Back to results

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)

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

PegIFN/RBV

BI 201335

Placebo

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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.
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 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.
Age 18 to 70 years
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).
Signed informed consent form prior to trial participation

Exclusion criteria:

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. Incidental steatosis diagnosed by biopsy is not an exclusion criterion.
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 patients ability to participate in this study
Usage of any investigational drugs within 30 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 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.
Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to randomization and throughout the treatment phase of this trial.
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).

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

PegIFN/RBV

BI 201335 for 12 or 24 weeks

Placebo and PegIFN/RBV

Arm Description

PegIFN/RBV for 48 weeks

BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks

Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.

Outcomes

Primary Outcome Measures

Sustained Virological Response 12 Weeks Post-treatment (SVR12)

Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level < 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

Secondary Outcome Measures

Sustained Virological Response 24 Weeks Post-treatment (SVR24)

Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.

Early Treatment Success (ETS)

Early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES

This will be presented as the number of patients. BL = Baseline

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO

This will be presented as the number of patients. BL = Baseline

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES

This will be presented as the number of patients. BL = Baseline

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO

This will be presented as the number of patients. BL = Baseline

Full Information

NCT ID

NCT01343888

First Posted

April 20, 2011

Last Updated

August 18, 2015

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01343888

Brief 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)

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

656 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PegIFN/RBV

Arm Type

Active Comparator

Arm Description

PegIFN/RBV for 48 weeks

Arm Title

BI 201335 for 12 or 24 weeks

Arm Type

Experimental

Arm Description

BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks

Arm Title

Placebo and PegIFN/RBV

Arm Type

Active Comparator

Arm Description

Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.

Intervention Type

Drug

Intervention Name(s)

PegIFN/RBV

Intervention Description

PegIFN/RBV for 48 weeks

Intervention Type

Drug

Intervention Name(s)

BI 201335

Intervention Description

BI 201335 once daily high dose

Intervention Type

Drug

Intervention Name(s)

BI 201335

Intervention Description

BI 201335 once daily low dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Sustained Virological Response 12 Weeks Post-treatment (SVR12)

Description

Time Frame

12 weeks post treatment, up to 60 weeks

Secondary Outcome Measure Information:

Title

Sustained Virological Response 24 Weeks Post-treatment (SVR24)

Description

Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.

Time Frame

24 weeks post treatment, up to 72 weeks

Title

Early Treatment Success (ETS)

Description

Early treatment success (ETS), defined as a 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

week 4 and week 8

Title

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES

Description

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO

Description

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES

Description

This will be presented as the number of patients. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO

Description

This will be presented as the number of patients. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES

Description

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO

Description

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES

Description

This will be presented as the number of patients. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO

Description

This will be presented as the number of patients. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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 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. Age 18 to 70 years Female patients: with documented hysterectomy, who have had both ovaries removed, with documented tubal ligation, who are post-menopausal with last menstrual period at least 12 months prior to screening, or 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. 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). Signed informed consent form prior to trial participation Exclusion criteria: 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. Incidental steatosis diagnosed by biopsy is not an exclusion criterion. 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 patients ability to participate in this study Usage of any investigational drugs within 30 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 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. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to randomization and throughout the treatment phase of this trial. 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). Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1220.30.4303 Boehringer Ingelheim Investigational Site

City

Linz

Country

Austria

Facility Name

1220.30.4301 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

1220.30.4302 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

1220.30.4304 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

1220.30.3201 Boehringer Ingelheim Investigational Site

City

Bruxelles

Country

Belgium

Facility Name

1220.30.3207 Boehringer Ingelheim Investigational Site

City

Bruxelles

Country

Belgium

Facility Name

1220.30.3204 Boehringer Ingelheim Investigational Site

City

Edegem

Country

Belgium

Facility Name

1220.30.3205 Boehringer Ingelheim Investigational Site

City

Gent

Country

Belgium

Facility Name

1220.30.3202 Boehringer Ingelheim Investigational Site

City

Leuven

Country

Belgium

Facility Name

1220.30.3203 Boehringer Ingelheim Investigational Site

City

Liège

Country

Belgium

Facility Name

1220.30.3314 Boehringer Ingelheim Investigational Site

City

Clermont-Ferrand

Country

France

Facility Name

1220.30.3301 Boehringer Ingelheim Investigational Site

City

Clichy

Country

France

Facility Name

1220.30.3311 Boehringer Ingelheim Investigational Site

City

Lille

Country

France

Facility Name

1220.30.3303 Boehringer Ingelheim Investigational Site

City

Marseille

Country

France

Facility Name

1220.30.3304 Boehringer Ingelheim Investigational Site

City

Montpellier

Country

France

Facility Name

1220.30.3305 Boehringer Ingelheim Investigational Site

City

Nice Cedex 3

Country

France

Facility Name

1220.30.3309 Boehringer Ingelheim Investigational Site

City

Paris Cedex 20

Country

France

Facility Name

1220.30.3302 Boehringer Ingelheim Investigational Site

City

Paris

Country

France

Facility Name

1220.30.3316 Boehringer Ingelheim Investigational Site

City

Pessac Cedex

Country

France

Facility Name

1220.30.3315 Boehringer Ingelheim Investigational Site

City

Rennes Cedex 09

Country

France

Facility Name

1220.30.3312 Boehringer Ingelheim Investigational Site

City

Saint Laurent du Var

Country

France

Facility Name

1220.30.3313 Boehringer Ingelheim Investigational Site

City

Toulouse

Country

France

Facility Name

1220.30.4917 Boehringer Ingelheim Investigational Site

City

Aachen

Country

Germany

Facility Name

1220.30.4902 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1220.30.4904 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1220.30.4916 Boehringer Ingelheim Investigational Site

City

Bonn

Country

Germany

Facility Name

1220.30.4913 Boehringer Ingelheim Investigational Site

City

Dortmund

Country

Germany

Facility Name

1220.30.4906 Boehringer Ingelheim Investigational Site

City

Düsseldorf

Country

Germany

Facility Name

1220.30.4909 Boehringer Ingelheim Investigational Site

City

Düsseldorf

Country

Germany

Facility Name

1220.30.4912 Boehringer Ingelheim Investigational Site

City

Erlangen

Country

Germany

Facility Name

1220.30.4901 Boehringer Ingelheim Investigational Site

City

Frankfurt am Main

Country

Germany

Facility Name

1220.30.4908 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

1220.30.4907 Boehringer Ingelheim Investigational Site

City

Herne

Country

Germany

Facility Name

1220.30.4914 Boehringer Ingelheim Investigational Site

City

Kiel

Country

Germany

Facility Name

1220.30.4903 Boehringer Ingelheim Investigational Site

City

Leipzig

Country

Germany

Facility Name

1220.30.4911 Boehringer Ingelheim Investigational Site

City

Mainz

Country

Germany

Facility Name

1220.30.4905 Boehringer Ingelheim Investigational Site

City

München

Country

Germany

Facility Name

1220.30.4915 Boehringer Ingelheim Investigational Site

City

Ulm

Country

Germany

Facility Name

1220.30.8106 Boehringer Ingelheim Investigational Site

City

Chiba, Chiba

Country

Japan

Facility Name

1220.30.8111 Boehringer Ingelheim Investigational Site

City

Gifu, Gifu

Country

Japan

Facility Name

1220.30.8107 Boehringer Ingelheim Investigational Site

City

Itabashi-ku, Tokyo

Country

Japan

Facility Name

1220.30.8112 Boehringer Ingelheim Investigational Site

City

Izunokuni, Shizuoka

Country

Japan

Facility Name

1220.30.8108 Boehringer Ingelheim Investigational Site

City

Kamakura, Kanagawa

Country

Japan

Facility Name

1220.30.8117 Boehringer Ingelheim Investigational Site

City

Kita-gun, Kagawa

Country

Japan

Facility Name

1220.30.8109 Boehringer Ingelheim Investigational Site

City

Kofu, Yamanashi

Country

Japan

Facility Name

1220.30.8116 Boehringer Ingelheim Investigational Site

City

Kurashiki, Okayama

Country

Japan

Facility Name

1220.30.8118 Boehringer Ingelheim Investigational Site

City

Kurume, Fukuoka

Country

Japan

Facility Name

1220.30.8110 Boehringer Ingelheim Investigational Site

City

Matsumoto, Nagano

Country

Japan

Facility Name

1220.30.8113 Boehringer Ingelheim Investigational Site

City

Nagoya, Aichi

Country

Japan

Facility Name

1220.30.8105 Boehringer Ingelheim Investigational Site

City

Namegata, Ibaraki

Country

Japan

Facility Name

1220.30.8114 Boehringer Ingelheim Investigational Site

City

Nishinomiya, Hyogo

Country

Japan

Facility Name

1220.30.8119 Boehringer Ingelheim Investigational Site

City

Omura, Nagasaki

Country

Japan

Facility Name

1220.30.8122 Boehringer Ingelheim Investigational Site

City

Omuta, Fukuoka

Country

Japan

Facility Name

1220.30.8121 Boehringer Ingelheim Investigational Site

City

Osaka, Osaka

Country

Japan

Facility Name

1220.30.8101 Boehringer Ingelheim Investigational Site

City

Sapporo, Hokkaido

Country

Japan

Facility Name

1220.30.8102 Boehringer Ingelheim Investigational Site

City

Sendai, Miyagi

Country

Japan

Facility Name

1220.30.8115 Boehringer Ingelheim Investigational Site

City

Tanabe, Wakayama

Country

Japan

Facility Name

1220.30.8104 Boehringer Ingelheim Investigational Site

City

Tsuchiura, Ibaraki

Country

Japan

Facility Name

1220.30.3503 Boehringer Ingelheim Investigational Site

City

Aveiro

Country

Portugal

Facility Name

1220.30.3509 Boehringer Ingelheim Investigational Site

City

Barreiro

Country

Portugal

Facility Name

1220.30.3506 Boehringer Ingelheim Investigational Site

City

Coimbra

Country

Portugal

Facility Name

1220.30.3501 Boehringer Ingelheim Investigational Site

City

Lisboa

Country

Portugal

Facility Name

1220.30.3505 Boehringer Ingelheim Investigational Site

City

Lisboa

Country

Portugal

Facility Name

1220.30.3507 Boehringer Ingelheim Investigational Site

City

Lisboa

Country

Portugal

Facility Name

1220.30.3502 Boehringer Ingelheim Investigational Site

City

Porto

Country

Portugal

Facility Name

1220.30.3504 Boehringer Ingelheim Investigational Site

City

Vila Real

Country

Portugal

Facility Name

1220.30.4001 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1220.30.4002 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1220.30.4003 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1220.30.4004 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1220.30.7002 Boehringer Ingelheim Investigational Site

City

Chelyabinsk

Country

Russian Federation

Facility Name

1220.30.7001 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1220.30.7004 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1220.30.7005 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1220.30.7006 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

1220.30.7007 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

1220.30.3406 Boehringer Ingelheim Investigational Site

City

A Coruña

Country

Spain

Facility Name

1220.30.3402 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1220.30.3404 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1220.30.3405 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1220.30.3408 Boehringer Ingelheim Investigational Site

City

Santander

Country

Spain

Facility Name

1220.30.3403 Boehringer Ingelheim Investigational Site

City

Sevilla

Country

Spain

Facility Name

1220.30.3401 Boehringer Ingelheim Investigational Site

City

Valencia

Country

Spain

Facility Name

1220.30.3407 Boehringer Ingelheim Investigational Site

City

Vigo (Pontevedra)

Country

Spain

Facility Name

1220.30.4106 Boehringer Ingelheim Investigational Site

City

Bern

Country

Switzerland

Facility Name

1220.30.4103 Boehringer Ingelheim Investigational Site

City

La Chaux-de-Fonds

Country

Switzerland

Facility Name

1220.30.4107 Boehringer Ingelheim Investigational Site

City

Lugano

Country

Switzerland

Facility Name

1220.30.4108 Boehringer Ingelheim Investigational Site

City

St. Gallen

Country

Switzerland

Facility Name

1220.30.4101 Boehringer Ingelheim Investigational Site

City

Zürich

Country

Switzerland

Facility Name

1220.30.4405 Boehringer Ingelheim Investigational Site

City

Bristol

Country

United Kingdom

Facility Name

1220.30.4404 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1220.30.4409 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1220.30.4410 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1220.30.4401 Boehringer Ingelheim Investigational Site

City

Manchester

Country

United Kingdom

Facility Name

1220.30.4408 Boehringer Ingelheim Investigational Site

City

Nottingham

Country

United Kingdom

Facility Name

1220.30.4407 Boehringer Ingelheim Investigational Site

City

Oxford

Country

United Kingdom

Facility Name

1220.30.4403 Boehringer Ingelheim Investigational Site

City

Southampton

Country

United Kingdom

Facility Name

1220.30.4406 Boehringer Ingelheim Investigational Site

City

Whitechapel, London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27049487

Citation

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.

Results Reference

derived

PubMed Identifier

25710287

Citation

Dieterich D, Nelson M, Soriano V, Arasteh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon alpha-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.

Results Reference

derived

PubMed Identifier

25559324

Citation

Ferenci P, Asselah T, Foster GR, Zeuzem S, Sarrazin C, Moreno C, Ouzan D, Maevskaya M, Calinas F, Morano LE, Crespo J, Dufour JF, Bourliere M, Agarwal K, Forton D, Schuchmann M, Zehnter E, Nishiguchi S, Omata M, Kukolj G, Datsenko Y, Garcia M, Scherer J, Quinson AM, Stern JO; STARTVerso1 Study Group. STARTVerso1: A randomized trial of faldaprevir plus pegylated interferon/ribavirin for chronic HCV genotype-1 infection. J Hepatol. 2015 Jun;62(6):1246-55. doi: 10.1016/j.jhep.2014.12.024. Epub 2015 Jan 2.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com/

Description

Related Info

Learn more about this trial

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)

We'll reach out to this number within 24 hrs

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)

Hepatitis C

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial