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NCT01701063 · ClinicalTrials.gov registry record · Phase 1
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 Phase 1 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Terminated
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT01701063: Clinical Trial Phase 1 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT01701063 is a Phase 1 study that was terminated before completion, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01701063, a Phase 1 study, was terminated before completion, sponsored by Vertex Pharmaceuticals Incorporated.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.
Primary Outcome
AE: any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the fo
Interventions
- DRUG Peginterferon alfa-2b
- DRUG Ribavirin
- DRUG Telaprevir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
Why NCT01701063 stopped before completion
NCT01701063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 3 interventions - of which Peginterferon alfa-2b is the first listed.
NCT01701063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01701063 about?
NCT01701063 is a clinical study titled "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". The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.
What is the current status of trial NCT01701063?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2013-01. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01701063?
The interventions under investigation include: Peginterferon alfa-2b (DRUG), Ribavirin (DRUG), Telaprevir (DRUG).
Who is sponsoring clinical trial NCT01701063?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01701063's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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