Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00793793 |
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 |
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) |
Estimated Enrollment: | 264 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Contact: Boehringer Ingelheim Study Coordinator | 800-542-6257 ext Option 4 | clintriage.rdg@boehringer-ingelheim.com |
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 |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
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 |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Interferons |
Ribavirin Peginterferon alfa-2a Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action |
Flaviviridae Infections Therapeutic Uses Antiviral Agents Pharmacologic Actions |