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

Sherief Abd-Elsalam

Status and phase: Unknown; Phase 4

Conditions: Hepatitis C

Treatments: Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Study type: Interventional

Funder types: Other

Identifiers

NCT03402165

Alfafetoprotein

Details and patient eligibility

About

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

Full description

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

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients with decompensated liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 3 patient groups

Normal Alfafetoprotein

Experimental group

Description:

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Treatment:

Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Mild elevation of alfafetoprotein

Experimental group

Description:

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Treatment:

Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

High elevation of alfafetoprotein

Experimental group

Description:

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Treatment:

Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir