Back to resultsEarly Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs
Primary Purpose
Liver Transplantation
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
treatment of HCV with oral direct acting antiviral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Liver Transplantation
Eligibility Criteria
Inclusion Criteria:
- All transplanted patients for HCV related disease in the period from 2014 to 2016
Exclusion Criteria:
- Patients transplanted for other causes rather than HCv
- Patients with HBV and HCV co infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1: treatment after 6 months post transplantation
Group 2: early treatment afer 3 months post transplantation
Arm Description
53 patients received Sofosbuvir+ribavirin standard of care for treatment of HCV post liver transplantation for 6 months
36 patients received other DAAs regiment for treatment of HCV post liver transplantation for 3- 6 months
Outcomes
Primary Outcome Measures
Virologic response at 12 weeks after completion of therapy
Assessment of virologic response after 3 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03133065
Brief Title
Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs
Official Title
Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study aimed to present our experience in treating recurrent HCV genotype 4 infection post living donor liver transplantation (LDLT) since introduction of the second generation direct acting antiviral drugs (DAAs) in Egypt.
Detailed Description
This was a cohort study conducted in patients who had undergone LDLT for HCV related disease from 2014 to 2016 at in Ain Shams Center for Organ Transplantation (ASCOT) .The hypothesis early initiation of DAAs( after 12 weeks of the operation ) is effective and safe strategy in transplant recipients following LDLT. Patients who take the sofosbuvir and ribavirin after 6 months after transplantation were compared with those who take early treatment after 3 months of transplantation with sofosbuvir and daclatsvir+/- ribavirin..Patients were on regular follow up visits monthly to assess the clinical condition, any side effects, laboratory tests including complete blood picture, liver functions , renal functions and trough level of immunosuppressant drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: treatment after 6 months post transplantation
Arm Type
Active Comparator
Arm Description
53 patients received Sofosbuvir+ribavirin standard of care for treatment of HCV post liver transplantation for 6 months
Arm Title
Group 2: early treatment afer 3 months post transplantation
Arm Type
Active Comparator
Arm Description
36 patients received other DAAs regiment for treatment of HCV post liver transplantation for 3- 6 months
Intervention Type
Drug
Intervention Name(s)
treatment of HCV with oral direct acting antiviral therapy
Intervention Description
A total number of 89 patients transplanted for HCV genotype 4 related end stage liver disease Were included in this study 53 PATIENTS were treated after 6 months of transplantation with sofosbuvir 400mg and weight based ribavirin for 24 weeks. 7 patients were treated with sofosbuvir 400mg + simeprevir 150 mg + weight based ribavirin for 12 weeks after 6 months post transplant. In September 2015, we started to adopt early treatment strategy for all recipients after the first 3months post- transplant. 26 recipients were treated with sofosbuvir 400mg+Daclatasvir 60mg ± weight based ribavirin for 12 weeks or 24 weeks. 2 recipient are treated with sofosbuvir 400mg + ledipasvir 90mg for 24 weeks and one recipient is treated with fixed-dose combination of ombitasvir (12.5 mg), paritaprevir (75 mg) and ritonavir (50 mg) + weight based ribavirin due to having persistent renal impairment post transplantation.
Primary Outcome Measure Information:
Title
Virologic response at 12 weeks after completion of therapy
Description
Assessment of virologic response after 3 months
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All transplanted patients for HCV related disease in the period from 2014 to 2016
Exclusion Criteria:
Patients transplanted for other causes rather than HCv
Patients with HBV and HCV co infection
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs
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