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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
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: BI 207127 NA
Drug: peginterferon
Drug: Ribavirin
Drug: BI 201335 NA
 Phase 2

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

Resource links provided by NLM:

Drug Information available for: Ribavirin
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: February 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: peginterferon
per package insert
Drug: Ribavirin
per weight BID
Drug: BI 207127 NA
one fix dose
Drug: BI 201335 NA
high dose
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
 Drug: BI 207127 NA
one fix dose
Drug: Ribavirin
per weight BID
Drug: BI 201335 NA
low dose
Drug: peginterferon
per package insert

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528735

Locations
Japan
1241.25.002 Boehringer Ingelheim Investigational Site
Kofu, Yamanashi, Japan
1241.25.005 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan
1241.25.003 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1241.25.004 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan
1241.25.001 Boehringer Ingelheim Investigational Site
Omura, Nagasaki, Japan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01528735     History of Changes
Other Study ID Numbers: 1241.25
Study First Received: February 6, 2012
Last Updated: May 15, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013