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Trial record 66 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT03880682
Recruitment Status : Active, not recruiting
First Posted : March 19, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Safak Mirioglu, Istanbul University

Brief Summary:
Chronic hepatitis C virus (HCV) infection, an important cause of morbidity and mortality worldwide, is a significant problem in kidney transplant recipients (KTRs) given its high prevalence in patients undergoing hemodialysis. Interferon based regimens were cornerstone of treatment of HCV infection in the past; however, due to their low efficacy and high rates of adverse effects, they have been abandoned in the new era of direct acting antivirals (DAAs). Several studies demonstrated the efficacy and safety of DAAs, yet data regarding clinical practice of these agents in KTRs is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of DAAs in KTRs.

Condition or disease
Kidney Transplant; Complications Hepatitis C, Chronic

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Treatment of Chronic Hepatitis C Virus Infection With Direct Acting Antivirals in Kidney Transplant Recipients
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : June 15, 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Study Group
Kidney transplant recipients with chronic HCV infection who were treated using direct acting antivirals.



Primary Outcome Measures :
  1. SVR12 [ Time Frame: 6 months ]
    Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals.


Secondary Outcome Measures :
  1. Stable Graft Function [ Time Frame: 6-12 months ]
    Stability of serum creatinine and proteinuria levels of kidney transplant recipients during and after the treatment with direct acting antivirals.

  2. Stable Serum Trough Levels of Immunosuppressive Agents [ Time Frame: 6 months ]
    Stability of serum trough levels of calcineurin and mTOR inhibitors during the treatment with direct acting antivirals.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Kidney transplant recipients with chronic HCV infection who were treated using direct acting antivirals.
Criteria

Inclusion Criteria:

  • Being a kidney transplant recipient.
  • Having a detectable level of HCV RNA.
  • Having direct acting antivirals for 12 or 24 weeks.

Exclusion Criteria:

  • Withdrawing or not providing consent.

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): NCT03880682


Locations
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Turkey
Istanbul University
Istanbul, Turkey
Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Safak Mirioglu, MD Department of Internal Medicine, Istanbul Faculty of Medicine
Study Chair: Halil Yazici, MD Department of Internal Medicine, Istanbul Faculty of Medicine
Study Chair: Sabahattin Kaymakoglu, MD Department of Internal Medicine, Istanbul Faculty of Medicine

Publications:
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Responsible Party: Safak Mirioglu, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier: NCT03880682     History of Changes
Other Study ID Numbers: 2018/1511
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Safak Mirioglu, Istanbul University:
kidney transplant recipients
chronic hepatitis c virus infection
direct acting antivirals
sofosbuvir/ledipasvir
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Infection
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
Anti-Infective Agents