Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients

NCT ID: NCT03880682

Last Updated: 2019-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant; Complications Hepatitis C, Chronic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Study Group

Kidney transplant recipients with chronic HCV infection who were treated using direct acting antivirals.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Safak Mirioglu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Safak Mirioglu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Istanbul Faculty of Medicine

Halil Yazici, MD

Role: STUDY_CHAIR

Department of Internal Medicine, Istanbul Faculty of Medicine

Sabahattin Kaymakoglu, MD

Role: STUDY_CHAIR

Department of Internal Medicine, Istanbul Faculty of Medicine

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, Yun C, Massetto B, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Ann Intern Med. 2017 Jan 17;166(2):109-117. doi: 10.7326/M16-1205. Epub 2016 Nov 15.

Reference Type BACKGROUND
PMID: 27842383 (View on PubMed)

Other Identifiers

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2018/1511

Identifier Type: -

Identifier Source: org_study_id

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