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COMPLETED Phase 1

Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced

NCT00793793 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 96 participants
Start Date 2007-09
Est. Completion 2011-01-25
Phase Phase 1

Sponsor

Boehringer Ingelheim

203 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00793793 reports 16 study locations spanning 5 distinct geographic areas — top geographies include Other, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00793793?

The interventions under investigation include: Placebo (DRUG), BI201335 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00793793?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial