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Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, December 2008
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00793793
  Purpose

This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.

A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: BI 201335
Drug: Peginterferon alfa-2a (Pegasys)
Drug: Ribavirin (Copegus)
Phase I

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy Study
Official Title: Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-Blind, Placebo Controlled), and in Treatment-Experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-Label)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Efficacy: VR of >=2 log10 reduction in HCV RNA from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients) Safety: occurrence of AEs, SAEs, and lab abnormalities [ Time Frame: 28 Days ]

Secondary Outcome Measures:
  • Efficacy: RVR, EVR, SVR Pharmacokinetic: plasma concentration and drug drug interaction [ Time Frame: 72 Weeks ]

Estimated Enrollment: 264
Study Start Date: September 2007
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1a. For treatment-naïve patients: no prior therapy with interferon, peginterferon, or ribavirin for acute or chronic hepatitis C infection

1b. For treatment-experienced patients: confirmed virological failure during or after combination treatment with an approved dose of alfa-2a or alfa-2b peginterferon combined with ribavirin; such patients must have received at least 12 weeks of therapy with a 90 day washout period prior to screening and must have documentation of medical history prior to enrolment in 1220.2 2. Age 18 years or older 3. Signed informed consent form prior to trial participation 4. Male or female with documented hysterectomy or menopausal female with last menstrual period at least 6 months prior to screening 5. Chronic hepatitis C infection of genotype 1, diagnosed by positive HCV serology test (HCV Ab positive) or detectable HCV RNA at least 6 months prior to screening 6. HCV viral load >= 100,000 IU/mL at screening 7. TSH and T4 within normal limits or adequately controlled thyroid function 8. Histological evidence within 36 months prior to study enrolment of any degree of chronic necroinflammatory activity or the presence of fibrosis (Ishak Grade 1-4 or Metavir Grade 1-3)

Exclusion Criteria:

  1. Patients who have been previously treated with at least one dose of any protease inhibitor for acute or chronic hepatitis C infection
  2. Evidence of liver disease due to causes other than chronic HCV infection
  3. Positive ELISA for HIV-1 or HIV-2
  4. Hepatitis B virus (HBV) infection based on presence of Hbs Ag or HBV DNA
  5. Any previous liver biopsy consistent with cirrhosis
  6. Decompensated liver diseases as evidenced by ascites, portal hypertension, jaundice or hepatic encephalopathy
  7. Haemophilia
  8. Hemoglobinopathy (e.g., thalassemia major or sickle cell anemia)
  9. Severe pre-existing psychiatric disease
  10. Poorly controlled diabetes mellitus
  11. Ischaemic heart disease
  12. Chronic obstructive airway disease
  13. Autoimmune disease; including autoimmune hepatitis
  14. History of alcohol abuse within the past 12 months
  15. Hyperbilirubinemia (conjugated bilirubin) >1.5x ULN
  16. Alkaline phosphatase >1.5x ULN
  17. ALT and AST levels >= 5 x ULN
  18. Hemoglobin < 12.0 g/dL for women and < 13.0 g/dL for men
  19. White blood cell count < 2000 cells/mm3
  20. Absolute Neutrophil Count < 1500 cells/mm3
  21. Platelet count < 100,000 cells/mm3
  22. Prothrombin time INR (Institutional Normalized Ratio) prolonged to > 1.5 x ULN
  23. Usage of any investigational drug within 30 days prior to enrolment; or the planned usage of an investigational drug during the course of the current study
  24. Known hypersensitivity to study drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793793

Contacts
Contact: Boehringer Ingelheim Study Coordinator 800-542-6257 ext Option 4 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, California
1220.2.10 Boehringer Ingelheim Investigational Site Recruiting
San Francisco, California, United States
1220.2.15 Boehringer Ingelheim Investigational Site Recruiting
San Francisco, California, United States
United States, Florida
1220.2.13 Boehringer Ingelheim Investigational Site Not yet recruiting
Miami, Florida, United States
United States, Illinois
1220.2.16 Boehringer Ingelheim Investigational Site Not yet recruiting
Chicago, Illinois, United States
United States, Maryland
1220.2.17 Boehringer Ingelheim Investigational Site Recruiting
Baltimore, Maryland, United States
United States, New York
1220.2.11 Boehringer Ingelheim Investigational Site Recruiting
New York, New York, United States
1220.2.12 Boehringer Ingelheim Investigational Site Recruiting
New York, New York, United States
United States, Texas
1220.2.14 Boehringer Ingelheim Investigational Site Recruiting
Austin, Texas, United States
France
1220.2.3301A Boehringer Ingelheim Investigational Site Recruiting
Paris, France
1220.2.3302A Boehringer Ingelheim Investigational Site Recruiting
Paris, France
1220.2.3303A Boehringer Ingelheim Investigational Site Recruiting
Marseille, France
1220.2.3304A Boehringer Ingelheim Investigational Site Recruiting
Lyon, France
Germany
1220.2.49001 Boehringer Ingelheim Investigational Site Recruiting
Freiburg, Germany
1220.2.49002 Boehringer Ingelheim Investigational Site Recruiting
Berlin, Germany
1220.2.49003 Boehringer Ingelheim Investigational Site Recruiting
Mainz, Germany
1220.2.49004 Boehringer Ingelheim Investigational Site Completed
Kiel, Germany
1220.2.49005 Boehringer Ingelheim Investigational Site Recruiting
Düsseldorf, Germany
1220.2.49006 Boehringer Ingelheim Investigational Site Recruiting
Hannover, Germany
Spain
1220.2.34001 Boehringer Ingelheim Investigational Site Recruiting
Madrid, Spain
1220.2.34002 Boehringer Ingelheim Investigational Site Not yet recruiting
Barcelona, Spain
1220.2.34003 Boehringer Ingelheim Investigational Site Recruiting
Madrid, Spain
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1220.2
Study First Received: September 23, 2008
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00793793  
Health Authority: France: AFSSAPS;   Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medical Devices);   Spain: Spanish Agency for Medicines and Health Products;   United States: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Peginterferon alfa-2a
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009