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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 is a Phase 1 study that was terminated before completion, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 42 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01701063
The ClinicalTrials.gov registry entry for NCT01701063 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Peginterferon alfa-2b is the first listed.
NCT01701063 reports 0 study locations.
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.
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