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

NCT ID: NCT00905632

Last Updated: 2016-04-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 207127 low dose + SOC

BI 207127 low dose tid + SOC

Group Type EXPERIMENTAL

BI 207127 low dose + SOC

Intervention Type DRUG

BI 207127 low dose tid + SOC

BI 207127 middle dose +SOC

BI 207127 middle dose tid + SOC

Group Type EXPERIMENTAL

BI 207127 middle dose +SOC

Intervention Type DRUG

BI 207127 middle dose tid + SOC

BI 207127 high dose+SOC

BI 207127 high dose tid +SOC

Group Type EXPERIMENTAL

BI 207127 high dose+SOC

Intervention Type DRUG

BI 207127 high dose tid +SOC

Placebo + SOC

Placebo tid +SOC

Group Type PLACEBO_COMPARATOR

Placebo + SOC

Intervention Type DRUG

Placebo tid +SOC

Interventions

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BI 207127 middle dose +SOC

BI 207127 middle dose tid + SOC

Intervention Type DRUG

BI 207127 high dose+SOC

BI 207127 high dose tid +SOC

Intervention Type DRUG

Placebo + SOC

Placebo tid +SOC

Intervention Type DRUG

BI 207127 low dose + SOC

BI 207127 low dose tid + SOC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1241.7.3307A CHU de Grenoble

Grenoble Cédex 9, , France

Site Status

1241.7.3303A Hôpital Claude Huriez

Lille, , France

Site Status

1241.7.3302A Hopital de l'Hotel Dieu

Lyon, , France

Site Status

1241.7.3301A Hôpital Saint Eloi

Montpellier, , France

Site Status

1241.7.3305A HOP Archet 2

Nice, , France

Site Status

1241.7.3306A Hôpital Haut-Lévêque

Pessac, , France

Site Status

1241.7.3304A HOP de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

1241.7.49010 Boehringer Ingelheim Investigational Site

Aachen, , Germany

Site Status

1241.7.49012 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1241.7.49004 Boehringer Ingelheim Investigational Site

Essen, , Germany

Site Status

1241.7.49011 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

Site Status

1241.7.49001 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1241.7.49013 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1241.7.49009 Boehringer Ingelheim Investigational Site

Regensburg, , Germany

Site Status

1241.7.49002 Boehringer Ingelheim Investigational Site

Ulm, , Germany

Site Status

1241.7.41003 Boehringer Ingelheim Investigational Site

Basel, , Switzerland

Site Status

1241.7.41004 Boehringer Ingelheim Investigational Site

Lugano, , Switzerland

Site Status

1241.7.41001 Boehringer Ingelheim Investigational Site

Sankt Gallen, , Switzerland

Site Status

Countries

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France Germany Switzerland

References

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Larrey D, Lohse AW, de Ledinghen V, Trepo C, Gerlach T, Zarski JP, Tran A, Mathurin P, Thimme R, Arasteh K, Trautwein C, Cerny A, Dikopoulos N, Schuchmann M, Heim MH, Gerken G, Stern JO, Wu K, Abdallah N, Girlich B, Scherer J, Berger F, Marquis M, Kukolj G, Bocher W, Steffgen J. Rapid and strong antiviral activity of the non-nucleosidic NS5B polymerase inhibitor BI 207127 in combination with peginterferon alfa 2a and ribavirin. J Hepatol. 2012 Jul;57(1):39-46. doi: 10.1016/j.jhep.2012.02.015. Epub 2012 Mar 10.

Reference Type DERIVED
PMID: 22414766 (View on PubMed)

Other Identifiers

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2008-008292-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1241.7

Identifier Type: -

Identifier Source: org_study_id

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