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History of Changes for Study: NCT01297270
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)
Latest version (submitted August 18, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 15, 2011 None (earliest Version on record)
2 February 17, 2011 Study Identification and Study Status
3 April 26, 2011 Recruitment Status, Study Status, Eligibility, Outcome Measures, Contacts/Locations and Oversight
4 May 4, 2011 Contacts/Locations, Arms and Interventions and Study Status
5 June 1, 2011 Contacts/Locations and Study Status
6 June 28, 2011 Contacts/Locations and Study Status
7 July 27, 2011 Contacts/Locations, Study Status and Study Identification
8 August 23, 2011 Contacts/Locations and Study Status
9 September 21, 2011 Sponsor/Collaborators, Study Status and Contacts/Locations
10 October 19, 2011 Study Status and Contacts/Locations
11 November 16, 2011 Contacts/Locations and Study Status
12 December 14, 2011 Contacts/Locations and Study Status
13 January 11, 2012 Recruitment Status, Study Status and Contacts/Locations
14 February 8, 2012 Contacts/Locations and Study Status
15 March 6, 2012 Study Status
16 March 7, 2012 Study Status
17 April 4, 2012 Study Status
18 May 2, 2012 Study Status
19 May 30, 2012 Study Status
20 June 27, 2012 Study Status
21 July 25, 2012 Study Status
22 August 22, 2012 Study Status
23 September 21, 2012 Study Status and Study Identification
24 October 17, 2012 Study Status
25 November 14, 2012 Study Status
26 December 13, 2012 Study Status
27 January 9, 2013 Study Status
28 January 15, 2013 Contacts/Locations and Study Status
29 February 6, 2013 Study Status and Study Identification
30 March 6, 2013 Study Status
31 March 20, 2013 Study Status
32 April 3, 2013 Study Status
33 April 17, 2013 Study Status
34 April 30, 2013 Study Status
35 May 15, 2013 Study Status
36 June 12, 2013 Contacts/Locations and Study Status
37 June 26, 2013 Outcome Measures and Study Status
38 July 10, 2013 Study Status
39 July 24, 2013 Study Status
40 August 7, 2013 Study Status
41 September 4, 2013 Study Status
42 October 9, 2013 Study Status
43 October 16, 2013 Contacts/Locations and Study Status
44 October 30, 2013 Study Status
45 November 13, 2013 Study Status
46 November 27, 2013 Study Status
47 December 10, 2013 Study Status
48 December 17, 2013 Study Status
49 January 8, 2014 Study Status and Study Design
50 January 22, 2014 Study Status
51 February 5, 2014 Study Status
52 February 19, 2014 Study Status
53 March 5, 2014 Study Status
54 March 19, 2014 Study Status
55 April 2, 2014 Study Status
56 April 16, 2014 Recruitment Status, Study Status and Study Design
57 May 6, 2014 Study Status
58 January 23, 2015 Outcome Measures, Arms and Interventions, Study Status and Study Design
59 August 18, 2015 Outcome Measures, Study Status, More Information, Arms and Interventions, Adverse Events, Baseline Characteristics and Participant Flow
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Study NCT01297270
Submitted Date:  July 24, 2013 (v39)

Open or close this module Study Identification
Unique Protocol ID: 1220.47
Brief Title: 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)
Official Title: A Phase III, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.
Secondary IDs: 2010-021716-42 [EudraCT Number: EudraCT]
Open or close this module Study Status
Record Verification: July 2013
Overall Status: Active, not recruiting
Study Start: April 2011
Primary Completion: April 2014 [Anticipated]
Study Completion: April 2014 [Anticipated]
First Submitted: February 15, 2011
First Submitted that
Met QC Criteria:
February 15, 2011
First Posted: February 16, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 24, 2013
Last Update Posted: July 25, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Boehringer Ingelheim
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.
Detailed Description:
Open or close this module Conditions
Conditions: Hepatitis C
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 625 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: PegIFN/RBV
48 weeks standard of care
Drug: PegIFN/RBV
Experimental: BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
Drug: BI201335
QD (once daily) BI 201335
Experimental: BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
Drug: BI201335
QD BI 201335
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Sustained virological respeonse 12 weeks post treatment (SVR12): Plasma HCV level<25 IU/mL, undetected 12 weeks after the originally planned treatment duration.
[ Time Frame: 36 weeks ]

Secondary Outcome Measures:
1. 8. Virological response after 24weeks of treatment discontinuation (SVR24): - Plasma HCV RNA level < 25 IU/mL, undetected 24weeks after the originally planned treatment duration.
[ Time Frame: 48 weeks ]

2. 9. Early Treatment Success (ETS): - Plasma HCV RNA level < 25 IU/mL (detected or undetected) at Week 4 and HCV RNA < 25 IU/mL, undetected at Week 8.
[ Time Frame: 8 weeks ]

3. 10. ALT and AST normalization: (alanine aminotransferase) in normal range at the end of treatment and post treatment.
[ Time Frame: 52 weeks ]

4. 2. Occurrence of adverse events (overall, and classified into mild/moderate/severe)
[ Time Frame: 52 weeks ]

5. 3. Occurrence of adverse events leading to treatment discontinuation
[ Time Frame: 52 weeks ]

6. 4. Occurrence of Serious Adverse Events (SAEs)
[ Time Frame: 52 weeks ]

7. 5. Occurrence of drug-related adverse events as assessed by the investigator
[ Time Frame: 52 weeks ]

8. 6. Occurrence of laboratory test abnormalities
[ Time Frame: 52 weeks ]

9. 7. Central tendency and changes from baseline in laboratory test values over time
[ Time Frame: 52 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion criteria:

  1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV 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.
  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:

  1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
  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.
Open or close this module Contacts/Locations
Study Officials: Boehringer Ingelheim
Study Chair
Boehringer Ingelheim
Locations: United States, Alabama
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
United States, Arizona
1220.47.0061 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, Arkansas
1220.47.0091 Boehringer Ingelheim Investigational Site
North Little Rock, Arkansas, United States
United States, California
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
United States, Colorado
1220.47.0082 Boehringer Ingelheim Investigational Site
Englewood, Colorado, United States
United States, Connecticut
1220.47.0049 Boehringer Ingelheim Investigational Site
New Haven, Connecticut, United States
United States, Florida
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
United States, Georgia
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
United States, Illinois
1220.47.0013 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1220.47.0055 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Indiana
1220.47.0062 Boehringer Ingelheim Investigational Site
Vaiparaiso, Indiana, United States
United States, Louisiana
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
United States, Maryland
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
United States, Massachusetts
1220.47.0027 Boehringer Ingelheim Investigational Site
Framingham, Massachusetts, United States
1220.47.0065 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
United States, Mississippi
1220.47.0023 Boehringer Ingelheim Investigational Site
Tulepo, Mississippi, United States
United States, Nevada
1220.47.0046 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
United States, New Jersey
1220.47.0066 Boehringer Ingelheim Investigational Site
Neptune, New Jersey, United States
United States, New York
1220.47.0097 Boehringer Ingelheim Investigational Site
Bronx, New York, 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
United States, North Carolina
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
United States, Oklahoma
1220.47.0098 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
United States, Oregon
1220.47.0028 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
1220.47.0058 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Tennessee
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
United States, Texas
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
United States, Vermont
1220.47.0015 Boehringer Ingelheim Investigational Site
Burlington, Vermont, United States
United States, Virginia
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
United States, Washington
1220.47.0092 Boehringer Ingelheim Investigational Site
Seattle, Washington, United States
United States, Wisconsin
1220.47.0073 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin, United States
Canada, Alberta
1220.47.1011 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1220.47.1012 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, British Columbia
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
Canada, Manitoba
1220.47.1009 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
Canada, Ontario
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
Canada, Quebec
1220.47.1010 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1220.47.1014 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Korea, Republic of
1220.47.8204 Boehringer Ingelheim Investigational Site
Pusan, Korea, Republic of
1220.47.8205 Boehringer Ingelheim Investigational Site
Pusan, Korea, Republic of
1220.47.8203 Boehringer Ingelheim Investigational Site
Seongnam, Korea, Republic of
1220.47.8202 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1220.47.8206 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1220.47.8207 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1220.47.8201 Boehringer Ingelheim Investigational Site
Yangsan, Korea, Republic of
Puerto Rico
1220.47.0034 Boehringer Ingelheim Investigational Site
Rio Piedras, Puerto Rico
Taiwan
1220.47.8803 Boehringer Ingelheim Investigational Site
Kaohsiung, Taiwan
1220.47.8804 Boehringer Ingelheim Investigational Site
Kaohsiung, 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
Open or close this module IPDSharing
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