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Treatment of Hepatitis c by Using Direct-acting Antiviral

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05372874
Collaborator
(none)
50
Enrollment
2.8
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Direct Acting Antivirals

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of the Effect of Direct-Acting Antiviral Agents on Melatonin Level in Chronic Hepatitis C Patients in Egypt.
Anticipated Study Start Date :
May 6, 2022
Anticipated Primary Completion Date :
Jul 12, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Change in malondialdehyde (MDA) level. [12 weeks following end of treatment.]

    Malondialdehyde (MDA) levels will be measured by the TBARS assay (thiobarbituric acid reactive substance assay)

  2. Change in melatonin level. [12 weeks following end of treatment.]

    Melatonin will be measured by using immunological method.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heba Mohammed Hashem Ali, Assistant lecturer, Tanta University
ClinicalTrials.gov Identifier:
NCT05372874
Other Study ID Numbers:
  • Hepatitis C
First Posted:
May 13, 2022
Last Update Posted:
May 13, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis
Antiviral Agents

Study Results

No Results Posted as of May 13, 2022