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NCT00266318 · ClinicalTrials.gov registry record · Phase 4
Study of High Dosage CIFN Plus RBV for HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Therapy
A Phase 4 study, sponsored by Beth Israel Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT00266318 is a Phase 4 study that has completed, run by Beth Israel Medical Center. The registered enrollment target is 40 participants.
The verdict
NCT00266318, a Phase 4 study, has completed, sponsored by Beth Israel Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the safety and tolerability of combination therapy of daily interferon alfacon-1 (Infergen, CIFN) at high dosage (24 mcg) with ribavirin (based on body weight) for 48 weeks in HCV genotype 1 infected subjects, who are non-responders to previous pegylated interferon alfa plus ribavirin therapy. This is an open-label, multicenter study. All subjects will receive Infergen 24 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body weight) administered by mouth daily for 48 weeks \* If any 5 of the first 10 subjects can not tolerate the 24 mcg daily dosage of Infergen by week 4, as determined by the principal investigator, then the dosage of Infergen will be changed to 15 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body weight) administered by mouth daily for 48 weeks
Interventions
- DRUG Interferon Alfacon-1 and Ribavirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-12 |
| Est. Completion | 2007-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00266318
The ClinicalTrials.gov registry entry for NCT00266318 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Medical Center, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Interferon Alfacon-1 and Ribavirin is the first listed.
NCT00266318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00266318 about?
NCT00266318 is a clinical study titled "Study of High Dosage CIFN Plus RBV for HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Therapy". The main purpose of this study is to evaluate the safety and tolerability of combination therapy of daily interferon alfacon-1 (Infergen, CIFN) at high dosage (24 mcg) with ribavirin (based on body weight) for 48 weeks in HCV genotype 1 infected subjects, who are non-responders to previous pegylated...
What is the current status of trial NCT00266318?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2005-12. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00266318?
The interventions under investigation include: Interferon Alfacon-1 and Ribavirin (DRUG).
Who is sponsoring clinical trial NCT00266318?
This trial is sponsored by Beth Israel Medical Center, which has 44 total clinical trials registered on ClinicalTrials.gov.
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