Treatment of Hepatitis c by Using Direct-acting Antiviral

Hepatitis C Clinical Trial

Official title:

Evaluation of the Effect of Direct-Acting Antiviral Agents on Melatonin Level in Chronic Hepatitis C Patients in Egypt.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05372874
• Other study ID #: Hepatitis C
• Status: Not yet recruiting
• Start date: May 6, 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: May 2022
• Source: Tanta University
• Contact: Heba M Hashem, Assistant lecturer
• Phone: 0201010636236
• Email: heba.hashem[@]su.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 30, 2022
• Est. primary completion date: July 12, 2022
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Direct Acting Antivirals
hepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Change in melatonin level.	Melatonin will be measured by using immunological method.	12 weeks following end of treatment.