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NCT00627926 · ClinicalTrials.gov registry record · Phase 3

A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
1,095
Enrollment target

NCT00627926: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

NCT00627926 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 1,095 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00627926, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
1,095 participants
Enrollment target

Study Summary

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

Primary Outcome

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidan

Interventions

  • OTHER Placebo
  • DRUG Ribavirin
  • DRUG Telaprevir
  • BIOLOGICAL Pegylated Interferon Alfa 2a

Trial Details

FieldValue
Enrollment Target 1,095 participants
Start Date 2008-03
Est. Completion 2010-05
Phase Phase 3
Vertex Pharmaceuticals Incorporated

191 total trials

What the finished NCT00627926 record still lists

NCT00627926 is an interventional study that assigns participants to a tested intervention. Its 1,095 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00627926 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00627926 about?

NCT00627926 is a clinical study titled "A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)". A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

What is the current status of trial NCT00627926?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,095 participants. The study started on 2008-03. Estimated completion is 2010-05.

What interventions are being tested in trial NCT00627926?

The interventions under investigation include: Placebo (OTHER), Ribavirin (DRUG), Telaprevir (DRUG), Pegylated Interferon Alfa 2a (BIOLOGICAL).

Who is sponsoring clinical trial NCT00627926?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00627926's enrollment target sits among peer trials

1,095 265th of 2000 higher than 1,735 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00627926, the US trial registry maintained by the National Library of Medicine. NCT00627926 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.