion (ANTICIPATED)

July 30, 2022

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 9, 2022

First Posted (ACTUAL)

May 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hepatitis C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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