Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)
NCT ID: NCT01297270
Last Updated: 2015-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
658 participants
INTERVENTIONAL
2011-04-30
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PegIFN/RBV
48 weeks
PegIFN/RBV
BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
PegIFN/RBV
BI201335
QD (once daily) BI 201335
BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
BI201335
QD BI 201335
PegIFN/RBV
Placebo
Placebo
Interventions
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BI201335
QD BI 201335
PegIFN/RBV
BI201335
QD (once daily) BI 201335
Placebo
Eligibility Criteria
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Inclusion Criteria
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.
2. HCV genotype 1 infection confirmed by genotypic testing at screening.
3. Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
4. HCV RNA = 1,000 IU/mL at screening
5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months of the screening visit.
Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before enrolment need not be repeated. Biopsies can be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy should not exclude patients from a trial.
6. Age 18 to 70 years
7. Female patients:
(c) with documented hysterectomy, (d) who have had both ovaries removed, (e) with documented tubal ligation, (f) who are post-menopausal with last menstrual period at least 12 months prior to screening, or (g) of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, 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 in addition to the consistent and correct use of a condom. Patients must agree not to 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 ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance and intra-uterine device.
Male patients:
1. who are documented to be sterile, or
2. who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) 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. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase.
8. Signed informed consent form prior to trial participation
Exclusion Criteria
2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection.
3. HIV co-infection.
4. Hepatitis B virus (HBV) infection based on presence of HBs-Ag.
5. Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
6. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
7. A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient¿s ability to participate in this study.
8. Usage of any investigational drugs within 28 days prior to screening, or planned usage of an investigational drug during the course of this study.
9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 28 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened.
10. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to screening and throughout the treatment phase.
11. Known hypersensitivity to any ingredient of the study drugs.
12. Alpha fetoprotein value \>100 ng/mL at screening; if \>20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2).
13. Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory results of any of the following:
1. International normalized ratio (INR) of =1.7
2. Serum Albumin =3.5 g/dL
3. Serum total bilirubin =2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilberts syndrome).
14. Pre-existing psychiatric condition that could interfere with the subject¿s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years.
18 Years
70 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1220.47.0004 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1220.47.0045 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1220.47.0050 Boehringer Ingelheim Investigational Site
Dothan, Alabama, United States
1220.47.0061 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1220.47.0091 Boehringer Ingelheim Investigational Site
North Little Rock, Arkansas, United States
1220.47.0008 Boehringer Ingelheim Investigational Site
Bakersfield, California, United States
1220.47.0019 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
1220.47.0010 Boehringer Ingelheim Investigational Site
Coronado, California, United States
1220.47.0033 Boehringer Ingelheim Investigational Site
La Jolla, California, United States
1220.47.0035 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
1220.47.0011 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1220.47.0014 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1220.47.0100 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1220.47.0018 Boehringer Ingelheim Investigational Site
Oceanside, California, United States
1220.47.0059 Boehringer Ingelheim Investigational Site
Poway, California, United States
1220.47.0024 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1220.47.0037 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1220.47.0031 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
1220.47.0082 Boehringer Ingelheim Investigational Site
Englewood, Colorado, United States
1220.47.0049 Boehringer Ingelheim Investigational Site
New Haven, Connecticut, United States
1220.47.0057 Boehringer Ingelheim Investigational Site
Bradenton, Florida, United States
1220.47.0078 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1220.47.0086 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1220.47.0054 Boehringer Ingelheim Investigational Site
Hialeah, Florida, United States
1220.47.0088 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1220.47.0044 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1220.47.0099 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1220.47.0095 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida, United States
1220.47.0074 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1220.47.0022 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
1220.47.0039 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
1220.47.0052 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
1220.47.0013 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1220.47.0055 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1220.47.0062 Boehringer Ingelheim Investigational Site
Vaiparaiso, Indiana, United States
1220.47.0085 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
1220.47.0087 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
1220.47.0101 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
1220.47.0064 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
1220.47.0069 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
1220.47.0067 Boehringer Ingelheim Investigational Site
Chevy Chase, Maryland, United States
1220.47.0079 Boehringer Ingelheim Investigational Site
Lutherville, Maryland, United States
1220.47.0027 Boehringer Ingelheim Investigational Site
Framingham, Massachusetts, United States
1220.47.0065 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
1220.47.0023 Boehringer Ingelheim Investigational Site
Tulepo, Mississippi, United States
1220.47.0046 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
1220.47.0066 Boehringer Ingelheim Investigational Site
Neptune City, New Jersey, United States
1220.47.0083 Boehringer Ingelheim Investigational Site
Brooklyn, New York, United States
1220.47.0003 Boehringer Ingelheim Investigational Site
New York, New York, United States
1220.47.0006 Boehringer Ingelheim Investigational Site
New York, New York, United States
1220.47.0038 Boehringer Ingelheim Investigational Site
New York, New York, United States
1220.47.0090 Boehringer Ingelheim Investigational Site
New York, New York, United States
1220.47.0097 Boehringer Ingelheim Investigational Site
The Bronx, New York, United States
1220.47.0053 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1220.47.0021 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
1220.47.0098 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
1220.47.0028 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
1220.47.0058 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
1220.47.0030 Boehringer Ingelheim Investigational Site
Germantown, Tennessee, United States
1220.47.0072 Boehringer Ingelheim Investigational Site
Jackson, Tennessee, United States
1220.47.0032 Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
1220.47.0041 Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
1220.47.0063 Boehringer Ingelheim Investigational Site
Arlington, Texas, United States
1220.47.0029 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1220.47.0017 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1220.47.0056 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1220.47.0071 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1220.47.0060 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
1220.47.0081 Boehringer Ingelheim Investigational Site
Forth Worth, Texas, United States
1220.47.0009 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1220.47.0068 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1220.47.0016 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1220.47.0015 Boehringer Ingelheim Investigational Site
Burlington, Vermont, United States
1220.47.0042 Boehringer Ingelheim Investigational Site
Annandale, Virginia, United States
1220.47.0043 Boehringer Ingelheim Investigational Site
Falls Church, Virginia, United States
1220.47.0026 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1220.47.0092 Boehringer Ingelheim Investigational Site
Seattle, Washington, United States
1220.47.0073 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin, United States
1220.47.1011 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1220.47.1012 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
1220.47.1001 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1220.47.1003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1220.47.1016 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1220.47.1007 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
1220.47.1009 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
1220.47.1013 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1220.47.1002 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
1220.47.1004 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
1220.47.1005 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1220.47.1006 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1220.47.1015 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1220.47.1010 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1220.47.1014 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1220.47.0034 Boehringer Ingelheim Investigational Site
San Juan, , Puerto Rico
1220.47.8204 Boehringer Ingelheim Investigational Site
Pusan, , South Korea
1220.47.8205 Boehringer Ingelheim Investigational Site
Pusan, , South Korea
1220.47.8203 Boehringer Ingelheim Investigational Site
Seongnam, , South Korea
1220.47.8202 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1220.47.8206 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1220.47.8207 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1220.47.8201 Boehringer Ingelheim Investigational Site
Yangsan, , South Korea
1220.47.8803 Boehringer Ingelheim Investigational Site
Kaohsiung City, , Taiwan
1220.47.8804 Boehringer Ingelheim Investigational Site
Kaohsiung City, , Taiwan
1220.47.8802 Boehringer Ingelheim Investigational Site
Taichung, , Taiwan
1220.47.8801 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1220.47.8805 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
Countries
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References
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Jensen DM, Asselah T, Dieterich D, Foster GR, Sulkowski MS, Zeuzem S, Mantry P, Yoshida EM, Moreno C, Ouzan D, Wright M, Morano LE, Buynak R, Bourliere M, Hassanein T, Nishiguchi S, Kao JH, Omata M, Paik SW, Wong DK, Tam E, Kaita K, Feinman SV, Stern JO, Scherer J, Quinson AM, Voss F, Gallivan JP, Bocher WO, Ferenci P. Faldaprevir, pegylated interferon, and ribavirin for treatment-naive HCV genotype-1: pooled analysis of two phase 3 trials. Ann Hepatol. 2016 May-Jun;15(3):333-49. doi: 10.5604/16652681.1198803.
Other Identifiers
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2010-021716-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1220.47
Identifier Type: -
Identifier Source: org_study_id
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