Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients

Hepatitis C, Chronic Clinical Trial

Official title:

Treatment of Chronic Hepatitis C Virus Infection With Direct Acting Antivirals in Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880682
• Other study ID #: 2018/1511
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: November 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Infection
• Kidney Transplant; Complications

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, Yun C, Massetto B, Brainard DM, McHutchison JG, Bourlière 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR12	Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals.	6 months
Secondary	Stable Graft Function	Stability of serum creatinine and proteinuria levels of kidney transplant recipients during and after the treatment with direct acting antivirals.	6-12 months
Secondary	Stable Serum Trough Levels of Immunosuppressive Agents	Stability of serum trough levels of calcineurin and mTOR inhibitors during the treatment with direct acting antivirals.	6 months