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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01297270
First received: February 15, 2011
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: BI201335
Drug: PegIFN/RBV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 10. ALT and AST normalization: (alanine aminotransferase) in normal range at the end of treatment and post treatment. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 2. Occurrence of adverse events (overall, and classified into mild/moderate/severe) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 3. Occurrence of adverse events leading to treatment discontinuation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 4. Occurrence of Serious Adverse Events (SAEs) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 5. Occurrence of drug-related adverse events as assessed by the investigator [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 6. Occurrence of laboratory test abnormalities [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 7. Central tendency and changes from baseline in laboratory test values over time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 659
Study Start Date: April 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297270

  Hide Study Locations
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
1220.47.0100 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1220.47.0014 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1220.47.0011 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
1220.47.0086 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1220.47.0078 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
1220.47.0087 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
1220.47.0085 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
1220.47.8207 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1220.47.8206 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1220.47.8202 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
San Juan, 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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01297270     History of Changes
Other Study ID Numbers: 1220.47, 2010-021716-42
Study First Received: February 15, 2011
Last Updated: May 6, 2014
Health Authority: Canada: Health Canada
South Korea: Ministry of Food and Drug Safety (MFDS)
Taiwan : Food and Drug Administration
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014