Treatment of Hepatitis c by Using Direct-acting Antiviral

NCT ID: NCT05372874

Last Updated: 2022-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-06

Study Completion Date

2022-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy voluntaries control group (Group 1)

No interventions assigned to this group

sofosbuvir/daclatasvir treated group (group 2)

Direct Acting Antivirals

Intervention Type DRUG

hepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks.

sofosbuvir /daclatasvir/ ribavirin treated group (group 3)

Direct Acting Antivirals

Intervention Type DRUG

hepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Direct Acting Antivirals

hepatitis C patients will be treated by direct acting antiviral drugs (DAAs)for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Heba Mohammed Hashem Ali

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sabry A AbouSaif, Professor

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Sally E Abu-Risha, Associate professor

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Medhat I Abd-El Hamed, Professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Al-Azhar University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Heba M Hashem, Assistant lecturer

Role: CONTACT

0201010636236

Nageh A El-Mahdy, Professor

Role: CONTACT

0201095115033

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Hepatitis C

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pharmacist-led Hepatitis C Management
NCT04322981 UNKNOWN PHASE4
Hepatitis C Self-Management
NCT00328042 COMPLETED NA