An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Vertex Pharmaceuticals Incorporated
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01701063
First received: September 27, 2012
Last updated: August 7, 2014
Last verified: March 2014

September 27, 2012
August 7, 2014
January 2013
August 2016   (final data collection date for primary outcome measure)
Safety parameters, including AEs, study drug modifications or discontinuations, clinical laboratory values, vital signs, and electrocardiogram (ECG) assessments [ Time Frame: Up to week 52 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01701063 on ClinicalTrials.gov Archive Site
  • Proportion of subjects who achieve undetectable HCV RNA 12 weeks after the last planned dose of study drug (SVR12) [ Time Frame: Up to week 60 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) [ Time Frame: Up to week 72 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve undetectable HCV RNA at Week 4, at Week 12, at both Weeks 4 and 12 (eRVR), and at the planned end of treatment (EOT) [ Time Frame: Up to week 48 ] [ Designated as safety issue: No ]
  • Proportion of subjects with on-treatment virologic failure, defined as either meeting a futility rule or completing the assigned treatment duration with detectable HCV RNA at the EOT [ Time Frame: Up to week 48 ] [ Designated as safety issue: No ]
  • Proportion of subjects with virological relapse, defined as having undetectable HCV RNA at planned EOT followed by detectable HCV RNA after planned EOT [ Time Frame: Up to 5 years after EOT ] [ Designated as safety issue: No ]
  • Part A only, then Part B: Composite of Pharmacokinetics of telaprevir [ Time Frame: At Day 7, Week 2, Week 4, and Week 8 ] [ Designated as safety issue: No ]
    Observed plasma concentration [Cmax], time to max plasma concentration [tmax], area under the plasma concentration versus time curve [AUC], and [t1/2]
  • Changes from baseline in the amino acid sequence of the HCV NS3•4A protease [ Time Frame: Up to week 52 ] [ Designated as safety issue: No ]
Same as current
  • Growth and development parameters [ Time Frame: Up to 5 years after EOT ] [ Designated as safety issue: No ]
    height, weight, and body mass index[BMI]
  • Quality of life parameters [ Time Frame: Up to 5 years after EOT ] [ Designated as safety issue: No ]
    Child Health Questionnaire [CHQ]
  • Depression parameters [ Time Frame: Up to 5 years after EOT ] [ Designated as safety issue: No ]
    Children's Depression Inventory 2 [CDI 2TM]
Same as current
 
An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus
A Two-Part, Open-Label, Single-Arm Phase 1/2 Study of Safety, Pharmacokinetics, and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Aged 3 to 17 Infected With Genotype 1 Hepatitis C Virus

The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with HCV on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
  • Drug: Telaprevir
    100- and 250-mg chewable tablets or 375-mg film-coated tablets for oral administration
  • Drug: Peginterferon alfa-2b
    50 μg/0.5 mL, 80 μg/0.5 mL, 120 μg/0.5 mL, or 150 μg/0.5 mL for subcutaneous (SC) injection
    Other Name: PegIntron®
  • Drug: Ribavirin
    200-mg capsules or 40-mg/mL solution for oral administration
    Other Name: Rebetol®
Experimental: Treatment-Naive or Prior Partial/Null Response
telaprevir + Peginterferon alfa-2b + Ribavirin
Interventions:
  • Drug: Telaprevir
  • Drug: Peginterferon alfa-2b
  • Drug: Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
August 2016
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or females ages 3 to 17 years of age
  • Chronic hepatitis C
  • Hepatitis C virus genotype 1a or b at the Screening Visit
  • Subject is judged to be in good health (besides HCV infection) in the opinion of the investigator.
  • Signed ICF, and where appropriate, signed Assent Form

Exclusion Criteria:

  • History of or prior evidence of a medical condition associated with chronic liver disease other than HCV
  • Body weight <15 kg or >90 kg
  • Prior evidence of hepatic decompensation
  • Contraindications to Peg-IFN/RBV
  • History or other evidence of severe retinopathy or clinically significant ophthalmological disorder
  • History of non-genotype 1 HCV
  • Participation in investigational drug study as described in Study Protocol
  • Use of prohibited drugs within 7 days or 5 half-lives before the first dose of study drug
Both
3 Years to 17 Years
No
Contact: Central Contact Center 617-341-6777 medicalinfo@vrtx.com
United States,   Belgium,   Germany,   Italy,   Spain,   United Kingdom
 
NCT01701063
VX11-950-118
Yes
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Janssen Pharmaceuticals
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP