Trial record 3 of 4 for:    STARTVerso

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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01343888
First received: April 20, 2011
Last updated: March 17, 2014
Last verified: March 2014

April 20, 2011
March 17, 2014
April 2011
March 2014   (final data collection date for primary outcome measure)
Sustained Virological Response 12 weeks post-treatment (SVR12): Plasma HCV RNA level < 25 IU/mL, undetected 12 weeks after the originally planned treatment duration. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Sustained Virological Response (SVR): Plasma HCV RNA level < 25 IU/mL, undetected 24 weeks after the originally planned treatment duration. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01343888 on ClinicalTrials.gov Archive Site
  • Virological response after 24 weeks of treatment discontinuation (SVR24): - Plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • Alanine Aminotransferase and Aspartate Aminotransferase normalisation: Alanine Aminotransferase and Aspartate Aminotransferase in normal range at end of treatment and post-treatment [ Time Frame: 48 & 72 weeks ] [ Designated as safety issue: No ]
  • Virological response after 12 weeks of treatment discontinuation (SVR12): - Plasma HCV RNA level < 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • Alanine Aminotransferase normalisation: Alanine Aminotransferase in normal range 24 weeks after end of the originally planned treatment duration [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hepatitis C
  • Drug: PegIFN/RBV
    PegIFN/RBV for 48 weeks
  • Drug: BI 201335
    BI 201335 once daily high dose
  • Drug: BI 201335
    BI 201335 once daily low dose
  • Active Comparator: PegIFN/RBV
    PegIFN/RBV for 48 weeks
    Intervention: Drug: PegIFN/RBV
  • Experimental: BI 201335 for 12 or 24 weeks
    BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
    Intervention: Drug: BI 201335
  • Experimental: BI 201335 for 12 weeks
    BI 201335 once daily high dose for 12 weeks in combination with PegIFN/RBV for 24 or 48 weeks
    Intervention: Drug: BI 201335
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
656
March 2014
March 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Japan,   Portugal,   Romania,   Russian Federation,   Spain,   Switzerland,   United Kingdom
 
NCT01343888
1220.30, 2010-021716-42
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP