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

Phase 4

• Conditions: Hepatitis C
• Interventions: Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

• Registration Number: NCT03402165
• Lead Sponsor: Sherief Abd-Elsalam

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

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-18
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-27
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

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

Exclusion Criteria

• Patients with decompensated liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild elevation of alfafetoprotein	Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir	Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Normal Alfafetoprotein	Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir	Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
High elevation of alfafetoprotein	Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir	Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Primary Outcome Measures

Name	Time	Method
Number of patients with sustained virologic response	6 months	The total number of patients with SVR in each group

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Tanta, Egypt