Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients

NCT03880682 | Completed

• 1 other identifier: 2018/1511
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Complications; Hepatitis C, Chronic

Keywords

kidney transplant recipients; chronic hepatitis c virus infection; direct acting antivirals; sofosbuvir/ledipasvir

Outcome Measures

Primary Outcomes (1)

• SVR12

  Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals.

  6 months

Secondary Outcomes (2)

• Stable Graft Function

  6-12 months

• Stable Serum Trough Levels of Immunosuppressive Agents

  6 months

Study Arms (1)

Study Group

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Withdrawing or not providing consent.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 27842383 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Safak Mirioglu, MD

  Department of Internal Medicine, Istanbul Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Halil Yazici, MD

  Department of Internal Medicine, Istanbul Faculty of Medicine

  STUDY CHAIR

• Sabahattin Kaymakoglu, MD

  Department of Internal Medicine, Istanbul Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 19, 2019
• Study Start: November 1, 2018
• Primary Completion: June 15, 2019
• Study Completion: October 31, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)