4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Hepatitis C, Chronic

Treatments: Drug: BI 207127 high dose+SOC; Drug: BI 207127 low dose + SOC; Drug: BI 207127 middle dose +SOC; Drug: Placebo + SOC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00905632

1241.7

2008-008292-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HCV genotype 1
2. HCV viral load >100,000 IU/mL
3. histology or fibroscan to rule out cirrhosis
4. Absence of retinopathy
5. treatment naive patients and treatment experienced patients
6. Age 18 - 70 years
7. Male OR female with documented hysterectomy OR postmenopausal

Exclusion criteria

1. Fertile males not willing to use an adequate form of contraception
2. Pretreatment with any HCV-polymerase inhibitor
3. Any concurrent disease if clinically significant based on the investigator's medical assessment
4. Current alcohol or drug abuse, or history of the same
5. Positive test for HIV or HBs
6. History of malignancy
7. Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination
8. Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer
9. Any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
10. Patients treated with any interferon (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening
11. Known hypersensitivity to drugs or excipients; Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 4 patient groups, including a placebo group

BI 207127 low dose + SOC

Experimental group

Description:

BI 207127 low dose tid + SOC

Treatment:

Drug: BI 207127 low dose + SOC

BI 207127 middle dose +SOC

Experimental group

Description:

BI 207127 middle dose tid + SOC

Treatment:

Drug: BI 207127 middle dose +SOC

BI 207127 high dose+SOC

Experimental group

Description:

BI 207127 high dose tid +SOC

Treatment:

Drug: BI 207127 high dose+SOC

Placebo + SOC

Placebo Comparator group

Description:

Placebo tid +SOC

Treatment:

Drug: Placebo + SOC