NCT03402165

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 9, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

5.9 years

First QC Date

January 9, 2018

Last Update Submit

August 23, 2018

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Number of patients with sustained virologic response

    The total number of patients with SVR in each group

    6 months

Study Arms (3)

Normal Alfafetoprotein

EXPERIMENTAL

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Mild elevation of alfafetoprotein

EXPERIMENTAL

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

High elevation of alfafetoprotein

EXPERIMENTAL

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Interventions

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvirDRUG

Response to DAAD's and developing HCC

Also known as: Sofaldy, Harvony
High elevation of alfafetoproteinMild elevation of alfafetoproteinNormal Alfafetoprotein

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with decompensated liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvirledipasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Rehab Badawi, MD

    Tanta University

    PRINCIPAL INVESTIGATOR

  • Mohamed Alboraie, MD

    Al-Azhar University

    STUDY DIRECTOR

  • Sherief Abd-Elsalam, MD

    Tanta University

    STUDY DIRECTOR

  • Mohamed el kassas, MD

    Helwan University

    STUDY DIRECTOR

Central Study Contacts

Sherief Abd-Elsalam, md

CONTACT

00201095159522sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhDTropical Medicine

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 18, 2018

Study Start

January 1, 2017

Primary Completion

December 1, 2022

Study Completion

December 30, 2022

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations

EG(1)