NCT00905632CompletedPhase 1
Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA Administered in Combination With Peg-IFN and Ribavirin in Chronic HCV-infected Patients for 4 Weeks, a Randomised, Double-blind, Placebo Controlled Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 75
- Locations
- 18
- Primary Endpoint
- Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir.
Study Overview
Brief Summary
The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 207127 low dose + SOC
Experimental
BI 207127 low dose tid + SOC
Intervention: BI 207127 low dose + SOC (Drug)
BI 207127 middle dose +SOC
Experimental
BI 207127 middle dose tid + SOC
Intervention: BI 207127 middle dose +SOC (Drug)
BI 207127 high dose+SOC
Experimental
BI 207127 high dose tid +SOC
Intervention: BI 207127 high dose+SOC (Drug)
Placebo + SOC
Placebo Comparator
Placebo tid +SOC
Intervention: Placebo + SOC (Drug)
Outcomes
Primary Outcomes
Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir.
Time Frame: Baseline and 4 weeks
The primary efficacy endpoint is the number of participants with virologic response defined as \>= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as \>= 1 log increase in viral load from nadir.
Secondary Outcomes
- Number of Participants With Rapid Virological Response(4 weeks)
- Number of Participants With End of Treatment Response(Week 12)
- AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)(30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28)
- Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168(5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27)
- Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline(Baseline and days 1, 2, 4, 8, 15, 22 and 28)
- Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)(5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28)
- AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose(5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28)
- Viral Load at Each Visit up to Day 28(Baseline and days 8, 15, 22 and 28)
- Number of Participants With Early Virological Response(Baseline and week 12)
- Number of Participants With Sustained Virological Response(Until end of treatment, up to 570 days)
- λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose(5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28)
- Number of Participants With Virologic Response at Day 28(day 28)
- Plasma Concentration Time Profiles of BI 207127(0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration)
- Plasma Concentration Time Profiles of CD 6168(0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration)
- C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose(654 hours after drug administration on day 28)
- Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)(5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28)
- t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose(5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28)
- RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose(5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28)
- Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG(From the start of the study to Day 30 (2 days after last dose))
- Number of Participants With Discontinuations Due to AEs(4 weeks)
Investigators
Study Sites (18)
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