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NCT00774397 · ClinicalTrials.gov registry record · Phase 2
Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 719
- Enrollment target
NCT00774397 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 719 participants.
The verdict
NCT00774397, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 719 participants
- Enrollment target
Study Summary
The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.
Interventions
- DRUG PegIFN/RBV
- DRUG BI 201335 NA 240 mg QD / LI
- DRUG BI 201335 NA 120mg QD / LI
- DRUG BI 201335 NA 240 mg QD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 719 participants |
| Start Date | 2008-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00774397
The ClinicalTrials.gov registry entry for NCT00774397 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 719 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which PegIFN/RBV is the first listed.
NCT00774397 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00774397 about?
NCT00774397 is a clinical study titled "Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)". The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ...
What is the current status of trial NCT00774397?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 719 participants. The study started on 2008-10.
What interventions are being tested in trial NCT00774397?
The interventions under investigation include: PegIFN/RBV (DRUG), BI 201335 NA 240 mg QD / LI (DRUG), BI 201335 NA 120mg QD / LI (DRUG), BI 201335 NA 240 mg QD (DRUG).
Who is sponsoring clinical trial NCT00774397?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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