- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03402165
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
-
-
-
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
|
Response to DAAD's and developing HCC
Other Names:
|
EXPERIMENTAL: Mild elevation of alfafetoprotein
Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
|
Response to DAAD's and developing HCC
Other Names:
|
EXPERIMENTAL: High elevation of alfafetoprotein
Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
|
Response to DAAD's and developing HCC
Other Names:
|
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
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
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
- Ledipasvir, sofosbuvir drug combination
- Ledipasvir
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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