This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C
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
1 other identifier
interventional
25
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2012
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 6, 2012
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
April 13, 2016
CompletedApril 13, 2016
March 1, 2016
1.5 years
February 6, 2012
January 21, 2016
March 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients With Drug-related Adverse Events
Number of patients with investigator defined drug-related Adverse Events
From first dose of study medication until 30 days after last dose of study medication, up to 199 days
Secondary Outcomes (46)
Percentage of Participants With Virological Response at Week 4
4 weeks
Percentage of Participants With Virological Response at Week 8
8 weeks
Maximum Measured Concentration (Cmax) of Deleobuvir
10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir
10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Area Under the Curve (AUC) of Deleobuvir
10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
- +41 more secondary outcomes
Study Arms (2)
BI 207127 NA, BI 201335 NA(high dose), R
EXPERIMENTALPatients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks
BI 207127 NA,BI 201335 NA(low dose),RBV
EXPERIMENTALPatients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks
Interventions
Eligibility Criteria
You may qualify if:
- Chronic hepatitis C, diagnosed by positive anti-hepatitis C virus(HCV) antibodies and detected HCV ribonucleic acid(RNA) at screening in addition to:
- positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
- liver biopsy consistent with chronic HCV infection.
- HCV infection of genotype 1 confirmed by genotypic testing at screening
- Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
- Plasma HCV RNA = 100,000 IU/mL at screening
You may not qualify if:
- Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
- Human immunodeficiency virus (HIV) co-infection
- Decompensated liver disease, or history of decompensated liver disease
- Body weight \< 40 or \> 125 kg at screening
- Hemoglobin \<12.0g/dL for women and \<13.0g/dL for men at screening
- White blood cell count \<3000 cells/mm3 at screening
- Absolute neutrophil count \< 1,500 cells/mm3 at screening
- Platelet count \< 90,000 /mm3 at screening
- Serum creatinine \> 1.5xUpper Limit of Normal range(ULN) or creatinine clearance =50 mL/min at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
1241.25.002 Boehringer Ingelheim Investigational Site
Kofu, Yamanashi, Japan
1241.25.005 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan
1241.25.003 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1241.25.004 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan
1241.25.001 Boehringer Ingelheim Investigational Site
Omura, Nagasaki, Japan
Related Publications (1)
Yatsuhashi H, Kodani N, Ugai H, Omata M. Open-label phase 2 study of faldaprevir, deleobuvir and ribavirin in Japanese treatment-naive patients with chronic hepatitis C virus genotype 1 infection. Hepatol Res. 2016 Mar;46(3):E189-93. doi: 10.1111/hepr.12535. Epub 2015 Jun 18.
PMID: 25991083DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2012
First Posted
February 8, 2012
Study Start
February 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
April 13, 2016
Results First Posted
April 13, 2016
Record last verified: 2016-03