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NCT00382798 · ClinicalTrials.gov registry record · Phase 1
Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin
A Phase 1 study, sponsored by Pharmasset.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT00382798: Completed Phase 1 study, sponsored by Pharmasset.
NCT00382798 is a Phase 1 study that has completed, run by Pharmasset. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00382798, a Phase 1 study, has completed, sponsored by Pharmasset.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is an adaptive Phase I study to evaluate RO5024048 in the following groups: * Healthy Volunteers (Part 1 - Single Ascending Dose Study) -Enrollment completed * Hepatitis C virus (HCV) genotype 1 infected patients who have failed interferon therapy (Part 2- Multiple Ascending Dose Study)-Enrollment Completed * HCV genotype 1-infected patients who are treatment naive, to be dosed in combination with PEG-IFN and RBV (Part 3 - Combination Dose Study)-Currently Enrolling * HCV genotype 2-3 infected patients who have previously been treated with interferon but who did not respond, to be dosed in combination with PEG-IFN and RBV (Part 3 - Combination Dose Study)- Currently enrolling The study aims to determine if RO5024048 is safe and well-tolerated in healthy people and in people infected with hepatitis C virus. The amount of RO5024048 in the blood will be measured during the study and the amount of hepatitis C virus in the blood after each dose will also be measured. During Part 3 of the study, RO5024048 will be given with PEG-IFN and RBV, two drugs currently used and approved for the treatment of HCV.
Interventions
- DRUG RO5024048
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2006-10 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
What the finished NCT00382798 record still lists
NCT00382798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 1 intervention - of which RO5024048 is the first listed.
NCT00382798 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00382798 about?
NCT00382798 is a clinical study titled "Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin". This is an adaptive Phase I study to evaluate RO5024048 in the following groups: * Healthy Volunteers (Part 1 - Single Ascending Dose Study) -Enrollment completed * Hepatitis C virus (HCV) genotype 1 infected patients who have failed interferon therapy (Part 2- Multiple Ascending Dose Study)-Enroll...
What is the current status of trial NCT00382798?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2006-10. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00382798?
The interventions under investigation include: RO5024048 (DRUG).
Who is sponsoring clinical trial NCT00382798?
This trial is sponsored by Pharmasset, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00382798's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 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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