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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)

2018년 6월 7일 업데이트: Fundacion SEIMC-GESIDA

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

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

연구 개요

상태

빼는

정황

개입 / 치료

상세 설명

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 .

연구 유형

중재적

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 스페인
      • Madrid, 스페인, 28031
        • Hospital Infanta Leonor
      • Madrid, 스페인, 28007
        • Hospital Univ. Gregorio Marañon
      • Madrid, 스페인, 28041
        • Hospita 12 de octubre
      • Madrid, 스페인, 28046
        • Hospital Univ. La Paz
    • Madri
      • Madrid, Madri, 스페인, 28046
        • Hospital Univ. La Paz

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Single arm
16 weeks treatment with elbasvir/grazoprevir plus sofosbuvir and ribavirina
의약품: elbasvir/grazoprevir
16 weeks treatment
다른 이름들:
  • 제파티에
의약품: Sofosbuvir
16 weeks treatment
의약품: Ribavirin
16 weeks treatment

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
The rate of patients achieved SVR12
기간: Week 12 post treatment
Week 12 post treatment

2차 결과 측정

결과 측정
측정값 설명
기간
The proportion of subjects infected with HCV genotype 1a with reference VARs NS5A / NS3 who achieved RVS12.
기간: Week 12 post treatment
To analyze the impact of VARs NS5A/NS3 on RVS12
Week 12 post treatment
The proportion of subjects infected with HCV genotype 1b with reference VARs NS5A / NS3 who achieved RVS12.
기간: Week 12 post treatment
Analyze the impact of VARs NS5A/NS3 on RVS12
Week 12 post treatment
The proportion of subjects infected with HCV genotype 4 with reference VARs NS5A /NS3 who achieved RVS12.
기간: Week 12 post treatment
Analyze the impact of VARs NS5A/NS3 on RVS12
Week 12 post treatment
The proportion of subjects infected with HCV genotypes 1.4 with reference VARs NS5A /NS3 who achieved RVS24.
기간: Week 24 post treatment
Analyze the impact of VARs NS5A/NS3 on 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
기간: Week 16
the occurrence of resistance in patients who did not reach SVR12 after 16 weeks of re-treatment
Week 16
The occurrence of resistance variants (VARs) viral to NS5A or elbasvir, to NS3 or grazoprevir, and to NS5B or SOF in HIV patients included
기간: 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.
Week 12 post treatment
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
기간: Week 4, week 8, week 12 and week 16
the impact of treatment with EL / BRA plus SOFT and ribavirin in HIV-1 subjects
Week 4, week 8, week 12 and week 16
The proportion of subjects experiencing adverse events of high laboratory values who report as ECI at any time during the study period.
기간: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
Adverse events
Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with at least one adverse experience
기간: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
Adverse events
Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with an adverse experience related to medication
기간: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
Adverse events
Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with a severe adverse experience
기간: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
Adverse events
Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with a serious adverse experience related to medication
기간: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
Adverse events
Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with an adverse experience leading to disruption
기간: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
Adverse events
Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fundacion SEIMC-GESIDA

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2017년 7월 1일

기본 완료 (예상)

2017년 12월 1일

연구 완료 (예상)

2018년 2월 1일

연구 등록 날짜

최초 제출

2017년 3월 16일

QC 기준을 충족하는 최초 제출

2017년 4월 6일

처음 게시됨 (실제)

2017년 4월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 6월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 6월 7일

마지막으로 확인됨

2018년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GESIDA 9516

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

HCV에 대한 임상 시험

elbasvir/grazoprevir에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Turkmenistan

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다