NCT01585584

Brief Summary

The purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 21, 2015

Completed
Last Updated

September 21, 2015

Status Verified

August 1, 2015

Enrollment Period

2.6 years

First QC Date

April 18, 2012

Results QC Date

August 22, 2015

Last Update Submit

August 22, 2015

Conditions

Hepatitis C

Keywords

BoceprevirHepatitis C Genotype 3

Outcome Measures

Primary Outcomes (1)

  • Sustained Virologic Response (SVR) at 24 Weeks Post Treatment

    Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.

    24 weeks after treatment

Study Arms (1)

Boceprevir

EXPERIMENTAL
Drug: Boceprevir

Interventions

BoceprevirDRUG

All patients will receive a 4-week lead-in with Peginterferon and Ribavirin therapy, followed by 24 weeks of Pegetron 1.5microg/kg + weight-based ribavirin + boceprevir 800mg tid. HCV RNA (Cobas TaqMan) will be measured at baseline and at treatment weeks 4, 6,8,12,16,20,24 and 28, and post-treatment weeks 12 and 24 (to obtain SVR-12 and SVR-24 results).

Also known as: VICTRELIS™, boceprevir capsules, 200 mg, Hepatitis C Virus (HCV) Protease Inhibitor
Boceprevir

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Infected with HCV genotype 3 (mixed genotypes are NOT permitted)
  • Have received at least 12 weeks of previous treatment with peginterferon-α + ribavirin
  • Detectable serum HCV-RNA
  • No significant co-morbid conditions
  • Liver biopsy is not necessary
  • Cirrhotic patients will be eligible to participate if Child-Pugh class A (maximum 15% of subjects)

You may not qualify if:

  • Subjects will be excluded from participation in this study if the following conditions are present:
  • Significant comorbidities: uncontrolled psychiatric conditions including severe depression, cardiovascular, respiratory, renal or metabolic conditions, active carcinoma.
  • Active substance abuse within the past 12 months
  • Co-infection with hepatitis B or HIV
  • Decompensated cirrhosis (Child-Pugh class B or C)
  • Significant cytopenia - any of the following: platelets \<80 x 109/L, neutropenia \<1.2 x 103/L, Hb \<120 g/l for men or 110 g/l for women
  • Lack of informed consent
  • Previous null-responders (\<2 log10 decrease at week 12 with previous PR therapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary Liver Unit

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Hepatitis C

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-carboxamideProtease Inhibitors

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Limitations and Caveats

Small sample size (n=11)

Results Point of Contact

Title
Dr. Samuel Lee
Organization
University of Calgary
samlee@ucalgary.ca
403-220-8457

Study Officials

  • Samuel Lee, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hepatologist

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 26, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2014

Study Completion

July 1, 2015

Last Updated

September 21, 2015

Results First Posted

September 21, 2015

Record last verified: 2015-08

Locations

CA(1)