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Trial record 12 of 16 for:    IU/mL | BI 201335 OR faldaprevir

IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

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ClinicalTrials.gov Identifier: NCT01732796
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : April 18, 2016
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Ribavirin (RBV) Drug: BI 201335 (Faldaprevir) Drug: BI 207127 Drug: Faldaprevir (BI 201335) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection
Study Start Date : December 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: Allocated 24 weeks BI 207127 + BI 201335
24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
Drug: Ribavirin (RBV)
24 weeks of active RBV

Drug: BI 201335 (Faldaprevir)
24 weeks of BI 201335

Drug: BI 207127
24 weeks of BI 207127

Experimental: Randomized 16 weeks BI 7127+BI1335 + RBV
16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
Drug: BI 201335 (Faldaprevir)
16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335

Drug: Ribavirin (RBV)
16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin

Drug: BI 207127
16 weeks BI 207127 followed by 8 weeks placebo to BI 207127

Experimental: Randomized 24weeks BI 7127+ BI1335 + RBV
24 weeks of BI 207127and BI 201335 in combination with RBV
Drug: Ribavirin (RBV)
24 weeks of active RBV

Drug: BI 207127
24 weeks of BI 207127

Drug: Faldaprevir (BI 201335)
24 weeks of 201335




Primary Outcome Measures :
  1. SVR12 Rates With Historical Control [ Time Frame: 12 Week (post-treatment) ]
    Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level <25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint

  2. Comparisons of SVR12 Rates Across Treatment Arms [ Time Frame: 12 Week (post-treatment) ]
    Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.


Secondary Outcome Measures :
  1. SVR4 [ Time Frame: 4 Week (post-treatment) ]
    Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).

  2. SVR24 [ Time Frame: 24 Week (post-treatment) ]
    Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Chronic hepatitis C infection, diagnosed by positive HCV Ab or detectable HCV RNA at screening in addition to at least one of the following:

    1. positive HCV RNA or HCV antibodies at least 6 months prior to screening, or
    2. liver biopsy typical of chronic hepatitis C , or
    3. history of elevated ALT at least 6 months prior to screening.
  • HCV infection of sub-GT1b confirmed by genotypic testing at screening
  • Treatment naïve defined as:

    1. no prior treatment with any interferon, pegylated interferon, and /or ribavirin and
    2. no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection
  • Plasma HCV RNA > or = 1,000 IU/mL at screening
  • Liver biopsy within three years or fibroscan within six months prior to randomization. Patients with compensated liver cirrhosis (score Child-Pugh A) could also be included.
  • Age 18 to 75 years
  • Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to randomization

    1. with documented hysterectomy, or
    2. who have had both ovaries removed, or
    3. with documented tubal ligation, or
    4. who are post-menopausal with last menstrual period at least 12 months prior to screening, or
    5. of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (Visit 2), that agree to use two non-hormonal methods of birth control from the date of screening until months after the last dose of ribavirin. They must not breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Medically accepted methods of contraception for females in this trial are diaphragm with spermicide substance, intrauterine devices, cervical caps and condoms.

OR:

Male patients

  1. who are documented to be sterile, or
  2. who consistently and correctly use a condom while their female partners (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin, and
  3. without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and follow-up phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).

Exclusion criteria:

  • HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
  • HCV subtype 1a, mixed 1a/1b or GT1 undefined
  • Evidence of liver disease mainly due to causes other than chronic HCV infection such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease
  • HIV-1 or HIV-2 infection
  • Hepatitis B virus (HBV) infection based on presence of HBs-Ag
  • Evidence of decompensated liver disease, or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, or bleeding esophageal varices,
  • International Normalized Ratio (INR) > or =1.7
  • Serum albumin < 3.3 g/dL
  • Serum total bilirubin >2.0 times the upper limit of normal (ULN) with direct/indirect ratio >1, unless history of Gilbert's disease
  • Active or suspected malignancy or history of malignancy within the last 5 years (with the exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
  • Patients with ongoing or historical photosensitivity or recurrent rash

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732796


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Locations
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United States, Alabama
1241.20.00026 Boehringer Ingelheim Investigational Site
Dothan, Alabama, United States
United States, California
1241.20.00033 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
1241.20.00006 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
1241.20.00003 Boehringer Ingelheim Investigational Site
Oceanside, California, United States
1241.20.00008 Boehringer Ingelheim Investigational Site
Poway, California, United States
United States, Florida
1241.20.00015 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1241.20.00014 Boehringer Ingelheim Investigational Site
Fort Pierce, Florida, United States
1241.20.00004 Boehringer Ingelheim Investigational Site
Maitland, Florida, United States
United States, Georgia
1241.20.00010 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
United States, Louisiana
1241.20.00001 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
United States, Maryland
1241.20.00018 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
1241.20.00002 Boehringer Ingelheim Investigational Site
Chevy Chase, Maryland, United States
United States, Massachusetts
1241.20.00032 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
United States, Nevada
1241.20.00009 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
United States, New York
1241.20.00016 Boehringer Ingelheim Investigational Site
New York, New York, United States
1241.20.00031 Boehringer Ingelheim Investigational Site
New York, New York, United States
1241.20.00019 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
United States, Oklahoma
1241.20.00024 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
United States, Oregon
1241.20.00013 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Texas
1241.20.00005 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1241.20.00017 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1241.20.00012 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1241.20.00022 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
United States, Virginia
1241.20.00020 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
Austria
1241.20.43003 Boehringer Ingelheim Investigational Site
Graz, Austria
Canada, British Columbia
1241.20.01001 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1241.20.01008 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1241.20.01010 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1241.20.01003 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
Canada, Ontario
1241.20.01006 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1241.20.01002 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1241.20.01005 Boehringer Ingelheim Investigational Site
Whitby, Ontario, Canada
Canada, Quebec
1241.20.01007 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
France
1241.20.33003 Boehringer Ingelheim Investigational Site
Clermont-Ferrand Cedex, France
1241.20.33004 Boehringer Ingelheim Investigational Site
Lyon, France
1241.20.33006 Boehringer Ingelheim Investigational Site
Marseille Cedex 08, France
1241.20.33001 Boehringer Ingelheim Investigational Site
Montpellier Cedex 5, France
1241.20.33005 Boehringer Ingelheim Investigational Site
Nice Cedex 3, France
1241.20.33007 Boehringer Ingelheim Investigational Site
Paris, France
1241.20.33002 Boehringer Ingelheim Investigational Site
Pessac Cedex, France
1241.20.33009 Boehringer Ingelheim Investigational Site
Rennes Cedex 09, France
1241.20.33008 Boehringer Ingelheim Investigational Site
Vandoeuvre Cedex, France
Germany
1241.20.49002 Boehringer Ingelheim Investigational Site
Berlin, Germany
1241.20.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
1241.20.49012 Boehringer Ingelheim Investigational Site
Bonn, Germany
1241.20.49001 Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
1241.20.49014 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1241.20.49009 Boehringer Ingelheim Investigational Site
Herne, Germany
1241.20.49008 Boehringer Ingelheim Investigational Site
Kiel, Germany
1241.20.49013 Boehringer Ingelheim Investigational Site
Köln, Germany
1241.20.49011 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1241.20.49006 Boehringer Ingelheim Investigational Site
Magdeburg, Germany
1241.20.49003 Boehringer Ingelheim Investigational Site
München, Germany
1241.20.49010 Boehringer Ingelheim Investigational Site
Oberhausen, Germany
1241.20.49005 Boehringer Ingelheim Investigational Site
Ulm, Germany
1241.20.49007 Boehringer Ingelheim Investigational Site
Würzburg, Germany
Hungary
1241.20.36001 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1241.20.36002 Boehringer Ingelheim Investigational Site
Kaposvar, Hungary
Ireland
1241.20.35303 Boehringer Ingelheim Investigational Site
Dublin 8, Ireland
1241.20.35301 Boehringer Ingelheim Investigational Site
Dublin, Ireland
1241.20.35302 Boehringer Ingelheim Investigational Site
Dublin, Ireland
Italy
1241.20.39007 Boehringer Ingelheim Investigational Site
Ancona, Italy
1241.20.39003 Boehringer Ingelheim Investigational Site
Brescia, Italy
1241.20.39002 Boehringer Ingelheim Investigational Site
Milano, Italy
1241.20.39008 Boehringer Ingelheim Investigational Site
Milano, Italy
1241.20.39006 Boehringer Ingelheim Investigational Site
Napoli, Italy
1241.20.39005 Boehringer Ingelheim Investigational Site
Pavia, Italy
1241.20.39001 Boehringer Ingelheim Investigational Site
Torino, Italy
1241.20.39004 Boehringer Ingelheim Investigational Site
Torino, Italy
Netherlands
1241.20.31001 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1241.20.31003 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1241.20.31004 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1241.20.31006 Boehringer Ingelheim Investigational Site
Den Haag, Netherlands
1241.20.31005 Boehringer Ingelheim Investigational Site
Groningen, Netherlands
Portugal
1241.20.35103 Boehringer Ingelheim Investigational Site
Aveiro, Portugal
1241.20.35104 Boehringer Ingelheim Investigational Site
Coimbra, Portugal
1241.20.35101 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1241.20.35102 Boehringer Ingelheim Investigational Site
Porto, Portugal
1241.20.35105 Boehringer Ingelheim Investigational Site
Vila Real, Portugal
Romania
1241.20.40001 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1241.20.40002 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1241.20.40003 Boehringer Ingelheim Investigational Site
Bucharest, Romania
Russian Federation
1241.20.70002 Boehringer Ingelheim Investigational Site
Chelyabinsk, Russian Federation
1241.20.70001 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1241.20.70004 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1241.20.70005 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Spain
1241.20.34007 Boehringer Ingelheim Investigational Site
A Coruña, Spain
1241.20.34004 Boehringer Ingelheim Investigational Site
Alicante, Spain
1241.20.34002 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1241.20.34005 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1241.20.34003 Boehringer Ingelheim Investigational Site
Madrid, Spain
1241.20.34001 Boehringer Ingelheim Investigational Site
Majadahonda, Madrid, Spain
1241.20.34008 Boehringer Ingelheim Investigational Site
Santander, Spain
1241.20.34006 Boehringer Ingelheim Investigational Site
Valencia, Spain
United Kingdom
1241.20.44005 Boehringer Ingelheim Investigational Site
Bristol, United Kingdom
1241.20.44007 Boehringer Ingelheim Investigational Site
Liverpool, United Kingdom
1241.20.44001 Boehringer Ingelheim Investigational Site
London, United Kingdom
1241.20.44002 Boehringer Ingelheim Investigational Site
London, United Kingdom
1241.20.44006 Boehringer Ingelheim Investigational Site
London, United Kingdom
1241.20.44004 Boehringer Ingelheim Investigational Site
Nottingham, United Kingdom
1241.20.44003 Boehringer Ingelheim Investigational Site
Southampton, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01732796     History of Changes
Other Study ID Numbers: 1241.20
2012-003533-41 ( EudraCT Number: EudraCT )
First Posted: November 26, 2012    Key Record Dates
Results First Posted: April 18, 2016
Last Update Posted: April 18, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents