Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 9, 2018
First Posted Date  ICMJE January 18, 2018
Last Update Posted Date August 27, 2018
Actual Study Start Date  ICMJE January 1, 2017
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
Number of patients with sustained virologic response [ Time Frame: 6 months ]
The total number of patients with SVR in each group
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03402165 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients With Chronic Hepatitis C
Official Title  ICMJE Impact of Serum Alpha-fetoprotein Levels on the Response to Direct Antiviral Therapy in Egyptian Patients With Chronic Hepatitis C
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Response to DAAD's and developing HCC
Other Name: Sofaldy, Harvony
Study Arms  ICMJE
  • Experimental: Normal Alfafetoprotein
    Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
    Intervention: Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
  • Experimental: Mild elevation of alfafetoprotein
    Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
    Intervention: Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
  • Experimental: High elevation of alfafetoprotein
    Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
    Intervention: Drug: Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2018)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with decompensated liver disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sherief Abd-Elsalam, md 00201095159522 sheriefabdelsalam@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03402165
Other Study ID Numbers  ICMJE Alfafetoprotein
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sherief Abd-Elsalam, Tanta University
Study Sponsor  ICMJE Sherief Abd-Elsalam
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Tanta University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP