Liver TransplantationNCT03665766
Effect of Cyclosporine A Versus Tacrolimus on Response to Antiviral Therapy After Hepatitis C Genotype -4 Recurrence Post Liver Transplantation
An observational study of Liver Transplantation, run by Ain Shams University.
Trial summary
Background and Aim: The immunosuppression influence on the response to antiviral therapy (AVT) for recurrent hepatitis C virus (HCV) infection in liver transplant (LT) recipients remains controversial, especially for the rarely investigated genotype 4.This study aims to compare the effects of the two widely used… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Cycloserine,Tacrolimus
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2014to 2 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: living donor liver transplant (LDLT) recipients with recurrent HCV infection, participants were categorized to three groups according to AVT. Group one received pegylated interferon (Peg IFN-α 2a) and ribavirin (RBV) , group two received the direct antiviral agent (DAA) sofosbuvir plus RBV and group three received daclatasvir, sofosbuvir (other DAAs) plus RBV each group was further subdivided according to primary immunosuppression (CsA or Tac)
Who may be able to join
None listed.
Who cannot join
- if they were younger than 18 years or older than 65 years or had one of the following criteria
- alcoholic
- poorly controlled autoimmune disease
- significant cardiac disease
- suicidal ideation
- a history of suicide attempt
Show all 21Show fewer
- major psychosis
- serum creatinine ˃3 mg/dl
- thyroid dysfunction
- combined kidney-liver transplantation
- were currently pregnant or planning pregnancy.
- Group II and III:
- younger than 18 years or older than 75 years
- total bilirubin (T.Bil) >3 mg/dl
- serum albumin< 2.8 mg/dl
- international normalized ratio ≥1.7
- Platelet count < 5000/mm3
- HCC, except 4 weeks after intervention with no evidence of activity using computed tomography or magnetic resonance imaging
- extra hepatic malignancy except after two years of disease free-interval
- uncontrolled diabetes evidenced by glycated haemoglobin >9%
- were pregnant .
About this study
Official title: The Effect of Cyclosporine A Versus Tacrolimus on the Response to Antiviral Treatment After HCV Genotype -4 Recurrence in Recipients of Living Donor Liver Transplantation
Background and Aim: The immunosuppression influence on the response to antiviral therapy (AVT) for recurrent hepatitis C virus (HCV) infection in liver transplant (LT) recipients remains controversial, especially for the rarely investigated genotype 4.This study aims to compare the effects of the two widely used calcineurin inhibitors(CNIs)(Cyclosporine A (CsA) and tacrolimus (Tac)) on the therapeutic response to different AVT regimens. Method: In126 living donor liver transplant (LDLT) recipients with recurrent HCV infection, participants were categorized to three groups according to AVT. Group one received pegylated interferon (Peg IFN-α 2a) and ribavirin (RBV) (n= 44), group two received the direct antiviral agent (DAA) sofosbuvir plus RBV (n=52) and group three received daclatasvir, sofosbuvir (other DAAs) plus RBV(n=30) each group was further subdivided according to primary immunosuppression (CsA or Tac). The sustained virological response (SVR) and relapse rates were considered the primary therapeutic outcomes of AVT. The virological response guided therapy end points for AVT were considered the secondary outcomes.
- Conditions
- Liver Transplantation
- Being tested
- Cycloserine,Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycloserine,TacrolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| IFN group received Cyclosporine | Living donor liver transplantation recipients with recurrent HCV received Peg IFN-α 2a and RBV as antiviral therapy and Cyclosporine A as primary immunosuppression ,this was routinely taken not as intervention according to local practice Receives: Drug: Cycloserine,Tacrolimus | |
| IFN group received tacrolimus | Living donor liver transplantation recipients with recurrent HCV received Peg IFN-α 2a and RBV as antiviral therapy and Tacrolimus as primary immunosuppression ,this was routinely taken not as interventing according to local practice Receives: Drug: Cycloserine,Tacrolimus | |
| Sof plus Rbv group received Cyclosporine | Living donor liver transplantation recipients with recurrent HCV received sofosbuvir and RBV as antiviral therapy and Cyclosporine as primary immunosuppression,this was routinely taken not as intervention according to local practice Receives: Drug: Cycloserine,Tacrolimus | |
| Sof plus Rbv received tacrolimus | Living donor liver transplantation recipients with recurrent HCV received sofosbuvir and RBV as antiviral therapy and Tacrolimus as primary immunosuppression,this was routinely taken not as intervention according to local practice Receives: Drug: Cycloserine,Tacrolimus | |
| Sof,dac pus ribavirin received cyclosporine | Living donor liver transplantation recipients with recurrent HCV received daclatasvir, sofosbuvir and RBV as antiviral therapy and Cyclosporine as primary immunosuppression,this was routinely taken not as intervention according to local practice Receives: Drug: Cycloserine,Tacrolimus | |
| sof,dac plus rbv received tacrolimus | Living donor liver transplantation recipients with recurrent HCV received daclatasvir, sofosbuvir and RBV as antiviral therapy and Tacrolimus as primary immunosuppression,this was routinely taken not as intervention according to local practice Receives: Drug: Cycloserine,Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained virological response
a negative serum HCV RNA
Measured: 24 weeks for group I and 12 weeks for group II and III
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start15 May 2014
- Primary completion2 Apr 2018
- Study completion2 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Fawzy Montasser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665766
- Sponsor's protocol ID
- ASU-1124568
- Status last verified
- Sep 2018
- First submitted
- 7 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cyclosporine A Versus Tacrolimus on the Response to Antiviral Treatment After HCV Genotype -4 Recurrence in Recipients of Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT03665766
- Acronym / sponsor ID
- ASU-1124568
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 May 2014 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Aim: The immunosuppression influence on the response to antiviral therapy (AVT) for recurrent hepatitis C virus (HCV) infection in liver transplant (LT) recipients remains controversial, especially for the rarely investigated genotype 4.This study aims to compare the effects of the two widely used calcineurin inhibitors(CNIs)(Cyclosporine A (CsA) and tacrolimus (Tac)) on the therapeutic response to different AVT regimens. Method: In126 living donor liver transplant (LDLT) recipients with recurrent HCV infection, participants were categorized to three groups according to AVT. Group one received pegylated interferon (Peg IFN-α 2a) and ribavirin (RBV) (n= 44), group two received the direct antiviral agent (DAA) sofosbuvir plus RBV (n=52) and group three received daclatasvir, sofosbuvir (other DAAs) plus RBV(n=30) each group was further subdivided according to primary immunosuppression (CsA or Tac). The sustained virological response (SVR) and relapse rates were considered the primary therapeutic outcomes of AVT. The virological response guided therapy end points for AVT were considered the secondary outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IFN group received Cyclosporine | – | Drug: Cycloserine,TacrolimusLiving donor liver transplantation recipients with recurrent HCV received Peg IFN-α 2a and RBV as antiviral therapy and Cyclosporine A as primary immunosuppression ,this was routinely taken not as intervention according to local practice |
| IFN group received tacrolimus | – | Drug: Cycloserine,TacrolimusLiving donor liver transplantation recipients with recurrent HCV received Peg IFN-α 2a and RBV as antiviral therapy and Tacrolimus as primary immunosuppression ,this was routinely taken not as interventing according to local practice |
| Sof plus Rbv group received Cyclosporine | – | Drug: Cycloserine,TacrolimusLiving donor liver transplantation recipients with recurrent HCV received sofosbuvir and RBV as antiviral therapy and Cyclosporine as primary immunosuppression,this was routinely taken not as intervention according to local practice |
| Sof plus Rbv received tacrolimus | – | Drug: Cycloserine,TacrolimusLiving donor liver transplantation recipients with recurrent HCV received sofosbuvir and RBV as antiviral therapy and Tacrolimus as primary immunosuppression,this was routinely taken not as intervention according to local practice |
| Sof,dac pus ribavirin received cyclosporine | – | Drug: Cycloserine,TacrolimusLiving donor liver transplantation recipients with recurrent HCV received daclatasvir, sofosbuvir and RBV as antiviral therapy and Cyclosporine as primary immunosuppression,this was routinely taken not as intervention according to local practice |
| sof,dac plus rbv received tacrolimus | – | Drug: Cycloserine,TacrolimusLiving donor liver transplantation recipients with recurrent HCV received daclatasvir, sofosbuvir and RBV as antiviral therapy and Tacrolimus as primary immunosuppression,this was routinely taken not as intervention according to local practice |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- living donor liver transplant (LDLT) recipients with recurrent HCV infection, participants were categorized to three groups according to AVT. Group one received pegylated interferon (Peg IFN-α 2a) and ribavirin (RBV) , group two received the direct antiviral agent (DAA) sofosbuvir plus RBV and group three received daclatasvir, sofosbuvir (other DAAs) plus RBV each group was further subdivided according to primary immunosuppression (CsA or Tac)
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- if they were younger than 18 years or older than 65 years or had one of the following criteria
- alcoholic
- poorly controlled autoimmune disease
- significant cardiac disease
- suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycloserine,Tacrolimus | Drug | IFN group received Cyclosporine, IFN group received tacrolimus, Sof plus Rbv group received Cyclosporine, Sof plus Rbv received tacrolimus, Sof,dac pus ribavirin received cyclosporine, sof,dac plus rbv received tacrolimus |
Primary outcome
sustained virological response
Time frame: 24 weeks for group I and 12 weeks for group II and III
a negative serum HCV RNA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sustained virological response (time frame: 24 weeks for group I and 12 weeks for group II and III). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.