An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Pegasys and Ribivarin in the Re-Treatment of Chronic Hepatitis C Patients

Hepatitis C, Chronic Clinical Trial

Official title:

Non-interventional Study to Observe Triple Combination Therapy With Boceprevir Plus Peginterferon Alfa-2a Plus Ribavirin for Re-treatment of Chronic Hepatitis C in Hungary

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02118597
• Other study ID #: ML29278
• Status: Not yet recruiting
• Phase: N/A
• First received: April 16, 2014
• Last updated: April 16, 2014
• Start date: May 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2014
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: ML29278 www.roche.com/about_roche/roc
• Phone: 888-662-6728 (U.S. Only)
• Email: global.rochegenentechtrials[@]roche.com
• Is FDA regulated: No
• Health authority: Hungary: Gyogyszereszeti és Egeszsegugyi Minoseg- es Szervezetfejlesztesi Intezet Orszagos Gyogyszereszeti Intezet
• Study type: Observational

Clinical Trial Summary

This prospective, national, multicenter, non-interventional study will examine the use of triple combination therapy with boceprevir, Pegasys and ribivarin in re-treating patients with genotype 1 CHC infection. Dosing and treatment duration are at the discretion of the investigator in accordance with local clinical practice and local labeling. Patients will be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or over

• Genotype 1 CHC infection

• Prior unsuccessful treatment with Peginterferon plus ribivarin (null-response, partial response and relapsed patients)

• Receiving triple combination therapy with boceprevir, Pegasys and ribivarin according to standard of care and in line with local labeling

• Enrolment in the study no later than 4 weeks after start of triple combination therapy (including Pegasys and ribivarin lead-in phase)

• Given consent to take part in the study

Exclusion Criteria:

• Naïve patients not responding to Peginterferon plus ribivarin at week 4 (HCV RNA drop < 1 log10) or at week 12 (HCV RNA >/= 15 IU/mL) and switching to triple combination therapy with boceprevir

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response 24 (SVR24), defined as percentage of patients with HCV RNA < 15 IU/mL after the 24-week follow-up		At Week 72	No
Secondary	Virological response (HCV RNA < 15 IU/mL)		Weeks 4, 8, 12, 24, and 48	No
Secondary	Virological breakthrough, defined as either HCV RNA >/= 15 IU/mL in patients with prior virological response or as an increase in RCV RNA >/= 1 log10 above nadir		Up to Week 48	No
Secondary	Virological relapse defined as HCV RNA >/= 15 IU/mL during the treatment free follow-up period in patients with virological response at the end of treatment		Weeks 49 to 72	No
Secondary	Incidence of treatment discontinuation due to futility, 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		Up to Week 48	No
Secondary	Incidence of treatment discontinuation		Up to Week 48	No
Secondary	Incidence of adverse events		72 weeks	No
Secondary	Predictive value of patient demographics		Screening (before Week 1)	No
Secondary	Predictive value of liver fibrosis		Screening (before Week 1)	No
Secondary	Predictive value of HCV disease characteristics		Screening (before Week 1)	No
Secondary	Predictive value of previous virological response (null-response, partial response, or relapse)		Up to 72 weeks	No