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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 (C-RESCUE)

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ClinicalTrials.gov Identifier: NCT03105349
Recruitment Status : Withdrawn (No availability of investigational medication.)
First Posted : April 7, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA

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

Condition or disease Intervention/treatment Phase
HCV Drug: elbasvir/grazoprevir Drug: Sofosbuvir Drug: Ribavirin Phase 4

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm
16 weeks treatment with elbasvir/grazoprevir plus sofosbuvir and ribavirina
Drug: elbasvir/grazoprevir
16 weeks treatment
Other Name: Zepatier

Drug: Sofosbuvir
16 weeks treatment

Drug: Ribavirin
16 weeks treatment




Primary Outcome Measures :
  1. The rate of patients achieved SVR12 [ Time Frame: Week 12 post treatment ]

Secondary Outcome Measures :
  1. The proportion of subjects infected with HCV genotype 1a with reference VARs NS5A / NS3 who achieved RVS12. [ Time Frame: Week 12 post treatment ]
    To analyze the impact of VARs NS5A/NS3 on RVS12

  2. The proportion of subjects infected with HCV genotype 1b with reference VARs NS5A / NS3 who achieved RVS12. [ Time Frame: Week 12 post treatment ]
    Analyze the impact of VARs NS5A/NS3 on RVS12

  3. The proportion of subjects infected with HCV genotype 4 with reference VARs NS5A /NS3 who achieved RVS12. [ Time Frame: Week 12 post treatment ]
    Analyze the impact of VARs NS5A/NS3 on RVS12

  4. The proportion of subjects infected with HCV genotypes 1.4 with reference VARs NS5A /NS3 who achieved RVS24. [ Time Frame: Week 24 post treatment ]
    Analyze the impact of VARs NS5A/NS3 on RVS24

  5. 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 [ Time Frame: Week 16 ]
    the occurrence of resistance in patients who did not reach SVR12 after 16 weeks of re-treatment

  6. The occurrence of resistance variants (VARs) viral to NS5A or elbasvir, to NS3 or grazoprevir, and to NS5B or SOF in HIV patients included [ Time Frame: Week 12 post treatment ]

    The impact of VARs NS5A/NS3 on RVS12

    The proportion of subjects developing HIV-1 virological failure (HIV RNA> 200 Copies / mL), confirmed in 2 consecutive tests with at least 2 weeks between them.


  7. The proportion of subjects developing HIV-1 virological failure (HIV RNA> 200 Copies / mL), confirmed in 2 consecutive tests with at least 2 weeks between them [ Time Frame: Week 4, week 8, week 12 and week 16 ]
    the impact of treatment with EL / BRA plus SOFT and ribavirin in HIV-1 subjects

  8. The proportion of subjects experiencing adverse events of high laboratory values who report as ECI at any time during the study period. [ Time Frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment ]
    Adverse events

  9. The proportion of subjects with at least one adverse experience [ Time Frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment ]
    Adverse events

  10. The proportion of subjects with an adverse experience related to medication [ Time Frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment ]
    Adverse events

  11. The proportion of subjects with a severe adverse experience [ Time Frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment ]
    Adverse events

  12. The proportion of subjects with a serious adverse experience related to medication [ Time Frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment ]
    Adverse events

  13. The proportion of subjects with an adverse experience leading to disruption [ Time Frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment ]
    Adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105349


Locations
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Spain
Hospital Univ. La Paz
Madrid, Madri, Spain, 28046
Hospital Univ. Gregorio Marañon
Madrid, Spain, 28007
Hospital Infanta Leonor
Madrid, Spain, 28031
Hospita 12 de octubre
Madrid, Spain, 28041
Hospital Univ. La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Fundacion SEIMC-GESIDA

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Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT03105349     History of Changes
Other Study ID Numbers: GESIDA 9516
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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MK-5172
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents