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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.
Verified April 2013 by Vertex Pharmaceuticals Incorporated
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01701063
First received: September 27, 2012
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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: May 2017
Estimated Primary Completion Date: October 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701063

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

  Show 30 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
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: April 30, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013