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NCT00793793 · ClinicalTrials.gov registry record · Phase 1
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
A Phase 1 study of Hepatitis C, Chronic, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 16
- Study locations
NCT00793793 is a Phase 1 study of Hepatitis C, Chronic that has completed, run by Boehringer Ingelheim. The registered enrollment target is 96 participants, below the 372-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (74% lower). The trial reports 16 study locations across 5 states.
The verdict
NCT00793793, a Phase 1 study of Hepatitis C, Chronic, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 16
- Study locations
Study Summary
This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients. A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BI201335
Study Locations (16)
Other
- 1220.2.3304A Boehringer Ingelheim Investigational Site - Lyon
- 1220.2.3303A Boehringer Ingelheim Investigational Site - Marseille
- 1220.2.3301A Boehringer Ingelheim Investigational Site - Paris
- 1220.2.3302A Boehringer Ingelheim Investigational Site - Paris
- 1220.2.49002 Boehringer Ingelheim Investigational Site - Berlin
- 1220.2.49005 Boehringer Ingelheim Investigational Site - Düsseldorf
- 1220.2.49006 Boehringer Ingelheim Investigational Site - Hanover
- 1220.2.49004 Boehringer Ingelheim Investigational Site - Kiel
- 1220.2.49003 Boehringer Ingelheim Investigational Site - Mainz
- 1220.2.34001 Boehringer Ingelheim Investigational Site - Madrid
California
- 1220.2.10 Boehringer Ingelheim Investigational Site - San Francisco
- 1220.2.15 Boehringer Ingelheim Investigational Site - San Francisco
New York
- 1220.2.11 Boehringer Ingelheim Investigational Site - New York
- 1220.2.12 Boehringer Ingelheim Investigational Site - New York
Maryland
- 1220.2.17 Boehringer Ingelheim Investigational Site - Baltimore
Texas
- 1220.2.14 Boehringer Ingelheim Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-01-25 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00793793
The ClinicalTrials.gov registry entry for NCT00793793 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 372-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (74% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00793793 reports 16 study locations spanning 5 distinct geographic areas - top geographies include Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT00793793 about?
NCT00793793 is a clinical study titled "Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced". This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 2...
What is the current status of trial NCT00793793?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2007-09. Estimated completion is 2011-01-25.
What conditions does trial NCT00793793 study?
This clinical trial studies the following conditions: Hepatitis C, Chronic.
What interventions are being tested in trial NCT00793793?
The interventions under investigation include: Placebo (DRUG), BI201335 (DRUG).
Who is sponsoring clinical trial NCT00793793?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00793793 being conducted?
This trial has 16 study locations across California, Maryland, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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