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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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)

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sustained Virological Response 24 (SVR24) Rate
timeFrame: 24 weeks after end of treatment (EOT) at Week 72
Secondary outcomes:
measure: Percentage of Participants With Virological Response
timeFrame: Weeks 4, 8, 12, and 24
measure: Number of Participants With Virological Breakthrough
timeFrame: Up to Week 48
measure: Number of Participants With Virological Relapse
timeFrame: Week 49 up to Week 72
measure: Number of Participants With Treatment Discontinuation Due to Futility
timeFrame: Up to Week 48
measure: Number of Participants With Treatment Discontinuation
timeFrame: Up to Week 48
measure: Number of Participants With Adverse Events
timeFrame: Up to 72 weeks
measure: Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate
timeFrame: Screening (before Week 1)
measure: Percentage of Participants With Positive Predictive Value of Liver Fibrosis
timeFrame: Screening (before Week 1)
measure: Predictive Value of HCV Disease Characteristics
timeFrame: Screening (before Week 1)
measure: Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)
timeFrame: Up to 72 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Békéscsaba
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
city: Kaposvár
country: Hungary
city: Szombathely
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: