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NCT00087607 · ClinicalTrials.gov registry record · Phase 4
Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 385
- Enrollment target
NCT00087607: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00087607 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 385 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00087607, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 385 participants
- Enrollment target
Study Summary
This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Primary Outcome
The viral load was determined quantitatively and qualitatively by Hepatitis C virus (HCV)-polymerase chain reaction (PCR). HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 international units per milliliter (U/mL), changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10
Interventions
- DRUG Ribavirin
- DRUG Peginterferon alfa-2a [Pegasys]
- DRUG Peginterferon alfa-2b (PEG-Intron)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 385 participants |
| Start Date | 2004-01 |
| Est. Completion | 2006-04 |
| Phase | Phase 4 |
What the finished NCT00087607 record still lists
NCT00087607 is an interventional study that assigns participants to a tested intervention. The registered 385 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT00087607 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00087607 about?
NCT00087607 is a clinical study titled "Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).". This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
What is the current status of trial NCT00087607?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 385 participants. The study started on 2004-01. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00087607?
The interventions under investigation include: Ribavirin (DRUG), Peginterferon alfa-2a [Pegasys] (DRUG), Peginterferon alfa-2b (PEG-Intron) (DRUG).
Who is sponsoring clinical trial NCT00087607?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00087607's enrollment target sits among peer trials
385 222nd of 2000 higher than 1,779 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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