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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00382798
The ClinicalTrials.gov registry entry for NCT00382798 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharmasset, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RO5024048 is the first listed.
NCT00382798 reports 0 study locations.
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.
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