Extension Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Peg-INF and RBV After Completing Treatment in HCV
An Extension of Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Pegylated Interferon and Ribavirin After Completing Treatment in a Phase 2 Study and Have Relapsed After at Least 44 Weeks Tx With Peg-IFN and RBV.
연구 개요
상세 설명
In this extension study, subjects will be asked to give permission to share their HCV RNA viral load test results, obtained from local laboratories, at the different time points and will also be asked to give permission to share their SOC dosing information (peg-IFN and RBV). As no SCV-07 treatment, procedures, or assessments will be required during this extension study, no related safety information will be collected.
The study will last up to 72 weeks after subjects complete treatment on study SCI-SCV-HCV-P2-001 and begin retreatment with peg-IFN and RBV.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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California
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Anaheim, California, 미국, 92803
- AGMG Clinical Research
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Kentucky
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Louisville, Kentucky, 미국
- Univ of Louisville Med/Dental Complex
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Ohio
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Cincinnati, Ohio, 미국, 45267
- University of Cincinnati Medical Center
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Washington
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Washington, Washington, 미국, 20307
- Walter Reed Army Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Subjects who satisfy all of the following criteria may be enrolled into the study:
Subjects must be able to understand and sign an ICF approved by the investigator's institutional review board (IRB) for this study; must have completed treatment on study SCI-SCV-HCV-P2-001; and must, in the judgment of the investigators, be able to benefit from retreatment per current SOC (peg-IFN and RBV).
Exclusion Criteria:
- Subjects who satisfy any of the following criteria will not be enrolled into the study:
Subjects who, in the opinion of the investigators, will be unable to tolerate retreatment with peg-IFN and RBV for at least 48 weeks and are at high risk of early treatment discontinuation and plan to participate in another investigational trial prior to providing a final sample for this trial.
공부 계획
연구는 어떻게 설계됩니까?
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Hepatitis C treatment
This is an extension of ongoing study SCI-SCV-HCV-P2-001.
Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
|
This is an extension of ongoing study SCI-SCV-HCV-P2-001.
Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
|
|
non cirrhotic subjects
This is an extension of ongoing study SCI-SCV-HCV-P2-001.
Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
|
This is an extension of ongoing study SCI-SCV-HCV-P2-001.
Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Katharina Modelska, MD, SciClone Pharmaceuticals
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SCI-SCV-HCV-P2-001-Extension
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