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)

NCT01297270 | Completed Phase 3 Results

• 2 other identifiers: 1220.472010-021716-42
• Study Type: interventional
• Target: 658
• Locations: 5 countries
• Sites: 106

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response 12 Weeks Post Treatment (SVR12)

  Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level\<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

  12 weeks post treatment, up to 60 weeks

Secondary Outcomes (10)

• Sustained Virologic Response 24 Weeks Post-treatment (SVR24)

  24 weeks post treatment, up to 72 weeks

• Early Treatment Success (ETS)

  Week 4 and week 8

• ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES

  12 weeks post treatment, up to 60 weeks

• ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO

  12 weeks post treatment, up to 60 weeks

• ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES

  12 weeks post treatment, up to 60 weeks

Study Arms (4)

PegIFN/RBV

ACTIVE COMPARATOR

48 weeks

Drug: PegIFN/RBV

BI 201335 for 24 weeks

EXPERIMENTAL

BI 201 335 QD dosing in combination with IFN/RBV

Drug: PegIFN/RBV; Drug: BI201335

BI201335 for 12 weeks

EXPERIMENTAL

BI 201335 QD doing in combination with PEFG IFN/RBV

Drug: BI201335; Drug: PegIFN/RBV

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI201335 DRUG

QD BI 201335

BI201335 for 12 weeks

PegIFN/RBV DRUG

BI 201335 for 24 weeks; BI201335 for 12 weeks; PegIFN/RBV

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:
• positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
• liver biopsy consistent with chronic HCV infection.
• HCV genotype 1 infection confirmed by genotypic testing at screening.
• Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
• HCV RNA = 1,000 IU/mL at screening
• 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.
• Age 18 to 70 years
• 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:
• who are documented to be sterile, or
• 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.

You may not qualify if:

• HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
• Evidence of acute or chronic liver disease due to causes other than chronic HCV infection.
• HIV co-infection.
• Hepatitis B virus (HBV) infection based on presence of HBs-Ag.
• 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)
• Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
• 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.
• Usage of any investigational drugs within 28 days prior to screening, or planned usage of an investigational drug during the course of this study.
• 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.
• Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to screening and throughout the treatment phase.
• Known hypersensitivity to any ingredient of the study drugs.
• 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).
• 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:
• International normalized ratio (INR) of =1.7
• Serum Albumin =3.5 g/dL

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (106)

1220.47.0004 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

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1220.47.0045 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

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1220.47.0050 Boehringer Ingelheim Investigational Site

Dothan, Alabama, United States

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1220.47.0061 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

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1220.47.0091 Boehringer Ingelheim Investigational Site

North Little Rock, Arkansas, United States

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1220.47.0008 Boehringer Ingelheim Investigational Site

Bakersfield, California, United States

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1220.47.0019 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

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1220.47.0010 Boehringer Ingelheim Investigational Site

Coronado, California, United States

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1220.47.0033 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Location

1220.47.0035 Boehringer Ingelheim Investigational Site

La Mesa, California, United States

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1220.47.0011 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

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1220.47.0014 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1220.47.0100 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

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1220.47.0018 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

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1220.47.0059 Boehringer Ingelheim Investigational Site

Poway, California, United States

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1220.47.0024 Boehringer Ingelheim Investigational Site

San Diego, California, United States

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1220.47.0037 Boehringer Ingelheim Investigational Site

San Diego, California, United States

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1220.47.0031 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

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1220.47.0082 Boehringer Ingelheim Investigational Site

Englewood, Colorado, United States

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1220.47.0049 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

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1220.47.0057 Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

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1220.47.0078 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

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1220.47.0086 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

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1220.47.0054 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

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1220.47.0088 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

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1220.47.0044 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

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1220.47.0099 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

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1220.47.0095 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

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1220.47.0074 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

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1220.47.0022 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

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1220.47.0039 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

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1220.47.0052 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

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1220.47.0013 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

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1220.47.0055 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

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1220.47.0062 Boehringer Ingelheim Investigational Site

Vaiparaiso, Indiana, United States

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1220.47.0085 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

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1220.47.0087 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

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1220.47.0101 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

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1220.47.0064 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

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1220.47.0069 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

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1220.47.0067 Boehringer Ingelheim Investigational Site

Chevy Chase, Maryland, United States

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1220.47.0079 Boehringer Ingelheim Investigational Site

Lutherville, Maryland, United States

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1220.47.0027 Boehringer Ingelheim Investigational Site

Framingham, Massachusetts, United States

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1220.47.0065 Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

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1220.47.0023 Boehringer Ingelheim Investigational Site

Tulepo, Mississippi, United States

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1220.47.0046 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

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1220.47.0066 Boehringer Ingelheim Investigational Site

Neptune City, New Jersey, United States

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1220.47.0083 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

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1220.47.0003 Boehringer Ingelheim Investigational Site

New York, New York, United States

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1220.47.0006 Boehringer Ingelheim Investigational Site

New York, New York, United States

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1220.47.0038 Boehringer Ingelheim Investigational Site

New York, New York, United States

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1220.47.0090 Boehringer Ingelheim Investigational Site

New York, New York, United States

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1220.47.0097 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

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1220.47.0053 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

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1220.47.0021 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

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1220.47.0098 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

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1220.47.0028 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

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1220.47.0058 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

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1220.47.0030 Boehringer Ingelheim Investigational Site

Germantown, Tennessee, United States

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1220.47.0072 Boehringer Ingelheim Investigational Site

Jackson, Tennessee, United States

Location

1220.47.0032 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

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1220.47.0041 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

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1220.47.0063 Boehringer Ingelheim Investigational Site

Arlington, Texas, United States

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1220.47.0029 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

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1220.47.0017 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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1220.47.0056 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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1220.47.0071 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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1220.47.0060 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

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1220.47.0081 Boehringer Ingelheim Investigational Site

Forth Worth, Texas, United States

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1220.47.0009 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1220.47.0068 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1220.47.0016 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1220.47.0015 Boehringer Ingelheim Investigational Site

Burlington, Vermont, United States

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1220.47.0042 Boehringer Ingelheim Investigational Site

Annandale, Virginia, United States

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1220.47.0043 Boehringer Ingelheim Investigational Site

Falls Church, Virginia, United States

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1220.47.0026 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1220.47.0092 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

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1220.47.0073 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

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1220.47.1011 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

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1220.47.1012 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

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1220.47.1001 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1220.47.1003 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1220.47.1016 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1220.47.1007 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

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1220.47.1009 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

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1220.47.1013 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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1220.47.1002 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

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1220.47.1004 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

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1220.47.1005 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1220.47.1006 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1220.47.1015 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1220.47.1010 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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1220.47.1014 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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1220.47.0034 Boehringer Ingelheim Investigational Site

San Juan, Puerto Rico

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1220.47.8204 Boehringer Ingelheim Investigational Site

Pusan, South Korea

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1220.47.8205 Boehringer Ingelheim Investigational Site

Pusan, South Korea

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1220.47.8203 Boehringer Ingelheim Investigational Site

Seongnam, South Korea

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1220.47.8202 Boehringer Ingelheim Investigational Site

Seoul, South Korea

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1220.47.8206 Boehringer Ingelheim Investigational Site

Seoul, South Korea

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1220.47.8207 Boehringer Ingelheim Investigational Site

Seoul, South Korea

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1220.47.8201 Boehringer Ingelheim Investigational Site

Yangsan, South Korea

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1220.47.8803 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

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1220.47.8804 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

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1220.47.8802 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

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1220.47.8801 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

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1220.47.8805 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 27049487 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

faldaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 16, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 18, 2015
• Results First Posted: September 18, 2015

Record last verified: 2015-08

Locations

CA (15); KR (7); US (78); TW (5); PR (1)