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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701063
• Other study ID #: VX11-950-118
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 27, 2012
• Last updated: May 12, 2015
• Start date: January 2013
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Telaprevir
100- and 250-mg chewable tablets or 375-mg film-coated tablets for oral administration
• 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
• Ribavirin
200-mg capsules or 40-mg/mL solution for oral administration

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated	Janssen Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Growth and development parameters	height, weight, and body mass index[BMI]	Up to 5 years after EOT	No
Other	Quality of life parameters	Child Health Questionnaire [CHQ]	Up to 5 years after EOT	No
Other	Depression parameters	Children's Depression Inventory 2 [CDI 2TM]	Up to 5 years after EOT	No
Primary	Safety parameters, including AEs, study drug modifications or discontinuations, clinical laboratory values, vital signs, and electrocardiogram (ECG) assessments		Up to week 52	Yes
Secondary	Proportion of subjects who achieve undetectable HCV RNA 12 weeks after the last planned dose of study drug (SVR12)		Up to week 60	No
Secondary	Proportion of subjects who achieve undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24)		Up to week 72	No
Secondary	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)		Up to week 48	No
Secondary	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		Up to week 48	No
Secondary	Proportion of subjects with virological relapse, defined as having undetectable HCV RNA at planned EOT followed by detectable HCV RNA after planned EOT		Up to 5 years after EOT	No
Secondary	Part A only, then Part B: Composite of Pharmacokinetics of telaprevir	Observed plasma concentration [Cmax], time to max plasma concentration [tmax], area under the plasma concentration versus time curve [AUC], and [t1/2]	At Day 7, Week 2, Week 4, and Week 8	No
Secondary	Changes from baseline in the amino acid sequence of the HCV NS3•4A protease		Up to week 52	No