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

NCT ID: NCT03105349

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-02-28

Brief 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

Detailed Description

The duration of the treatment will be 16 weeks and then will be a security perid with 2 visits (Week 12 post treatment and week 24 post treatment) The study in an open label study with a single arm .

Conditions

HCV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

16 weeks treatment with elbasvir/grazoprevir plus sofosbuvir and ribavirina

Group Type: EXPERIMENTAL

elbasvir/grazoprevir

Intervention Type: DRUG

16 weeks treatment

Sofosbuvir

Intervention Type: DRUG

16 weeks treatment

Ribavirin

Intervention Type: DRUG

16 weeks treatment

Interventions

elbasvir/grazoprevir

16 weeks treatment

Intervention Type: DRUG

Sofosbuvir

16 weeks treatment

Intervention Type: DRUG

Ribavirin

16 weeks treatment

Intervention Type: DRUG

Other Intervention Names

Zepatier

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• Subjects with hepatitis other than C or steatosis.
• Subjects previously treated less than 8 weeks with regimens based on NS5A.
• Evidence of previous hepatocellular carcinoma although it has criteria of cure
• Subjects with past or current decompensated liver disease; Only decompensated patients who have received a liver transplant and have not decompensated after transplantation will be included.
• Subjects suspected of clinical or genotypic reinfection of HCV.
• Subject with HCV response regrowth while receiving NS5A-based ADA therapy against HCV. Said regrowth is defined as a confirmation of detectable HCV RNA after achieving undetectable HCV RNA during NS5A-based AADs against HCV.
• Recent history of drug or alcohol abuse.
• Important comorbidities.

• Pregnant, lactating or non-lactating women Contraceptives, if they are women of childbearing age. Women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months.
• Subjects with a glomerular filtration rate of less than 30 ml / min.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion SEIMC-GESIDA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Univ. La Paz

Madrid, Madri, Spain

Hospital Univ. Gregorio Marañon

Madrid, , Spain

Hospital Infanta Leonor

Madrid, , Spain

Hospita 12 de octubre

Madrid, , Spain

Hospital Univ. La Paz

Madrid, , Spain

Countries

Spain

Other Identifiers

GESIDA 9516

Identifier Type: -

Identifier Source: org_study_id