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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905632
• Other study ID #: 1241.7
• Secondary ID: 2008-008292-34
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2009
• Last updated: November 21, 2014
• Start date: May 2009

Study information

• Verified date: November 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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 load and how safe BI 207127 is in this combination in HCV infected patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C, Chronic

Intervention

Drug:
• BI 207127 middle dose +SOC
BI 207127 middle dose tid + SOC
• BI 207127 high dose+SOC
BI 207127 high dose tid +SOC
• Placebo + SOC
Placebo tid +SOC
• BI 207127 low dose + SOC
BI 207127 low dose tid + SOC

Locations

Country	Name	City	State
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
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
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

France,  Germany,  Switzerland, 

Outcome

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