Back to resultsThe Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia
Primary Purpose
Hepatitis C
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sofosbuvir daclatasvir
Ledipasvir/sofosbuvir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- Hepatitis C virus infection and thrombocytopenia before treatment
Exclusion Criteria:
- Infection Hepatitis B virus
- Hypersplenism
- Diseases affecting Bone marrow
- Major clotting factors abnormalities eg. Disseminated intravascular coagulopathy, severe Prothrombin deficiency
Sites / Locations
- Assiut UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study group
Arm Description
Hepatitis- C virus with thrombocytopenia
Outcomes
Primary Outcome Measures
the mean difference on the platelet count
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03169348
Brief Title
The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia
Official Title
The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Autoimmune thrombocytopenic purpura is an immunological disorder characterized by increased platelet destruction due to presence of anti-platelet antibodies. Hepatitis C virus infection, which is one of the most common chronic viral infections worldwide, may cause secondary chronic immune thrombocytopenic purpura. It seemed to play a pathogenic role in autoimmune thrombocytopenic purpura. Moreover, the successful response (negative hepatitis C virus - ribonucleic acid) to tapered steroids and antiviral therapy was useful to revert thrombocytopenia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
Hepatitis- C virus with thrombocytopenia
Intervention Type
Drug
Intervention Name(s)
sofosbuvir daclatasvir
Intervention Description
oral tablets
Intervention Type
Drug
Intervention Name(s)
Ledipasvir/sofosbuvir
Intervention Description
oral tablets
Primary Outcome Measure Information:
Title
the mean difference on the platelet count
Time Frame
6 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hepatitis C virus infection and thrombocytopenia before treatment
Exclusion Criteria:
Infection Hepatitis B virus
Hypersplenism
Diseases affecting Bone marrow
Major clotting factors abnormalities eg. Disseminated intravascular coagulopathy, severe Prothrombin deficiency
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abbas, MD
Phone
00201003385183
Email
bmr90@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia
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