36 vs 48 Wks Peg-Intron Plus Ribavirin for HCV Patients Without Rapid Virologic Response But Without HCV RNA at wk 8
An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Effectiveness of 36 vs 48 Wks PegIntron Plus Ribavirin Treatment for HCV Patients Without Rapid Virologic Response(RVR) But With Undetectable HCV RNA at wk 8
1 other identifier
interventional
60
1 country
5
Brief Summary
Purpose: 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2011
Typical duration for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
September 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 12, 2012
September 1, 2012
3.3 years
January 31, 2012
September 11, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of sustained virologic response
The comparison of the rates of sustained virologic response (SVR) defined as the proportion of patients with loss of serum HCV RNA at week 24 of post-treatment between patient groups (36 vs 48 weeks of treatment period)
At 24 weeks after end of treatment
Secondary Outcomes (3)
the factors associated with sustained virologic response(SVR) between groups
24 weeks after the end of treatment
the rate of end-of-treatment response(EOT)
At the end of treatment (36 or 48 weeks of treatment period)
The relapse rate
At 24 weeks after end of treatment
Study Arms (2)
Pegintron + Riba for 36 wks in total
EXPERIMENTALPegylated 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 for 48 wks in total
ACTIVE COMPARATORPegylated 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)
Interventions
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800\~1400 mg/day
Eligibility Criteria
You may qualify if:
- Aged 20y/o or older
- Positive for the HCV antibody and HCV RNA detected with abnormal ALT (≧ 1X) before initiating PegIFN plus RBV treatment
- HCV Genotype 1
- Have failed to achieve RVR at week 4 but achieve undetectable HCV RNA at week 8 (\< 50 IU/ml) with PegIFN plus RBV treatment
- 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
You may not qualify if:
- Subjects with decompensated liver disease or overt cirrhosis by ultrasound.
- With prior exposures to interferon (standard or pegylated) treatment before baseline.
- With human immunodeficiency virus
- With hepatitis B infection
- With neutrophil count \< 1500 mm3,
- With platelet count \< 90000 mm3,
- With hemoglobin level \< 12g/dL for men or \< 11 g/dL for women
- With serum creatinine level \> 1.5 mg/dL
- With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases
- Female patients with pregnancy or lactation. Pregnancy in partners of male patients.
- Hypersensitive to study drugs cases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chang Gung Memorial Hospitallead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (5)
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Chang Gung Medical Foundation, Kaohsiung Branch
Kaohsiung City, Taiwan
Pingtung Christian Hospital
Pingtung City, 900, Taiwan
Chi Mei Medical Center - Liouying Branch
Tainan, 736, Taiwan
Shin Kong Wu Ho-Su Memorial Hosipital
Taipei, 111, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tsung-Hui Hu, M.D.
Chang Gung Medical Foundation, Kaohsiung Branch
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2012
First Posted
September 12, 2012
Study Start
August 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
September 12, 2012
Record last verified: 2012-09