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This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01528735
First received: February 6, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes

February 6, 2012
May 15, 2013
February 2012
August 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01528735 on ClinicalTrials.gov Archive Site
  • Virological response at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Virological response at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Virological response at Week 4 [ Time Frame: 4 weeks ]
  • Virological response at Week 8 [ Time Frame: 8 weeks ]
Not Provided
Not Provided
 
This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C
An Open-label, Ascending Dose, Phase II Study to Evaluate Tolerability, Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA in Combination With BI 201335 NA and Ribavirin for 8 Weeks in Treatment-naïve Japanese Patients With Genotype 1chronic Hepatitis C Virus Infection

The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: BI 207127 NA
    one fix dose
  • Drug: peginterferon
    per package insert
  • Drug: Ribavirin
    per weight BID
  • Drug: BI 201335 NA
    high dose
  • Drug: BI 201335 NA
    low dose
  • Experimental: BI 207127 NA, BI 201335 NA(high dose), R
    Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks
    Interventions:
    • Drug: peginterferon
    • Drug: Ribavirin
    • Drug: BI 207127 NA
    • Drug: BI 201335 NA
  • Experimental: BI 207127 NA,BI 201335 NA(low dose),RBV
    Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks
    Interventions:
    • Drug: BI 207127 NA
    • Drug: Ribavirin
    • Drug: BI 201335 NA
    • Drug: peginterferon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Chronic hepatitis C, diagnosed by positive anti-hepatitis C virus(HCV) antibodies and detected HCV ribonucleic acid(RNA) at screening in addition to:

    1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
    2. liver biopsy consistent with chronic HCV infection.
  • HCV infection of genotype 1 confirmed by genotypic testing at screening
  • Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
  • Plasma HCV RNA = 100,000 IU/mL at screening

Exclusion criteria:

  • Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
  • Human immunodeficiency virus (HIV) co-infection
  • Decompensated liver disease, or history of decompensated liver disease
  • Body weight < 40 or > 125 kg at screening
  • Hemoglobin <12.0g/dL for women and <13.0g/dL for men at screening
  • White blood cell count <3000 cells/mm3 at screening
  • Absolute neutrophil count < 1,500 cells/mm3 at screening
  • Platelet count < 90,000 /mm3 at screening
  • Serum creatinine > 1.5xUpper Limit of Normal range(ULN) or creatinine clearance =50 mL/min at screening
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01528735
1241.25
Not Provided
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP