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Trial record 86 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

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

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ClinicalTrials.gov Identifier: NCT03402165
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Serum Alpha-fetoprotein Levels on the Response to Direct Antiviral Therapy in Egyptian Patients With Chronic Hepatitis C
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Normal Alfafetoprotein
Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Response to DAAD's and developing HCC
Other Name: Sofaldy, Harvony

Experimental: Mild elevation of alfafetoprotein
Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Response to DAAD's and developing HCC
Other Name: Sofaldy, Harvony

Experimental: High elevation of alfafetoprotein
Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Response to DAAD's and developing HCC
Other Name: Sofaldy, Harvony




Primary Outcome Measures :
  1. Number of patients with sustained virologic response [ Time Frame: 6 months ]
    The total number of patients with SVR in each group



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with decompensated liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402165


Contacts
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Contact: Sherief Abd-Elsalam, md 00201095159522 sheriefabdelsalam@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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Principal Investigator: Rehab Badawi, MD Tanta University
Study Director: Mohamed Alboraie, MD Alazhar University
Study Director: Sherief Abd-Elsalam, MD Tanta University
Study Director: Mohamed el kassas, MD Helwan University

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Responsible Party: Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT03402165     History of Changes
Other Study ID Numbers: Alfafetoprotein
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Hepatitis, Chronic
Antiviral Agents
Sofosbuvir
Anti-Infective Agents