- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02118597
An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients
October 18, 2016 updated by: Hoffmann-La Roche
Non-interventional Study to Observe Triple Combination Therapy With Boceprevir or Simeprevir Plus Peginterferon Alfa-2a Plus Ribavirin for Re-treatment of Chronic Hepatitis C in Hungary (IMPERIAL)
This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection.
Dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling.
Participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Budapest, Hungary, 1125
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Budapest, Hungary, 1097
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Békéscsaba, Hungary, 5600
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Debrecen, Hungary, 4032
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Eger, Hungary, 3300
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Kaposvár, Hungary, 7400
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Szombathely, Hungary, 8800
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with genotype 1 chronic hepatitis C (CHC) infection taking triple combination therapy (boceprevir, peginterferon alfa-2a and ribavirin)
Description
Inclusion Criteria:
- 18 years of age or over
- Genotype 1 CHC infection
- Prior unsuccessful treatment with peginterferon alfa plus ribavirin (null-response, partial response and relapsed participants)
- Receiving triple combination therapy with boceprevir, peginterferon alfa-2a and ribavirin according to standard of care and in line with local labeling
- Enrollment in the study no later than 4 weeks after start of triple combination therapy (including peginterferon alfa-2a and ribavirin lead-in phase)
Exclusion Criteria:
- Naïve participants not responding to peginterferon alfa plus ribavirin at week 4 (HCV RNA drop < 1 log10) or at week 12 (HCV RNA >/= 15 international units/milliliter [IU/mL]) and switching to triple combination therapy with boceprevir
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Triple Combination Therapy
Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.
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Boceprevir administered according to corresponding summary of product characteristics (SmPC).
Other Names:
Simeprevir administered according to corresponding summary of product characteristics (SmPC).
Other Names:
Pegylated interferon (peginterferon) alfa-2a according to corresponding summary of product characteristics (SmPC).
Other Names:
Ribavirin according to corresponding summary of product characteristics (SmPC).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained Virological Response 24 (SVR24) Rate
Time Frame: 24 weeks after end of treatment (EOT) at Week 72
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The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.
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24 weeks after end of treatment (EOT) at Week 72
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Virological Response
Time Frame: Weeks 4, 8, 12, and 24
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Virological response is defined as HCV RNA <15 IU/mL.
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Weeks 4, 8, 12, and 24
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Number of Participants With Virological Breakthrough
Time Frame: Up to Week 48
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Virological breakthrough is defined as either HCV RNA >=15 IU/mL in participants with prior virological response or as an increase in HCV RNA >/=1 log10 above nadir.
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Up to Week 48
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Number of Participants With Virological Relapse
Time Frame: Week 49 up to Week 72
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Virological response is defined as HCV RNA >/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment.
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Week 49 up to Week 72
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Number of Participants With Treatment Discontinuation Due to Futility
Time Frame: Up to Week 48
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Treatment discontinuation due to futility is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.
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Up to Week 48
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Number of Participants With Treatment Discontinuation
Time Frame: Up to Week 48
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Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation.
Futility rule is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.
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Up to Week 48
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Number of Participants With Adverse Events
Time Frame: Up to 72 weeks
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An adverse event 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.
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Up to 72 weeks
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Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate
Time Frame: Screening (before Week 1)
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Demographic characteristics recorded were age and gender.
Predictive value of these characteristics for SVR rate was to be assessed.
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Screening (before Week 1)
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Percentage of Participants With Positive Predictive Value of Liver Fibrosis
Time Frame: Screening (before Week 1)
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The following sub-categories of liver fibrosis were determined in this study: 1) no cirrhosis, 2) bridging fibrosis and 3) cirrhosis.
Predictive value of these sub-categories of liver fibrosis for SVR rate was to be assessed.
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Screening (before Week 1)
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Predictive Value of HCV Disease Characteristics
Time Frame: Screening (before Week 1)
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HCV disease characteristics evaluated were HCV genotype (subtype), including HCV 1(a) and HCV 1(b).
Predictive value of these disease characteristics for SVR rate were to be assessed.
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Screening (before Week 1)
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Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)
Time Frame: Up to 72 weeks
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Previous virological response was sub-categorized into the following categories: null-response, partial response, or relapse.
Predictive value of these sub-categories for SVR rate were to be assessed.
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Up to 72 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
April 16, 2014
First Submitted That Met QC Criteria
April 16, 2014
First Posted (Estimate)
April 21, 2014
Study Record Updates
Last Update Posted (Estimate)
December 12, 2016
Last Update Submitted That Met QC Criteria
October 18, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites
- Antineoplastic Agents
- Protease Inhibitors
- Interferons
- Ribavirin
- Simeprevir
Other Study ID Numbers
- ML29278
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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