Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
A Phase 2, Multicenter, Open-Label, Randomized Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin Administered for 48 Weeks in Patients Infected With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Auckland
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Grafton, Auckland, 뉴질랜드
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Colorado
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Aurora, Colorado, 미국
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Massachusetts
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Boston, Massachusetts, 미국
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Minnesota
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Rochester, Minnesota, 미국
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Pennsylvania
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Philadelphia, Pennsylvania, 미국
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Barcelona, 스페인
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Madrid
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Majadahonda, Madrid, 스페인
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Clichy
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Leclerc, Clichy, 프랑스
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New South Wales
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Newtown, New South Wales, 호주
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Chronic infection with Hepatitis C with HCV RNA > 1000 IU/mL
- Individuals with cirrhosis with Child-Pugh score < 10
- Esophageal or gastric varices on endoscopy within 6 months prior to or at screening
- Hepatic Venous Pressure Gradient (HVPG) > 6 mmHg
- Body mass index (BMI) ≥ 18 kg/m^2
- Naïve to all nucleotides/nucleoside treatments for chronic HCV infection
Exclusion Criteria:
- Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
- HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
- Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening
- Refractory ascites as defined by requiring paracentesis > twice within 1 month prior to screening
- Active variceal bleeding within 6 months of screening
- Expected survival of < 1 year
- History of hepatorenal, or hepatopulmonary syndrome.
- Evidence of renal impairment (CrCl < 50 mL/min)
- History of major organ transplantation, including liver transplant.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: SOF+RBV
Participants will receive SOF+RBV for 48 weeks.
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패키지 삽입 체중 기반 투여 권장사항(< 75kg = 1000mg 및 ≥ 75kg = 1200mg)에 따라 분할 일일 용량으로 경구 투여되는 RBV 정제
SOF 400 mg 정제를 1일 1회 경구 투여
다른 이름들:
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실험적: Observation, then SOF+RBV
Participants will undergo 24 weeks of observation and then receive SOF+RBV for 48 additional weeks.
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패키지 삽입 체중 기반 투여 권장사항(< 75kg = 1000mg 및 ≥ 75kg = 1200mg)에 따라 분할 일일 용량으로 경구 투여되는 RBV 정제
SOF 400 mg 정제를 1일 1회 경구 투여
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
기간: Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation)
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SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
For the Observation/SOF+RBV group, SVR12 during the observational period was defined as HCV RNA < LLOQ for 12 consecutive weeks, any time during the observational period.
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Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
기간: Posttreatment Weeks 4, 24, and 48
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SVR4, SVR24, and SVR48 were defined as HCV RNA < LLOQ at 4, 24, and 48 weeks after stopping study treatment, respectively.
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Posttreatment Weeks 4, 24, and 48
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Percentage of Participants Experiencing On-Treatment Virologic Failure
기간: Up to 48 weeks
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On-treatment virologic failure was defined as:
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Up to 48 weeks
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Percentage of Participants Experiencing Viral Relapse
기간: Up to Posttreatment Week 24
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Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
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Up to Posttreatment Week 24
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Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment
기간: Baseline; Week 24 (Observation) and Week 48 (SOF+RBV)
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HVPG closely reflects the degree of portal hypertension in patients with cirrhosis.
The end of treatment for the Observation group was defined as the end of the observation period.
The treatment period for Group 2 was defined as the end of the observation period to the end of the treatment.
Baseline values were the last available values on or prior to first dose date of any study drug.
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Baseline; Week 24 (Observation) and Week 48 (SOF+RBV)
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Change From Baseline in Child-Pugh-Turcotte (CPT) Score
기간: Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)
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CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. Data are presented as improvement, no change, or worsening in CPT scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups). Improvement in CPT score was defined as having a decrease in CPT score from baseline, no change in CPT score was defined as having no change in CPT score from baseline, and worsening in CPT score was defined as having an increase in CPT score from baseline. Baseline values were the last available values on or prior to first dose date of any study drug. |
Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)
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Change From Baseline in Model for End Stage Liver Disease (MELD) Scores
기간: Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)
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MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. Data are presented as improvement, no change, or worsening in MELD scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups). Improvement in MELD score was defined as having a baseline MELD score of 11-15 or 16-20 that changed to 0-10, or a baseline MELD score of 16-20 that changed to 11-15; no change in MELD score was defined as having no change in score group (0-10, 11-15, or 16-20) from baseline; and worsening in MELD score was defined as having a baseline MELD score of 0-10 that changed to 11-15 or 16-20, or a baseline MELD score of 11-15 that changed to 16-20. Baseline values were the last available values on or prior to first dose date of any study drug. |
Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
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연구 기록 업데이트
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추가 정보
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