Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients With Chronic Hepatitis C

August 23, 2018 updated by: Sherief Abd-Elsalam

Impact of Serum Alpha-fetoprotein Levels on the Response to Direct Antiviral Therapy in Egyptian Patients With Chronic Hepatitis C

Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Patients with Chronic Hepatitis C

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Impact of Serum Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Egyptian Patients with Chronic Hepatitis C

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HCV patients who will undergo treatment by direct acting antiviral agents.

Exclusion Criteria:

  • Patients with decompensated liver disease

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Normal Alfafetoprotein
Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Response to DAAD's and developing HCC
Other Names:
  • Sofaldy, Harvony
EXPERIMENTAL: Mild elevation of alfafetoprotein
Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Response to DAAD's and developing HCC
Other Names:
  • Sofaldy, Harvony
EXPERIMENTAL: High elevation of alfafetoprotein
Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Response to DAAD's and developing HCC
Other Names:
  • Sofaldy, Harvony

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with sustained virologic response
Time Frame: 6 months
The total number of patients with SVR in each group
6 months

Collaborators and Investigators

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

Sponsor

Sherief Abd-Elsalam

Investigators

  • Principal Investigator: Rehab Badawi, MD, Tanta University
  • Study Director: Mohamed Alboraie, MD, AlAzhar university
  • Study Director: Mohamed el kassas, MD, Helwan 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 (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (ACTUAL)

January 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alfafetoprotein

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

No

Studies a U.S. FDA-regulated device product

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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