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NCT00800735 · ClinicalTrials.gov registry record · Phase 3
A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT00800735 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 30 participants.
The verdict
NCT00800735, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus, 800-1200 mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48 weeks in genotype G1 with a treatment-free follow up period of 24 weeks.
Interventions
- DRUG Ribavirin
- DRUG Pegylated-interferon alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-04 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00800735
The ClinicalTrials.gov registry entry for NCT00800735 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ribavirin is the first listed.
NCT00800735 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00800735 about?
NCT00800735 is a clinical study titled "A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols". This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised o...
What is the current status of trial NCT00800735?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2009-04. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00800735?
The interventions under investigation include: Ribavirin (DRUG), Pegylated-interferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT00800735?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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