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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)

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

BI201335

PegIFN/RBV

BI201335

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 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:
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.
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.
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:
1. International normalized ratio (INR) of =1.7
2. Serum Albumin =3.5 g/dL
3. 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

PegIFN/RBV

BI 201335 for 24 weeks

BI201335 for 12 weeks

Placebo

Arm Description

48 weeks

BI 201 335 QD dosing in combination with IFN/RBV

BI 201335 QD doing in combination with PEFG IFN/RBV

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sustained Virologic Response 24 Weeks Post-treatment (SVR24)

Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration. Hepatitis C virus Ribonucleic acid (HCV RNA)

Early Treatment Success (ETS)

Percentage of participants with 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.

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

The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

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

The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

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

The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO

The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

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

The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

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

The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

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

The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO

The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

Full Information

NCT ID

NCT01297270

First Posted

February 15, 2011

Last Updated

August 18, 2015

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01297270

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 2)

Official Title

A Phase III, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive 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

April 2014 (Actual)

Study Completion Date

April 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

658 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PegIFN/RBV

Arm Type

Active Comparator

Arm Description

48 weeks

Arm Title

BI 201335 for 24 weeks

Arm Type

Experimental

Arm Description

BI 201 335 QD dosing in combination with IFN/RBV

Arm Title

BI201335 for 12 weeks

Arm Type

Experimental

Arm Description

BI 201335 QD doing in combination with PEFG IFN/RBV

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

BI201335

Intervention Description

QD BI 201335

Intervention Type

Drug

Intervention Name(s)

PegIFN/RBV

Intervention Type

Drug

Intervention Name(s)

BI201335

Intervention Description

QD (once daily) BI 201335

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Sustained Virologic Response 12 Weeks Post Treatment (SVR12)

Description

Time Frame

12 weeks post treatment, up to 60 weeks

Secondary Outcome Measure Information:

Title

Sustained Virologic Response 24 Weeks Post-treatment (SVR24)

Description

Time Frame

24 weeks post treatment, up to 72 weeks

Title

Early Treatment Success (ETS)

Description

Percentage of participants with 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

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

Description

The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

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

Description

Time Frame

12 weeks post treatment, up to 60 weeks

Title

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

Description

The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO

Description

The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

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

Description

The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

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

Description

Time Frame

12 weeks post treatment, up to 60 weeks

Title

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

Description

The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Time Frame

12 weeks post treatment, up to 60 weeks

Title

AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO

Description

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 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 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. 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.

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

1220.47.0004 Boehringer Ingelheim Investigational Site

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

1220.47.0045 Boehringer Ingelheim Investigational Site

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

1220.47.0050 Boehringer Ingelheim Investigational Site

City

Dothan

State/Province

Alabama

Country

United States

Facility Name

1220.47.0061 Boehringer Ingelheim Investigational Site

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

1220.47.0091 Boehringer Ingelheim Investigational Site

City

North Little Rock

State/Province

Arkansas

Country

United States

Facility Name

1220.47.0008 Boehringer Ingelheim Investigational Site

City

Bakersfield

State/Province

California

Country

United States

Facility Name

1220.47.0019 Boehringer Ingelheim Investigational Site

City

Chula Vista

State/Province

California

Country

United States

Facility Name

1220.47.0010 Boehringer Ingelheim Investigational Site

City

Coronado

State/Province

California

Country

United States

Facility Name

1220.47.0033 Boehringer Ingelheim Investigational Site

City

La Jolla

State/Province

California

Country

United States

Facility Name

1220.47.0035 Boehringer Ingelheim Investigational Site

City

La Mesa

State/Province

California

Country

United States

Facility Name

1220.47.0011 Boehringer Ingelheim Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

1220.47.0014 Boehringer Ingelheim Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

1220.47.0100 Boehringer Ingelheim Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

1220.47.0018 Boehringer Ingelheim Investigational Site

City

Oceanside

State/Province

California

Country

United States

Facility Name

1220.47.0059 Boehringer Ingelheim Investigational Site

City

Poway

State/Province

California

Country

United States

Facility Name

1220.47.0024 Boehringer Ingelheim Investigational Site

City

San Diego

State/Province

California

Country

United States

Facility Name

1220.47.0037 Boehringer Ingelheim Investigational Site

City

San Diego

State/Province

California

Country

United States

Facility Name

1220.47.0031 Boehringer Ingelheim Investigational Site

City

San Francisco

State/Province

California

Country

United States

Facility Name

1220.47.0082 Boehringer Ingelheim Investigational Site

City

Englewood

State/Province

Colorado

Country

United States

Facility Name

1220.47.0049 Boehringer Ingelheim Investigational Site

City

New Haven

State/Province

Connecticut

Country

United States

Facility Name

1220.47.0057 Boehringer Ingelheim Investigational Site

City

Bradenton

State/Province

Florida

Country

United States

Facility Name

1220.47.0078 Boehringer Ingelheim Investigational Site

City

Fort Lauderdale

State/Province

Florida

Country

United States

Facility Name

1220.47.0086 Boehringer Ingelheim Investigational Site

City

Fort Lauderdale

State/Province

Florida

Country

United States

Facility Name

1220.47.0054 Boehringer Ingelheim Investigational Site

City

Hialeah

State/Province

Florida

Country

United States

Facility Name

1220.47.0088 Boehringer Ingelheim Investigational Site

City

Miami

State/Province

Florida

Country

United States

Facility Name

1220.47.0044 Boehringer Ingelheim Investigational Site

City

Orlando

State/Province

Florida

Country

United States

Facility Name

1220.47.0099 Boehringer Ingelheim Investigational Site

City

Orlando

State/Province

Florida

Country

United States

Facility Name

1220.47.0095 Boehringer Ingelheim Investigational Site

City

Palm Harbor

State/Province

Florida

Country

United States

Facility Name

1220.47.0074 Boehringer Ingelheim Investigational Site

City

Tampa

State/Province

Florida

Country

United States

Facility Name

1220.47.0022 Boehringer Ingelheim Investigational Site

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

1220.47.0039 Boehringer Ingelheim Investigational Site

City

Columbus

State/Province

Georgia

Country

United States

Facility Name

1220.47.0052 Boehringer Ingelheim Investigational Site

City

Decatur

State/Province

Georgia

Country

United States

Facility Name

1220.47.0013 Boehringer Ingelheim Investigational Site

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

1220.47.0055 Boehringer Ingelheim Investigational Site

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

1220.47.0062 Boehringer Ingelheim Investigational Site

City

Vaiparaiso

State/Province

Indiana

Country

United States

Facility Name

1220.47.0085 Boehringer Ingelheim Investigational Site

City

Baton Rouge

State/Province

Louisiana

Country

United States

Facility Name

1220.47.0087 Boehringer Ingelheim Investigational Site

City

Baton Rouge

State/Province

Louisiana

Country

United States

Facility Name

1220.47.0101 Boehringer Ingelheim Investigational Site

City

New Orleans

State/Province

Louisiana

Country

United States

Facility Name

1220.47.0064 Boehringer Ingelheim Investigational Site

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

1220.47.0069 Boehringer Ingelheim Investigational Site

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

1220.47.0067 Boehringer Ingelheim Investigational Site

City

Chevy Chase

State/Province

Maryland

Country

United States

Facility Name

1220.47.0079 Boehringer Ingelheim Investigational Site

City

Lutherville

State/Province

Maryland

Country

United States

Facility Name

1220.47.0027 Boehringer Ingelheim Investigational Site

City

Framingham

State/Province

Massachusetts

Country

United States

Facility Name

1220.47.0065 Boehringer Ingelheim Investigational Site

City

Springfield

State/Province

Massachusetts

Country

United States

Facility Name

1220.47.0023 Boehringer Ingelheim Investigational Site

City

Tulepo

State/Province

Mississippi

Country

United States

Facility Name

1220.47.0046 Boehringer Ingelheim Investigational Site

City

Las Vegas

State/Province

Nevada

Country

United States

Facility Name

1220.47.0066 Boehringer Ingelheim Investigational Site

City

Neptune

State/Province

New Jersey

Country

United States

Facility Name

1220.47.0097 Boehringer Ingelheim Investigational Site

City

Bronx

State/Province

New York

Country

United States

Facility Name

1220.47.0083 Boehringer Ingelheim Investigational Site

City

Brooklyn

State/Province

New York

Country

United States

Facility Name

1220.47.0003 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1220.47.0006 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1220.47.0038 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1220.47.0090 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1220.47.0053 Boehringer Ingelheim Investigational Site

City

Charlotte

State/Province

North Carolina

Country

United States

Facility Name

1220.47.0021 Boehringer Ingelheim Investigational Site

City

Winston-Salem

State/Province

North Carolina

Country

United States

Facility Name

1220.47.0098 Boehringer Ingelheim Investigational Site

City

Tulsa

State/Province

Oklahoma

Country

United States

Facility Name

1220.47.0028 Boehringer Ingelheim Investigational Site

City

Portland

State/Province

Oregon

Country

United States

Facility Name

1220.47.0058 Boehringer Ingelheim Investigational Site

City

Portland

State/Province

Oregon

Country

United States

Facility Name

1220.47.0030 Boehringer Ingelheim Investigational Site

City

Germantown

State/Province

Tennessee

Country

United States

Facility Name

1220.47.0072 Boehringer Ingelheim Investigational Site

City

Jackson

State/Province

Tennessee

Country

United States

Facility Name

1220.47.0032 Boehringer Ingelheim Investigational Site

City

Nashville

State/Province

Tennessee

Country

United States

Facility Name

1220.47.0041 Boehringer Ingelheim Investigational Site

City

Nashville

State/Province

Tennessee

Country

United States

Facility Name

1220.47.0063 Boehringer Ingelheim Investigational Site

City

Arlington

State/Province

Texas

Country

United States

Facility Name

1220.47.0029 Boehringer Ingelheim Investigational Site

City

Austin

State/Province

Texas

Country

United States

Facility Name

1220.47.0017 Boehringer Ingelheim Investigational Site

City

Dallas

State/Province

Texas

Country

United States

Facility Name

1220.47.0056 Boehringer Ingelheim Investigational Site

City

Dallas

State/Province

Texas

Country

United States

Facility Name

1220.47.0071 Boehringer Ingelheim Investigational Site

City

Dallas

State/Province

Texas

Country

United States

Facility Name

1220.47.0060 Boehringer Ingelheim Investigational Site

City

Fort Worth

State/Province

Texas

Country

United States

Facility Name

1220.47.0081 Boehringer Ingelheim Investigational Site

City

Forth Worth

State/Province

Texas

Country

United States

Facility Name

1220.47.0009 Boehringer Ingelheim Investigational Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

1220.47.0068 Boehringer Ingelheim Investigational Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

1220.47.0016 Boehringer Ingelheim Investigational Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

1220.47.0015 Boehringer Ingelheim Investigational Site

City

Burlington

State/Province

Vermont

Country

United States

Facility Name

1220.47.0042 Boehringer Ingelheim Investigational Site

City

Annandale

State/Province

Virginia

Country

United States

Facility Name

1220.47.0043 Boehringer Ingelheim Investigational Site

City

Falls Church

State/Province

Virginia

Country

United States

Facility Name

1220.47.0026 Boehringer Ingelheim Investigational Site

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

1220.47.0092 Boehringer Ingelheim Investigational Site

City

Seattle

State/Province

Washington

Country

United States

Facility Name

1220.47.0073 Boehringer Ingelheim Investigational Site

City

Milwaukee

State/Province

Wisconsin

Country

United States

Facility Name

1220.47.1011 Boehringer Ingelheim Investigational Site

City

Calgary

State/Province

Alberta

Country

Canada

Facility Name

1220.47.1012 Boehringer Ingelheim Investigational Site

City

Edmonton

State/Province

Alberta

Country

Canada

Facility Name

1220.47.1001 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

1220.47.1003 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

1220.47.1016 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

1220.47.1007 Boehringer Ingelheim Investigational Site

City

Victoria

State/Province

British Columbia

Country

Canada

Facility Name

1220.47.1009 Boehringer Ingelheim Investigational Site

City

Winnipeg

State/Province

Manitoba

Country

Canada

Facility Name

1220.47.1013 Boehringer Ingelheim Investigational Site

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

1220.47.1002 Boehringer Ingelheim Investigational Site

City

London

State/Province

Ontario

Country

Canada

Facility Name

1220.47.1004 Boehringer Ingelheim Investigational Site

City

Ottawa

State/Province

Ontario

Country

Canada

Facility Name

1220.47.1005 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1220.47.1006 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1220.47.1015 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1220.47.1010 Boehringer Ingelheim Investigational Site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

1220.47.1014 Boehringer Ingelheim Investigational Site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

1220.47.8204 Boehringer Ingelheim Investigational Site

City

Pusan

Country

Korea, Republic of

Facility Name

1220.47.8205 Boehringer Ingelheim Investigational Site

City

Pusan

Country

Korea, Republic of

Facility Name

1220.47.8203 Boehringer Ingelheim Investigational Site

City

Seongnam

Country

Korea, Republic of

Facility Name

1220.47.8202 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1220.47.8206 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1220.47.8207 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1220.47.8201 Boehringer Ingelheim Investigational Site

City

Yangsan

Country

Korea, Republic of

Facility Name

1220.47.0034 Boehringer Ingelheim Investigational Site

City

San Juan

Country

Puerto Rico

Facility Name

1220.47.8803 Boehringer Ingelheim Investigational Site

City

Kaohsiung

Country

Taiwan

Facility Name

1220.47.8804 Boehringer Ingelheim Investigational Site

City

Kaohsiung

Country

Taiwan

Facility Name

1220.47.8802 Boehringer Ingelheim Investigational Site

City

Taichung

Country

Taiwan

Facility Name

1220.47.8801 Boehringer Ingelheim Investigational Site

City

Taipei

Country

Taiwan

Facility Name

1220.47.8805 Boehringer Ingelheim Investigational Site

City

Taipei

Country

Taiwan

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

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 2)

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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)

Hepatitis C

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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