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 1)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01343888
• Date of registration: 20/04/2011
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public 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 1)
• Scientific title: A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection
• Date of first enrolment: April 2011
• Target sample size: 656
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01343888
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, France, Germany, Japan, Portugal, Romania, Russian Federation, Spain, Switzerland, United Kingdom

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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 prior to
randomization.

Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies
obtained more than 3 years before randomization need not be repeated. Biopsies may be
waived for patients who would be placed at risk from the procedure. Inability to do a
liver biopsy in patients at risk for the procedure should not exclude such patients
from a trial.

6. Age 18 to 70 years

7. Female patients:

1. with documented hysterectomy,

2. who have had both ovaries removed,

3. with documented tubal ligation,

4. who are post-menopausal with last menstrual period at least 12 months prior to
screening, or

5. 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. Female partners of childbearing potential should perform
monthly pregnancy tests from the date of screening until 7 months after the last
dose of ribavirin (tests will be provided by the sponsor).

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. Incidental steatosis diagnosed by biopsy is not an exclusion criterion.

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 patients ability to participate in this study

8. Usage of any investigational drugs within 30 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 30 days prior to randomization. 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 randomization and throughout the treatment phase of this trial.

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).

Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are
not listed here.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis C

Intervention(s)

Drug: BI 201335

Drug: Placebo

Drug: PegIFN/RBV

Primary Outcome(s)

Sustained Virological Response 12 Weeks Post-treatment (SVR12) [Time Frame: 12 weeks post treatment, up to 60 weeks]

Secondary Outcome(s)

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES [Time Frame: 12 weeks post treatment, up to 60 weeks]

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO [Time Frame: 12 weeks post treatment, up to 60 weeks]

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO [Time Frame: 12 weeks post treatment, up to 60 weeks]

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO [Time Frame: 12 weeks post treatment, up to 60 weeks]

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES [Time Frame: 12 weeks post treatment, up to 60 weeks]

Early Treatment Success (ETS) [Time Frame: week 4 and week 8]

Sustained Virological Response 24 Weeks Post-treatment (SVR24) [Time Frame: 24 weeks post treatment, up to 72 weeks]

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES [Time Frame: 12 weeks post treatment, up to 60 weeks]

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO [Time Frame: 12 weeks post treatment, up to 60 weeks]

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES [Time Frame: 12 weeks post treatment, up to 60 weeks]

Secondary ID(s)

2010-021716-42

1220.30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/09/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01343888