36 vs 48 Wks Peg-Intron Plus Ribavirin for HCV Patients Without Rapid Virologic Response But Without HCV RNA at wk 8
NCT ID: NCT01683786
Last Updated: 2012-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2011-08-31
2014-12-31
Brief Summary
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To compare the effectiveness of 36 weeks versus 48 weeks pegintron plus ribavirin treatment for hepatitis C virus(HCV) patients without rapid virologic response(RVR), but with undetectable HCV RNA at wk 8.
Study Design:
a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype 1 patients who fail to achieve RVR but achieve undetectable HCV RNA at week 8 (\<50 IU/ml) will be recruited into 2 arms(30 in each arm). Patients must receive pegylated interferon-α2b at 1.5 μg/kg of body weight/week and ribavirin 800\~1400 mg/day for 12 wks before entering this study.
Detailed Description
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To compare the effectiveness of 36 wks versus 48 wks pegintron plus ribavirin treatment for HCV patients without RVR, but with undetectable HCV RNA at wk 8.
Study Design:
This is a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype 1 patients who fail to achieve RVR at wk 4 but achieve undetectable HCV RNA at wk 8 (\<50 IU/ml) will be recruited into 2 arms(30 in each arm). Patients must receive pegylated IFN-α2b at 1.5 μg/kg of body weight/week and ribavirin 800\~1400 mg/day for 12 wks before entering this study.
Study Duration:
The estimated recruitment period is 12 months; the follow-up duration is 72 weeks (longest treatment period plus 6 month- f/u period); the total study duration (FPE-\>LPLV) is estimated to be 2.5 years
Statistical Analysis and Sample Size Justification:
A. The study is not primarily designed for hypothesis testing; thus the sample size calculation is not based on the primary objective, Approximately 60 subjects (30 in each arm) will be recruited into this study B. For descriptive statistics, the continuous variables will be expressed as mean ± standard deviation, and the categorical variables will be performed the number of cases and the corresponding percentages.
The primary analysis will focus on the efficacy response to the shortened HCV treatment course (36 wks) compared with standard course (48 wks). The between-group difference for efficacy endpoint will be assessed by the difference in the percentage of virologic responder after 24 wks of HCV treatment. For univariate analyses, comparisons of independent samples (shortened vs. standard course) will be assessed with Student's t test. The comparisons of categorical variables will be assessed using the chi-square test. Regarding the multivariate analysis, the proportion of patients achieving virologic responder will be compared among groups using a logistic regression analysis with terms of potential confounding factors. The OR estimates will be derived from the logistic regression model and the corresponding 95% CIs will be used to quantify the each effect of treatment course length and confounding factors.
All randomized patients who take at least one dose of HCV regimen will be included in safety assessment. Fisher's exact test will be used to compare between-group incidences of AEs. For patients with any clinical AEs, treatment related AEs, serious AEs, or discontinuations because of AEs, the data among groups will be provided as well. Statistical significance will be determined at the 0.05 level for all tests.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pegintron + Riba for 36 wks in total
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800\~1400 mg/day for 24 weeks (36 weeks in total HCV treatment)
Pegintron + Riba
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800\~1400 mg/day
Pegintron + Riba for 48 wks in total
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800\~1400 mg/day for 36 weeks (48 weeks in total HCV treatment)
Pegintron + Riba
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800\~1400 mg/day
Interventions
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Pegintron + Riba
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800\~1400 mg/day
Eligibility Criteria
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Inclusion Criteria
2. Positive for the HCV antibody and HCV RNA detected with abnormal ALT (≧ 1X) before initiating PegIFN plus RBV treatment
3. HCV Genotype 1
4. Have failed to achieve RVR at week 4 but achieve undetectable HCV RNA at week 8 (\< 50 IU/ml) with PegIFN plus RBV treatment
5. Have received PegIFN plus RBV treatment for 12weeks with good compliance (who have received \>80% of expected PegIFN and RBV doses and completed at least 80% of the expected duration (80/80/80 adherence) and achieve EVR before entering this study
Exclusion Criteria
2. With prior exposures to interferon (standard or pegylated) treatment before baseline.
3. With human immunodeficiency virus
4. With hepatitis B infection
5. With neutrophil count \< 1500 mm3,
6. With platelet count \< 90000 mm3,
7. With hemoglobin level \< 12g/dL for men or \< 11 g/dL for women
8. With serum creatinine level \> 1.5 mg/dL
9. With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases
10. Female patients with pregnancy or lactation. Pregnancy in partners of male patients.
11. Hypersensitive to study drugs cases.
20 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Tsung-Hui Hu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Medical Foundation, Kaohsiung Branch
Locations
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Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation, Kaohsiung Branch
Kaohsiung City, , Taiwan
Pingtung Christian Hospital
Pingtung City, , Taiwan
Chi Mei Medical Center - Liouying Branch
Tainan City, , Taiwan
Shin Kong Wu Ho-Su Memorial Hosipital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Hsien-Chung Yu, M.D.
Role: primary
Tsung-Hui Hu, M.D.
Role: primary
Lian-Feng Lin, M.D.
Role: primary
Jyh-Jou Chen, M.D.
Role: primary
Chao-Sheng Liao, M.D.
Role: primary
Other Identifiers
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MISP39068
Identifier Type: -
Identifier Source: org_study_id