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

NCT03105349 | Withdrawn Phase 4

• 1 other identifier: GESIDA 9516
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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

Conditions

HCV

Outcome Measures

Primary Outcomes (1)

• The rate of patients achieved SVR12

  Week 12 post treatment

Secondary Outcomes (13)

• The proportion of subjects infected with HCV genotype 1a with reference VARs NS5A / NS3 who achieved RVS12.

  Week 12 post treatment

• The proportion of subjects infected with HCV genotype 1b with reference VARs NS5A / NS3 who achieved RVS12.

  Week 12 post treatment

• The proportion of subjects infected with HCV genotype 4 with reference VARs NS5A /NS3 who achieved RVS12.

  Week 12 post treatment

• The proportion of subjects infected with HCV genotypes 1.4 with reference VARs NS5A /NS3 who achieved RVS24.

  Week 24 post treatment

• The occurrence of Viral resistance variants (VARs) to NS5A or elbasvir, to NS3 or grazoprevir and to NS5B or SOF in patients who did not reach SVR12 after 16 weeks of re-treatment

  Week 16

Study Arms (1)

Single arm

EXPERIMENTAL

16 weeks treatment with elbasvir/grazoprevir plus sofosbuvir and ribavirina

Drug: elbasvir/grazoprevir; Drug: Sofosbuvir; Drug: Ribavirin

Interventions

elbasvir/grazoprevir DRUG

16 weeks treatment

Also known as: Zepatier

Single arm

Sofosbuvir DRUG

16 weeks treatment

Single arm

Ribavirin DRUG

16 weeks treatment

Single arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion SEIMC-GESIDA: lead

Study Sites (5)

Hospital Univ. La Paz

Madrid, Madri, 28046, Spain

Location

Hospital Univ. Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Infanta Leonor

Madrid, 28031, Spain

Location

Hospita 12 de octubre

Madrid, 28041, Spain

Location

Hospital Univ. La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Interventions

elbasvir-grazoprevir drug combination; Sofosbuvir; Ribavirin

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: April 7, 2017
• Study Start: July 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: June 8, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)