CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 75 enrolled
Drug / intervention
BI 207127 NA +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02176525
NCT02176525Phase 1Completed
CompareCT.gov

Safety, Antiviral Activity, and Pharmacokinetics of Multiple Oral Doses of BI 207127 NA Administered q8H for 5 Days as Monotherapy, a Randomised, Double-blind, Placebo Controlled Study

Boehringer Ingelheim·interventional·Posted Jun 27, 2014·Updated Jun 6, 2016

In Brief

A Phase 1 clinical trial evaluating BI 207127 NA and Placebo for Hepatitis C, Chronic. Completed, enrolled 75 participants.

Detailed Summary

The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both treatment-naïve patients and patients previously treated with peginterferon and ribavirin were included. In addition, the effect of study medication was examined in a group of patients with liver cirrhosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 27, 2014
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.0 years ago

Interventions

BI 207127 NAdrug

Placebodrug