Status:
COMPLETED
4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 lo...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- HCV genotype 1
- HCV viral load \>100,000 IU/mL
- histology or fibroscan to rule out cirrhosis
- Absence of retinopathy
- treatment naive patients and treatment experienced patients
- Age 18 - 70 years
- Male OR female with documented hysterectomy OR postmenopausal
- Exclusion criteria:
- Fertile males not willing to use an adequate form of contraception
- Pretreatment with any HCV-polymerase inhibitor
- Any concurrent disease if clinically significant based on the investigator's medical assessment
- Current alcohol or drug abuse, or history of the same
- Positive test for HIV or HBs
- History of malignancy
- Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination
- Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer
- Any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
- Patients treated with any interferon (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening
- Known hypersensitivity to drugs or excipients; Further exclusion criteria apply
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00905632
Start Date
May 1 2009
Last Update
April 19 2016
Active Locations (18)
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1
1241.7.3307A CHU de Grenoble
Grenoble Cédex 9, France
2
1241.7.3303A Hôpital Claude Huriez
Lille, France
3
1241.7.3302A Hopital de l'Hotel Dieu
Lyon, France
4
1241.7.3301A Hôpital Saint Eloi
Montpellier, France