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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00905632
First received: May 19, 2009
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peg-IFN and RBV on HCV virus load and how safe BI 207127 is in this combination in HCV infected patients.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: BI 207127 middle dose +SOC
Drug: BI 207127 high dose+SOC
Drug: Placebo + SOC
Drug: BI 207127 low dose + SOC
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary efficacy endpoint is 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: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • early virological response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • end of treatment response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • sustained virological response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration time profiles of BI 207127 and CD 6168 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • rapid virological response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Safety (vital signs, adverse events, safety laboratory tests, ECG) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Viral load (Log10) at each visit up to day 28, both actual and change from baseline [ Time Frame: Baseline up to day 28 ] [ Designated as safety issue: No ]
  • Virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ) at day 28 [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • Cmax of first day of BI 207127 and CD 6168 [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Tmax of first day of BI 207127 and CD 6168 [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • AUC0-6 of first day of BI 207127 and CD 6168 [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Cpre,1 of first day of BI 207127 and CD 6168 [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Cpre,2 of first day of BI 207127 and CD 6168 [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Cpre Pharmacokinetic parameter of BI 207127 and CD 6168 [ Time Frame: days 2, 4, 8, 15, 22 and 27 ] [ Designated as safety issue: No ]
  • Cmax,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • Tmax,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • AUC0-6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • AUC0-infinity,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • λz Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • t1/2,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • MRTpo,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • RA,Cmax Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • Number of patients with changes in Vital signs (pulse rate, systolic and diastolic blood pressure) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with changes in body temperature [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with changes in electrocardiogram (ECG) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with changes in safety laboratory test [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Incidence and Intensity of Adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with Discontinuations due to AEs [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with changes in Physical examination [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Global Assessment of tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: May 2009
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 207127 low dose + SOC
BI 207127 low dose tid + SOC
Drug: BI 207127 low dose + SOC
BI 207127 low dose tid + SOC
Experimental: BI 207127 middle dose +SOC
BI 207127 middle dose tid + SOC
Drug: BI 207127 middle dose +SOC
BI 207127 middle dose tid + SOC
Experimental: BI 207127 high dose+SOC
BI 207127 high dose tid +SOC
Drug: BI 207127 high dose+SOC
BI 207127 high dose tid +SOC
Placebo Comparator: Placebo + SOC
Placebo tid +SOC
Drug: Placebo + SOC
Placebo tid +SOC

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905632

Locations
France
1241.7.3307A CHU de Grenoble
Grenoble cédex 9, France
1241.7.3303A Hôpital Claude Huriez
Lille, France
1241.7.3302A Hopital de l'Hotel Dieu
Lyon cedex 02, France
1241.7.3301A Hôpital Saint Eloi
Montpellier, France
1241.7.3305A HOP Archet 2
Nice Cedex 3, France
1241.7.3306A Hôpital Haut-Lévêque
Pessac Cedex, France
1241.7.3304A HOP de Brabois
Vandoeuvre, France
Germany
1241.7.49010 Boehringer Ingelheim Investigational Site
Aachen, Germany
1241.7.49012 Boehringer Ingelheim Investigational Site
Berlin, Germany
1241.7.49004 Boehringer Ingelheim Investigational Site
Essen, Germany
1241.7.49011 Boehringer Ingelheim Investigational Site
Freiburg, Germany
1241.7.49001 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1241.7.49013 Boehringer Ingelheim Investigational Site
Mainz, Germany
1241.7.49009 Boehringer Ingelheim Investigational Site
Regensburg, Germany
1241.7.49002 Boehringer Ingelheim Investigational Site
Ulm, Germany
Switzerland
1241.7.41003 Boehringer Ingelheim Investigational Site
Basel, Switzerland
1241.7.41004 Boehringer Ingelheim Investigational Site
Lugano, Switzerland
1241.7.41001 Boehringer Ingelheim Investigational Site
St. Gallen, Switzerland
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00905632     History of Changes
Other Study ID Numbers: 1241.7, 2008-008292-34
Study First Received: May 19, 2009
Last Updated: October 31, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

ClinicalTrials.gov processed this record on October 01, 2014