A Study of Peginterferon Alfa-2a Plus Ribavirin in Early Non-Responder Participants With Chronic Hepatitis C (CHC) Genotype 1, 4, 5, and 6
An Open-label Pilot Study of Dose Escalation of PEGASYS on Virological Response in Patients With Chronic Hepatitis C Viral Infection Showing an Early Non-response to a Standard Course of PEGASYS Plus Ribavirin
2 other identifiers
interventional
23
1 country
21
Brief Summary
This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6 CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin. The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24 weeks).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2005
Typical duration for phase_3
21 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
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 6, 2016
CompletedJune 8, 2016
June 1, 2016
3 years
May 31, 2016
June 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Virologic Response, as measured by ultrasensitive Roche HCV TaqMan Test
Week 12
Secondary Outcomes (4)
Percentage of Participants Achieving Sustained Virologic Response (SVR), as measured by ultrasensitive Roche HCV TaqMan Test
Week 56
Percentage of Participants Achieving End-of-treatment Response, as measured by ultrasensitive Roche HCV TaqMan Test
Week 32
Mean Log Change From Baseline to Week 2, 4, 8, 12, 32, and 56 in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Viral Load
Baseline, Week 2, 4, 8, 12, 32, 56
Number of Participants With Adverse Events and Serious Adverse
Baseline up to Week 56
Study Arms (1)
Peginterferon Alfa-2a + Ribavirin
EXPERIMENTALParticipants will receive 360 microgram (mcg) of Peginterferon Alfa-2a subcutaneous (SC) once a week plus ribavirin (1000 - 1200 milligram per day \[mg/day\] orally as a split dose in the morning and the evening based on the participant's body weight) for 32 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Participants with serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Participants had to have been receiving their first treatment for chronic hepatitis C (i.e. previously naive to any therapy) consisting of peginterferon alfa-2a plus ribavirin for 16 weeks (+/- 10 days), without reaching a negative or 2-log drop of Serum Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at Week 12 of therapy as compared to pretreatment value, and must still be on therapy (no wash out)
- HCV-RNA quantifiable by a test reporting in international units
- Compensated liver disease (Child-Pugh Grade A clinical classification)
- Participants with cirrhosis or transition to cirrhosis had to have an abdominal ultrasound, computerized tomography (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma and a serum alpha fetoprotein (AFP) less than (\<)100 nanogram pe milliliter (ng/mL) within 6 months of study entry
- Negative urine or blood pregnancy test
- Participants had to be using two forms of effective contraception during treatment and during the 6 months after treatment end
- Able to participate and to comply with the study restrictions
You may not qualify if:
- Women with ongoing pregnancy or who are breast feeding and male partners of women who were pregnant
- Neutrophil count \<1,500 cells/cubic millimeter (mm\^3) or platelet count \<90,000 cells/mm\^3 before initiation of the ongoing treatment regimen; or neutrophil count \<750 cells/mm\^3 or platelet count \<50,000 cells/mm\^3 at screening while still on therapy with peginterferon alfa-2a plus ribavirin
- Hemoglobin (Hgb) \<12 gram per deciliter (g/dL) before initiation of the ongoing treatment regimen; or Hgb \<10 g/dL at screening while still on therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
- Serum creatinine level greater than (\>)1.5 times the upper limit of normal at screening
- Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) other than the currently failing Pegasys plus ribavirin combination therapy less than or equal to (\<=) 6 months prior to the first dose of study drug
- Positive test for hepatitis A immunoglobulin M (IgM) antibody (anti-HAV IgM Ab), hepatitis B surface antigen (HBsAg), anti-hepatitis B core IgM antibody (anti-HBc IgM Ab), anti-Human Immunodeficiency Virus antibody (anti-HIV Ab)
- History or other evidence of a medical condition associated with chronic liver disease other than HCV
- History of bleeding from esophageal varices or other conditions consistent with decompensated liver disease, severe psychiatric disease (especially depression), severe seizure disorder, thyroid disease, immunologically mediated disease, chronic pulmonary disease, cardiac disease, major organ transplantation or other evidence of severe illness, malignancy
- Evidence of drug abuse including excessive alcohol consumption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Antwerp, 2018, Belgium
Unknown Facility
Antwerp, 2060, Belgium
Unknown Facility
Bruges, 8000, Belgium
Unknown Facility
Brussels, 1000, Belgium
Unknown Facility
Brussels, 1020, Belgium
Unknown Facility
Brussels, 1070, Belgium
Unknown Facility
Brussels, 1090, Belgium
Unknown Facility
Brussels, 1180, Belgium
Unknown Facility
Brussels, 1190, Belgium
Unknown Facility
Brussels, 1200, Belgium
Unknown Facility
Charleroi, 6000, Belgium
Unknown Facility
Edegem, 2650, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Gilly, 6060, Belgium
Unknown Facility
Haine-Saint-Paul, 7100, Belgium
Unknown Facility
Kortrijk, 8500, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Namur, 5000, Belgium
Unknown Facility
Roeselare, 8800, Belgium
Unknown Facility
Yvoir, 5530, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 6, 2016
Study Start
June 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
June 8, 2016
Record last verified: 2016-06