A Phase III, Open Label, Multicentric Clinical Trial of a Single Arm of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotype 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A

Status: Withdrawn
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This is a phase 4 clinical trial to treat patients who have failed to treat with regimen based on an inhibitor of the NS5A

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Adults with chronic HCV genotype 1, 4 infection with or without HIV infection aged 18 years or above

• HCV RNA plasma concentration of at least 1000 IU / mL

• Subjects previously treated with NS5A-based regimens for at least 8 weeks.

• Patients with HCV relapse after receiving a complete treatment with NS5A-based AAD regimen for at least 8 weeks and becoming undetectable at the end of treatment. Relapse is defined as a confirmed HCV RNA detectable upon completion of therapy of A5 based on NS5A against HCV.

• Subjects with compensated hepatic cirrhosis (Child A) could be included.

• For patients with HIV coinfection:

‣ Be infected with HIV-1, documented by any rapid HIV test with the corresponding license and confirmed by a Western blot or second antibody test using a method other than the initial rapid HIV and / or I / CIA method or by HIV-1 p24 antigen or viral load of HIV-1 RNA plasma.

⁃ Be on stable HIV antiretroviral therapy (ART) for at least 4 weeks prior to entry into the study using a dual ITN backbone of tenofovir or abacavir and emtricitabine or lamivudine PLUS raltegravir or dolutegravir or rilpivirine (with CD4 + T cell count\> 100 cells / mm 3 and undetectable HIV-1 RNA at baseline. Results from prior analysis will be accepted within 24 weeks prior to study entry).

Locations
Other Locations
Spain
Hospita 12 de octubre
Madrid
Hospital Infanta Leonor
Madrid
Hospital Univ. Gregorio Marañon
Madrid
Hospital Univ. La Paz
Madrid
Hospital Univ. La Paz
Madrid
Time Frame
Start Date: 2017-07-01
Completion Date: 2018-02
Treatments
Experimental: Single arm
16 weeks treatment with elbasvir/grazoprevir plus sofosbuvir and ribavirina
Related Therapeutic Areas
Sponsors
Leads: Fundacion SEIMC-GESIDA

This content was sourced from clinicaltrials.gov