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
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Telaprevir
Drug: Peginterferon alfa-2b
Drug: Ribavirin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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]


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment-Naive or Prior Partial/Null Response
telaprevir + Peginterferon alfa-2b + Ribavirin
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®

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701063

Contacts
Contact: Central Contact Center 617-341-6777 medicalinfo@vrtx.com

  Show 26 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Janssen Pharmaceuticals
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01701063     History of Changes
Other Study ID Numbers: VX11-950-118
Study First Received: September 27, 2012
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2b
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014