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

Primary Purpose

Hepatitis C

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Patients with decompensated liver disease

Sites / Locations

Sherief Abd-ElsalamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Normal Alfafetoprotein

Mild elevation of alfafetoprotein

High elevation of alfafetoprotein

Arm Description

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Outcomes

Primary Outcome Measures

Number of patients with sustained virologic response

The total number of patients with SVR in each group

Secondary Outcome Measures

Full Information

NCT ID

NCT03402165

First Posted

January 9, 2018

Last Updated

August 23, 2018

Sponsor

Sherief Abd-Elsalam

1. Study Identification

Unique Protocol Identification Number

NCT03402165

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sherief Abd-Elsalam

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Normal Alfafetoprotein

Arm Type

Experimental

Arm Description

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Arm Title

Mild elevation of alfafetoprotein

Arm Type

Experimental

Arm Description

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Arm Title

High elevation of alfafetoprotein

Arm Type

Experimental

Arm Description

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Other Intervention Name(s)

Sofaldy, Harvony

Intervention Description

Response to DAAD's and developing HCC

Primary Outcome Measure Information:

Title

Number of patients with sustained virologic response

Description

The total number of patients with SVR in each group

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HCV patients who will undergo treatment by direct acting antiviral agents. Exclusion Criteria: Patients with decompensated liver disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sherief Abd-Elsalam, md

Phone

00201095159522

sheriefabdelsalam@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rehab Badawi, MD

Organizational Affiliation

Tanta University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohamed Alboraie, MD

Organizational Affiliation

ALAZHAR UNIVERSITY

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sherief Abd-Elsalam, MD

Organizational Affiliation

Tanta University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mohamed el kassas, MD

Organizational Affiliation

Helwan University

Official's Role

Study Director

Facility Information:

Facility Name

Sherief Abd-Elsalam

City

Tanta

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherief Abd-elsalam, lecturer

Phone

00201000040794

Sherif_tropical@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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