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

NCT02118597 | Terminated Results

• 1 other identifier: ML29278
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 7

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Sustained Virological Response 24 (SVR24) Rate

  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.

  24 weeks after end of treatment (EOT) at Week 72

Secondary Outcomes (10)

• Percentage of Participants With Virological Response

  Weeks 4, 8, 12, and 24

• Number of Participants With Virological Breakthrough

  Up to Week 48

• Number of Participants With Virological Relapse

  Week 49 up to Week 72

• Number of Participants With Treatment Discontinuation Due to Futility

  Up to Week 48

• Number of Participants With Treatment Discontinuation

  Up to Week 48

Study Arms (1)

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.

Drug: Boceprevir; Drug: Simeprevir; Drug: Pegylated Interferon (Peginterferon) Alfa-2a; Drug: Ribavirin

Interventions

Boceprevir DRUG

Boceprevir administered according to corresponding summary of product characteristics (SmPC).

Also known as: Victrelis

Triple Combination Therapy

Simeprevir DRUG

Simeprevir administered according to corresponding summary of product characteristics (SmPC).

Also known as: Olysio

Triple Combination Therapy

Pegylated Interferon (Peginterferon) Alfa-2a DRUG

Pegylated interferon (peginterferon) alfa-2a according to corresponding summary of product characteristics (SmPC).

Also known as: Pegasys

Triple Combination Therapy

Ribavirin DRUG

Ribavirin according to corresponding summary of product characteristics (SmPC).

Also known as: Copegus

Triple Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Unknown Facility

Békéscsaba, 5600, Hungary

Location

Unknown Facility

Budapest, 1097, Hungary

Location

Unknown Facility

Budapest, 1125, Hungary

Location

Unknown Facility

Debrecen, 4032, Hungary

Location

Unknown Facility

Eger, 3300, Hungary

Location

Unknown Facility

Kaposvár, 7400, Hungary

Location

Unknown Facility

Szombathely, 8800, Hungary

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum used to analyze levels of hepatitic c virus (HCV) ribonucleic acid (RNA)

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; Simeprevir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 12, 2016
• Results First Posted: December 12, 2016

Record last verified: 2016-10

Locations

HU (7)