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A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

BI 201335

PegIFN/RBV

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 of GT-1 in patients who failed prior treatment with PegIFN and RBV in the 1220.7, 1220.30 and 1220.47 trials of the BI 201335 Phase III program.

Patients from trials 1220.7, 1220.30 and 1220.47 of BI 201335 who have failed treatment with PegIFN/RBV in the placebo groups due to protocol-defined criteria of treatment failure (i.e. either non-response on treatment or relapse after end of treatment [EOT]).
Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures.
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 RBV 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 RBV.
Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, intra-uterine device and cervical cap.
or
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) 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. 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 must 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:

Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criteria.
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 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 enrolment 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 Type

Experimental

Arm Label

BI 201335 for 24 weeks

Arm Description

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

Outcomes

Primary Outcome Measures

Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL

The primary endpoint was SVR12, defined as a 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 After 24 Weeks of Treatment Discontinuation (SVR24)

Sustained virologic response 24 weeks, defined as a plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.

Early Treatment Success (ETS)

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)

This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment.

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment.

This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT)

This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment.

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment.

This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.

Occurrence of Adverse Events (Overall and by DAIDS Grade)

This outcome measure will be presented as the percentage of subjects with any adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator. The intensity of all AEs was evaluated according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) grading scale with AEs of mild, moderate, or severe intensity receiving Grades 1, 2, or 3, respectively. Adverse events judged potentially life threatening received a Grade 4 assessment.

Occurrence of Adverse Events Leading to Treatment Discontinuation

This outcome measure will be presented as the percentage of subjects with adverse events leading to discontinuation of Faldaprevir and all study medication. Percentages are calculated using total number of subjects per treatment cohort as the denominator.

Occurrence of Serious Adverse Events (SAEs)

This outcome measure will be presented as the percentage of subjects with any serious adverse event (SAE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.

Occurrence of Drug-related AEs as Assessed by the Investigator

This outcome measure will be presented as the percentage of subjects with any drug-related AEs as assessed by the investigator. Percentages are calculated using total number of subjects per treatment cohort as the denominator.

Laboratory Test Abnormalities by DAIDS Grades

This Outcome measure will be presented as summary of the percentage of patients with worst on-treatment Division of Acquired Immunodeficiency Syndrome (DAIDS) grade laboratory abnormalities for selected analytes (Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total) with particular relevance to patients with HCV.

Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin]

This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure Haemoglobin is presented.

Changes From Baseline in Laboratory Test Values Over Time [ALT]

Changes From Baseline in Laboratory Test Values Over Time [AST]

Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total]

Full Information

NCT ID

NCT01330316

First Posted

April 5, 2011

Last Updated

May 31, 2016

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01330316

Brief Title

A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

Official Title

A Phase III, Open-label Study of Once Daily BI 201335 240 mg for 24 Weeks in Combination With Pegylated interferon-a (PegIFN) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN / RBV Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 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 collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

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

None (Open Label)

Allocation

Non-Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BI 201335 for 24 weeks

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BI 201335

Intervention Description

BI 201335 for 24 weeks

Intervention Type

Drug

Intervention Name(s)

PegIFN/RBV

Intervention Description

PegIFN/RBV for 48 weeks

Primary Outcome Measure Information:

Title

Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL

Description

The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

Time Frame

12 weeks post treatment, up to 60 weeks

Secondary Outcome Measure Information:

Title

Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)

Description

Sustained virologic response 24 weeks, defined as a 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

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)

Description

This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment.

Time Frame

Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers

Title

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment.

Description

This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.

Time Frame

48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS

Title

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT)

Description

This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment.

Time Frame

Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.

Title

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment.

Description

This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.

Time Frame

Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers

Title

Occurrence of Adverse Events (Overall and by DAIDS Grade)

Description

Time Frame

from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days

Title

Occurrence of Adverse Events Leading to Treatment Discontinuation

Description

Time Frame

from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days

Title

Occurrence of Serious Adverse Events (SAEs)

Description

Time Frame

from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days

Title

Occurrence of Drug-related AEs as Assessed by the Investigator

Description

Time Frame

from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days

Title

Laboratory Test Abnormalities by DAIDS Grades

Description

Time Frame

baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study

Title

Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin]

Description

Time Frame

baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)

Title

Changes From Baseline in Laboratory Test Values Over Time [ALT]

Description

Time Frame

baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)

Title

Changes From Baseline in Laboratory Test Values Over Time [AST]

Description

Time Frame

baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)

Title

Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total]

Description

Time Frame

baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)

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 of GT-1 in patients who failed prior treatment with PegIFN and RBV in the 1220.7, 1220.30 and 1220.47 trials of the BI 201335 Phase III program. Patients from trials 1220.7, 1220.30 and 1220.47 of BI 201335 who have failed treatment with PegIFN/RBV in the placebo groups due to protocol-defined criteria of treatment failure (i.e. either non-response on treatment or relapse after end of treatment [EOT]). Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures. 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 RBV 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 RBV. Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, intra-uterine device and cervical cap. or 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) 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. 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 must 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: Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criteria. 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 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 enrolment 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

1220.48.0004 Boehringer Ingelheim Investigational Site

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

1220.48.0091 Boehringer Ingelheim Investigational Site

City

North Little Rock

State/Province

Arkansas

Country

United States

Facility Name

1220.48.0011 Boehringer Ingelheim Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

1220.48.0018 Boehringer Ingelheim Investigational Site

City

Oceanside

State/Province

California

Country

United States

Facility Name

1220.48.0078 Boehringer Ingelheim Investigational Site

City

Fort Lauderdale

State/Province

Florida

Country

United States

Facility Name

1220.48.0095 Boehringer Ingelheim Investigational Site

City

Palm Harbor

State/Province

Florida

Country

United States

Facility Name

1220.48.0039 Boehringer Ingelheim Investigational Site

City

Columbus

State/Province

Georgia

Country

United States

Facility Name

1220.48.0013 Boehringer Ingelheim Investigational Site

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

1220.48.0087 Boehringer Ingelheim Investigational Site

City

Baton Rouge

State/Province

Louisiana

Country

United States

Facility Name

1220.48.0027 Boehringer Ingelheim Investigational Site

City

Framingham

State/Province

Massachusetts

Country

United States

Facility Name

1220.48.0065 Boehringer Ingelheim Investigational Site

City

Springfield

State/Province

Massachusetts

Country

United States

Facility Name

1220.48.0023 Boehringer Ingelheim Investigational Site

City

Tupelo

State/Province

Mississippi

Country

United States

Facility Name

1220.48.0066 Boehringer Ingelheim Investigational Site

City

Neptune

State/Province

New Jersey

Country

United States

Facility Name

1220.48.0012 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1220.48.0058 Boehringer Ingelheim Investigational Site

City

Portland

State/Province

Oregon

Country

United States

Facility Name

1220.48.0063 Boehringer Ingelheim Investigational Site

City

Arlington

State/Province

Texas

Country

United States

Facility Name

1220.48.0029 Boehringer Ingelheim Investigational Site

City

Austin

State/Province

Texas

Country

United States

Facility Name

1220.48.0017 Boehringer Ingelheim Investigational Site

City

Dallas

State/Province

Texas

Country

United States

Facility Name

1220.48.0071 Boehringer Ingelheim Investigational Site

City

Dallas

State/Province

Texas

Country

United States

Facility Name

1220.48.0081 Boehringer Ingelheim Investigational Site

City

Forth Worth

State/Province

Texas

Country

United States

Facility Name

1220.48.4301 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

1220.48.4302 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

1220.48.3201 Boehringer Ingelheim Investigational Site

City

Bruxelles

Country

Belgium

Facility Name

1220.48.3204 Boehringer Ingelheim Investigational Site

City

Edegem

Country

Belgium

Facility Name

1220.48.3203 Boehringer Ingelheim Investigational Site

City

Liège

Country

Belgium

Facility Name

1220.48.1012 Boehringer Ingelheim Investigational Site

City

Edmonton

State/Province

Alberta

Country

Canada

Facility Name

1220.48.1003 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

1220.48.1016 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

1220.48.1007 Boehringer Ingelheim Investigational Site

City

Victoria

State/Province

British Columbia

Country

Canada

Facility Name

1220.48.1009 Boehringer Ingelheim Investigational Site

City

Winnipeg

State/Province

Manitoba

Country

Canada

Facility Name

1220.48.1005 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1220.48.1006 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1220.48.3301 Boehringer Ingelheim Investigational Site

City

Clichy Cedex

Country

France

Facility Name

1220.48.3311 Boehringer Ingelheim Investigational Site

City

Lille Cedex

Country

France

Facility Name

1220.48.3303 Boehringer Ingelheim Investigational Site

City

Marseille Cedex 08

Country

France

Facility Name

1220.48.3304 Boehringer Ingelheim Investigational Site

City

Montpellier Cedex 5

Country

France

Facility Name

1220.48.3305 Boehringer Ingelheim Investigational Site

City

Nice Cedex 3

Country

France

Facility Name

1220.48.3316 Boehringer Ingelheim Investigational Site

City

Pessac Cedex

Country

France

Facility Name

1220.48.3312 Boehringer Ingelheim Investigational Site

City

Saint Laurent du Var

Country

France

Facility Name

1220.48.4902 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1220.48.4904 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1220.48.4913 Boehringer Ingelheim Investigational Site

City

Dortmund

Country

Germany

Facility Name

1220.48.4906 Boehringer Ingelheim Investigational Site

City

Düsseldorf

Country

Germany

Facility Name

1220.48.4901 Boehringer Ingelheim Investigational Site

City

Frankfurt am Main

Country

Germany

Facility Name

1220.48.4908 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

1220.48.4914 Boehringer Ingelheim Investigational Site

City

Kiel

Country

Germany

Facility Name

1220.48.4911 Boehringer Ingelheim Investigational Site

City

Mainz

Country

Germany

Facility Name

1220.48.4905 Boehringer Ingelheim Investigational Site

City

München

Country

Germany

Facility Name

1220.48.8106 Boehringer Ingelheim Investigational Site

City

Chiba, Chiba

Country

Japan

Facility Name

1220.48.8117 Boehringer Ingelheim Investigational Site

City

Kita-gun, Kagawa

Country

Japan

Facility Name

1220.48.8116 Boehringer Ingelheim Investigational Site

City

Kurashiki, Okayama

Country

Japan

Facility Name

1220.48.8118 Boehringer Ingelheim Investigational Site

City

Kurume, Fukuoka

Country

Japan

Facility Name

1220.48.8113 Boehringer Ingelheim Investigational Site

City

Nagoya, Aichi

Country

Japan

Facility Name

1220.48.8114 Boehringer Ingelheim Investigational Site

City

Nishinomiya, Hyogo

Country

Japan

Facility Name

1220.48.8119 Boehringer Ingelheim Investigational Site

City

Omura, Nagasaki

Country

Japan

Facility Name

1220.48.8121 Boehringer Ingelheim Investigational Site

City

Osaka, Osaka

Country

Japan

Facility Name

1220.48.8204 Boehringer Ingelheim Investigational Site

City

Pusan

Country

Korea, Republic of

Facility Name

1220.48.8205 Boehringer Ingelheim Investigational Site

City

Pusan

Country

Korea, Republic of

Facility Name

1220.48.8206 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1220.48.8207 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1220.48.8201 Boehringer Ingelheim Investigational Site

City

Yangsan

Country

Korea, Republic of

Facility Name

1220.48.3503 Boehringer Ingelheim Investigational Site

City

Aveiro

Country

Portugal

Facility Name

1220.48.3509 Boehringer Ingelheim Investigational Site

City

Barreiro

Country

Portugal

Facility Name

1220.48.3501 Boehringer Ingelheim Investigational Site

City

Lisboa

Country

Portugal

Facility Name

1220.48.3502 Boehringer Ingelheim Investigational Site

City

Porto

Country

Portugal

Facility Name

1220.48.4002 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1220.48.7001 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1220.48.7004 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1220.48.3406 Boehringer Ingelheim Investigational Site

City

A Coruña

Country

Spain

Facility Name

1220.48.3402 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1220.48.3404 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1220.48.3411 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1220.48.3412 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1220.48.3405 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1220.48.3409 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1220.48.3410 Boehringer Ingelheim Investigational Site

City

Majadahonda-Madrid

Country

Spain

Facility Name

1220.48.3403 Boehringer Ingelheim Investigational Site

City

Sevilla

Country

Spain

Facility Name

1220.48.3401 Boehringer Ingelheim Investigational Site

City

Valencia

Country

Spain

Facility Name

1220.48.4106 Boehringer Ingelheim Investigational Site

City

Bern

Country

Switzerland

Facility Name

1220.48.8802 China Medical University Hospital

City

Taichung

Country

Taiwan

Facility Name

1220.48.4405 Boehringer Ingelheim Investigational Site

City

Bristol

Country

United Kingdom

Facility Name

1220.48.4409 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1220.48.4401 Boehringer Ingelheim Investigational Site

City

Manchester

Country

United Kingdom

Facility Name

1220.48.4408 Boehringer Ingelheim Investigational Site

City

Nottingham

Country

United Kingdom

Facility Name

1220.48.4407 Boehringer Ingelheim Investigational Site

City

Oxford

Country

United Kingdom

Facility Name

1220.48.4403 Boehringer Ingelheim Investigational Site

City

Southampton

Country

United Kingdom

Facility Name

1220.48.4404 Boehringer Ingelheim Investigational Site

City

Tooting, London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

26572686

Citation

Foster GR, Ferenci P, Asselah T, Mantry P, Dufour JF, Bourliere M, Forton D, Maevskaya M, Wright D, Yoshida EM, Garcia-Samaniego J, Oliveira C, Wright M, Warner N, Sha N, Quinson AM, Stern JO. Open-label study of faldaprevir plus peginterferon and ribavirin in hepatitis C virus genotype 1-infected patients who failed placebo plus peginterferon and ribavirin. J Viral Hepat. 2016 Mar;23(3):227-31. doi: 10.1111/jvh.12485. Epub 2015 Nov 17.

Results Reference

derived

Links:

URL

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

Description

Related Info

Learn more about this trial

A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

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A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

Hepatitis C

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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