At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
BI 207127 NA +7 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.
An Open-label, Ascending Dose, Phase II Study to Evaluate Tolerability, Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA in Combination With BI 201335 NA and Ribavirin for 8 Weeks in Treatment-naïve Japanese Patients With Genotype 1chronic Hepatitis C Virus Infection
In Brief
A Phase 2 clinical trial evaluating BI 207127 NA, peginterferon, and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 25 participants across 5 sites.
Detailed Summary
The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedFeb 2012
Primary CompletionAug 2013
TodayJul 2026
First PostedFeb 8, 2012
Enrollment StartFeb 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.4 years ago
Interventions
BI 207127 NAdrug
one fix dose
peginterferondrug
per package insert
Ribavirindrug
per weight BID
Ribavirindrug
per weight BID
BI 207127 NAdrug
one fix dose
BI 201335 NAdrug
high dose
BI 201335 NAdrug
low dose
peginterferondrug
per package insert