A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
2016년 3월 21일 업데이트: Hoffmann-La Roche
Randomized, Multicenter, Double-blind, Phase IV Pilot Study Evaluating the Effect of PEGASYS Doses of 180 ug or 270 ug in Combination With Copegus Doses of 1200 mg or 1600 mg on Viral Kinetics, Virological Response, Pharmacokinetics, and Safety in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Body Weight Greater Than 85 kg
The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon.
The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
188
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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La Jolla, California, 미국, 92037-1030
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Long Beach, California, 미국, 90822
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San Diego, California, 미국, 92154
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San Diego, California, 미국, 92105
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Connecticut
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Farmington, Connecticut, 미국, 06030
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Florida
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Bradenton, Florida, 미국, 34209
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Gainesville, Florida, 미국, 32610-0214
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Jacksonville, Florida, 미국, 32207
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Wellington, Florida, 미국, 33414
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Hawaii
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Honolulu, Hawaii, 미국, 96817
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Illinois
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Chicago, Illinois, 미국, 60612
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Iowa
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Iowa City, Iowa, 미국, 52242
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Massachusetts
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Boston, Massachusetts, 미국, 02111
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Missouri
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St Louis, Missouri, 미국, 63104
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New York
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Manhasset, New York, 미국, 11030
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7584
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Statesville, North Carolina, 미국, 28677
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Ohio
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Cincinnati, Ohio, 미국, 45267-0595
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
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Pittsburgh, Pennsylvania, 미국, 15213
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Texas
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Houston, Texas, 미국, 77030
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Utah
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Salt Lake City, Utah, 미국, 84121
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Virginia
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Charlottesville, Virginia, 미국, 22906-0013
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Richmond, Virginia, 미국, 23249
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Santurce, 푸에르토 리코, 00909
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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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- adult patients >=18 years of age;
- body weight >85kg (187lbs);
- CHC (genotype 1);
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- use of 2 forms of contraception during study and 6 months after the study in both men and women.
Exclusion Criteria:
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection;
- previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: PEG-IFN Alfa-2a 180 μg +Ribavirin 1200 mg
Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
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600mg po bid for 48 weeks
800mg po bid for 48 weeks
180 micrograms sc weekly for 48 weeks
270 micrograms sc weekly for 48 weeks
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실험적: PEG-IFN Alfa-2a 180 μg + Ribavirin 1600 mg
Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
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600mg po bid for 48 weeks
800mg po bid for 48 weeks
180 micrograms sc weekly for 48 weeks
270 micrograms sc weekly for 48 weeks
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실험적: PEG-IFN Alfa-2a 270 μg + Ribavirin 1200 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
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600mg po bid for 48 weeks
800mg po bid for 48 weeks
180 micrograms sc weekly for 48 weeks
270 micrograms sc weekly for 48 weeks
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실험적: PEG-IFN Alfa-2a 270 μg + Ribavirin 1600 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
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600mg po bid for 48 weeks
800mg po bid for 48 weeks
180 micrograms sc weekly for 48 weeks
270 micrograms sc weekly for 48 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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HCV RNA Profile During The First 24 Weeks
기간: Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24
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Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed.
Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses.
Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL).
A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).
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Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24
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Percentage of Participants With Virological Response Over Time to Week 24
기간: 72 hours post-dose, Weeks 1, 2, 4, 12, and 24
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Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24.
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72 hours post-dose, Weeks 1, 2, 4, 12, and 24
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Percentage of Participants With Predicted Sustained Virological Response
기간: Week 4 and 12
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The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12.
Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was <0.5.
The percentage was calculated from the number of participant (N) analyzed under "Distribution of the predicted probability of an SVR."
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Week 4 and 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Sustained Virological Response
기간: Week 72
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SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period.
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Week 72
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Percentage of Participants With Virological Response at the End of the Treatment Period
기간: Week 48
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Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period.
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Week 48
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Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period
기간: Week 60
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Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period.
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Week 60
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Percentage of Participants With Adverse Events and Serious Adverse Events
기간: Up to Week 72
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An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
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Up to Week 72
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Percentage of Participants With Marked Laboratory Abnormalities
기간: Up to Week 60
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Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 - 20.0 (g/dL),platelets 100 - 700 (10^9/L), lymphocyte 1.00 - 6.30 (10^9/L),neutrophils 1.50 or more (10^9/L), white blood cells(WBC) 3.0 - 18.0 (10^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 - 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 - 50 (U/L), alkaline phosphatase 0 - 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 - 120 (U/L),Total protein 55 - 87 (g/L),total bilirubin 0 - 34.2 (μmol/L),BUN 0 - 14.3 (mmol/L),creatinine 0 - 154 (μmol/L),chloride 95 - 115 (mmol/L),potassium 3.0 - 6.0 (mmol/L), sodium 130 - 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 - 10.0 (mU/L),triglycerides 0.00 - 2.83 (mmol/L), calcium 2.00 - 2.90 (mmol/L),phosphate 0.75 - 1.60 (mmol/L),Blood Glucose 2.80 - 11.10 (mmol/L),Uric Acid 0 - 600 (μmol/L),proteinuria 0 - 1 (0 to 4+), glycosuria 0 - 1 (0 to 4+), hematuria 0 - 1 (0 to 4+).
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Up to Week 60
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Percentage of Participants With Abnormal Vital Signs
기간: Up to Week 72
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Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening.
High diastolic blood pressure is defined as >110 mmhg and >20% increase from baseline.
High systolic blood pressure is defined as >180 mmhg and >20% increase from baseline.
Low systolic blood pressure is defined as <85 mmhg and >20% decrease from baseline.
High heart rate is defined as >120 beats/minute and >20% increase from baseline.
Low heart rate is defined as < 50 beats/minute and >20% decrease from baseline.
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Up to Week 72
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Total BDI-II (Beck Depression Inventory) Scores
기간: From Baseline (Day 1) to Week 72
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The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group.
All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63.
The scores for each item were summed to obtain the total for that assessment.
The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63.
The BDI-II questionnaire was self-administered by the patient at each visit.
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From Baseline (Day 1) to Week 72
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
2004년 1월 1일
기본 완료 (실제)
2005년 12월 1일
연구 완료 (실제)
2005년 12월 1일
연구 등록 날짜
최초 제출
2004년 2월 10일
QC 기준을 충족하는 최초 제출
2004년 2월 12일
처음 게시됨 (추정)
2004년 2월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 4월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 3월 21일
마지막으로 확인됨
2016년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NV17318
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