Observational, Multi-Center Study of the Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation (HCV RWE)
2018년 10월 18일 업데이트: AbbVie
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation - An Observational, Multi-Center Study
This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.
연구 개요
연구 유형
관찰
등록 (실제)
158
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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.
설명
Inclusion Criteria:
Patients are eligible for observation in this cohort if the following applies:
- Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label
- If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
- Patients must voluntarily sign and date informed consent prior to inclusion into the study
Exclusion Criteria:
- Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Participants With Chronic Hepatitis C Genotype 1
Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)
기간: 12 weeks after the last actual dose of study drug
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SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
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12 weeks after the last actual dose of study drug
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse
기간: 12 weeks after last actual dose of study drug
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Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.
Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
Relapse is defined as HCV RNA < 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
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12 weeks after last actual dose of study drug
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SVR12 Non-Response: Percentage of Participants With Breakthrough
기간: 12 weeks after the last actual dose of study drug
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Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.
|
12 weeks after the last actual dose of study drug
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SVR12 Non-Response: Percentage of Participants With Failure to Suppress
기간: 12 weeks after the last actual dose of study drug
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Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
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12 weeks after the last actual dose of study drug
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SVR12 Non-Response: Percentage of Participants With Relapse
기간: 12 weeks after last actual dose of study drug
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Relapse is defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
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12 weeks after last actual dose of study drug
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SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure
기간: 12 weeks after last actual dose of study drug
|
On-treatment virologic failure included virological breakthrough and failure to suppress.
Virological breakthrough was defined as at least one documented HCV RNA < 50 IU/mL or undetectable/negative followed by HCV RNA ≥ 50 IU/mL during treatment.
Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
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12 weeks after last actual dose of study drug
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SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data
기간: 12 weeks after last actual dose of study drug
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12 weeks after last actual dose of study drug
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Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
기간: 24 weeks after last actual dose of study drug
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SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
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24 weeks after last actual dose of study drug
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Percentage of Participants Achieving Virological Response at End of Treatment
기간: From baseline until end of treatment (12 or 24 weeks after actual first dose)
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Virologic response is defined as HCV RNA < 50 IU/mL.
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From baseline until end of treatment (12 or 24 weeks after actual first dose)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Achieving SVR12: Additional Analysis
기간: 12 weeks after the last actual dose of study drug
|
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL or undetectable/negative 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
|
12 weeks after the last actual dose of study drug
|
|
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis
기간: 12 weeks after last actual dose of study drug
|
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment.
Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.
|
12 weeks after last actual dose of study drug
|
|
SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis
기간: 12 weeks after the last actual dose of study drug
|
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment.
|
12 weeks after the last actual dose of study drug
|
|
SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis
기간: 12 weeks after the last actual dose of study drug
|
Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
|
12 weeks after the last actual dose of study drug
|
|
SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis
기간: 12 weeks after last actual dose of study drug
|
Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.
|
12 weeks after last actual dose of study drug
|
|
Percentage of Participants Achieving SVR24: Additional Analysis
기간: 24 weeks after last actual dose of study drug
|
SVR24 is defined as HCV RNA levels < 50 IU/mL or undetectable/negative 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
|
24 weeks after last actual dose of study drug
|
|
Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis
기간: From baseline until end of treatment (12 or 24 weeks after actual first dose)
|
Virologic response is defined as HCV RNA < 50 IU/mL or undetectable/negative.
|
From baseline until end of treatment (12 or 24 weeks after actual first dose)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Andrey Strugovschikov, MD, AbbVie
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
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 (실제)
2016년 4월 15일
기본 완료 (실제)
2017년 7월 4일
연구 완료 (실제)
2017년 7월 4일
연구 등록 날짜
최초 제출
2016년 1월 28일
QC 기준을 충족하는 최초 제출
2016년 1월 28일
처음 게시됨 (추정)
2016년 2월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 11월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 10월 18일
마지막으로 확인됨
2018년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P15-743
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. .