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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID: NCT01297270
Run by: Boehringer Ingelheim
People needed: 658
Starts: 2011-04-01
Expected to finish: 2014-04-01
Last updated by the study team: 2015-09-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.
Signed informed consent form prior to trial participation

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
Serum total bilirubin =2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilberts syndrome).
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.

Where it is running

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
1220.47.0004 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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