Hepatitis CPhase 3NCT01330316

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

A Phase 3 study testing BI 201335 and PegIFN/RBV in people with Hepatitis C, run by Boehringer Ingelheim at 87 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C
What is being tested?: BI 201335 and PegIFN/RBV
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 87 sitesin 15 countries
Study dates: Jul 2011to Jun 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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,

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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.

Who cannot join

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

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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.

Trial locations and contacts

87 sites in 15 countries.

Country

City, postcode or hospital

87 sites in 15 countries

United States20 sites

1220.48.0063 Boehringer Ingelheim Investigational Site
Arlington, Texas
1220.48.0029 Boehringer Ingelheim Investigational Site
Austin, Texas
1220.48.0087 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
1220.48.0004 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1220.48.0013 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1220.48.0039 Boehringer Ingelheim Investigational Site
Columbus, Georgia
1220.48.0017 Boehringer Ingelheim Investigational Site
Dallas, Texas
1220.48.0071 Boehringer Ingelheim Investigational Site
Dallas, Texas
1220.48.0078 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1220.48.0081 Boehringer Ingelheim Investigational Site
Forth Worth, Texas
1220.48.0027 Boehringer Ingelheim Investigational Site
Framingham, Massachusetts
1220.48.0011 Boehringer Ingelheim Investigational Site
Los Angeles, California
1220.48.0066 Boehringer Ingelheim Investigational Site
Neptune City, New Jersey
1220.48.0012 Boehringer Ingelheim Investigational Site
New York, New York
1220.48.0091 Boehringer Ingelheim Investigational Site
North Little Rock, Arkansas
1220.48.0018 Boehringer Ingelheim Investigational Site
Oceanside, California
1220.48.0095 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida
1220.48.0058 Boehringer Ingelheim Investigational Site
Portland, Oregon
1220.48.0065 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts
1220.48.0023 Boehringer Ingelheim Investigational Site
Tupelo, Mississippi

Other trials in United States

Spain10 sites

1220.48.3406 Boehringer Ingelheim Investigational Site
A Coruña
1220.48.3402 Boehringer Ingelheim Investigational Site
Barcelona
1220.48.3404 Boehringer Ingelheim Investigational Site
Barcelona
1220.48.3411 Boehringer Ingelheim Investigational Site
Barcelona
1220.48.3412 Boehringer Ingelheim Investigational Site
Barcelona
1220.48.3405 Boehringer Ingelheim Investigational Site
Madrid
1220.48.3409 Boehringer Ingelheim Investigational Site
Madrid
1220.48.3410 Boehringer Ingelheim Investigational Site
Majadahonda-Madrid
1220.48.3403 Boehringer Ingelheim Investigational Site
Seville
1220.48.3401 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

Germany9 sites

1220.48.4902 Boehringer Ingelheim Investigational Site
Berlin
1220.48.4904 Boehringer Ingelheim Investigational Site
Berlin
1220.48.4913 Boehringer Ingelheim Investigational Site
Dortmund
1220.48.4906 Boehringer Ingelheim Investigational Site
Düsseldorf
1220.48.4901 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1220.48.4908 Boehringer Ingelheim Investigational Site
Hamburg
1220.48.4914 Boehringer Ingelheim Investigational Site
Kiel
1220.48.4911 Boehringer Ingelheim Investigational Site
Mainz
1220.48.4905 Boehringer Ingelheim Investigational Site
München

Other trials in Germany

Japan8 sites

1220.48.8106 Boehringer Ingelheim Investigational Site
Chiba, Chiba
1220.48.8117 Boehringer Ingelheim Investigational Site
Kita-gun, Kagawa
1220.48.8116 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama
1220.48.8118 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka
1220.48.8113 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1220.48.8114 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo
1220.48.8119 Boehringer Ingelheim Investigational Site
Omura, Nagasaki
1220.48.8121 Boehringer Ingelheim Investigational Site
Osaka, Osaka

Other trials in Japan

Canada7 sites

1220.48.1012 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1220.48.1005 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1220.48.1006 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1220.48.1003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1220.48.1016 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1220.48.1007 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
1220.48.1009 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

France7 sites

1220.48.3301 Boehringer Ingelheim Investigational Site
Clichy
1220.48.3311 Boehringer Ingelheim Investigational Site
Lille
1220.48.3303 Boehringer Ingelheim Investigational Site
Marseille
1220.48.3304 Boehringer Ingelheim Investigational Site
Montpellier
1220.48.3305 Boehringer Ingelheim Investigational Site
Nice
1220.48.3316 Boehringer Ingelheim Investigational Site
Pessac
1220.48.3312 Boehringer Ingelheim Investigational Site
Saint-Laurent-du-Var

Other trials in France

United Kingdom7 sites

1220.48.4405 Boehringer Ingelheim Investigational Site
Bristol
1220.48.4409 Boehringer Ingelheim Investigational Site
London
1220.48.4401 Boehringer Ingelheim Investigational Site
Manchester
1220.48.4408 Boehringer Ingelheim Investigational Site
Nottingham
1220.48.4407 Boehringer Ingelheim Investigational Site
Oxford
1220.48.4403 Boehringer Ingelheim Investigational Site
Southampton
1220.48.4404 Boehringer Ingelheim Investigational Site
Tooting, London

Other trials in United Kingdom

South Korea5 sites

1220.48.8204 Boehringer Ingelheim Investigational Site
Pusan
1220.48.8205 Boehringer Ingelheim Investigational Site
Pusan
1220.48.8206 Boehringer Ingelheim Investigational Site
Seoul
1220.48.8207 Boehringer Ingelheim Investigational Site
Seoul
1220.48.8201 Boehringer Ingelheim Investigational Site
Yangsan

Other trials in South Korea

Portugal4 sites

1220.48.3503 Boehringer Ingelheim Investigational Site
Aveiro
1220.48.3509 Boehringer Ingelheim Investigational Site
Barreiro
1220.48.3501 Boehringer Ingelheim Investigational Site
Lisbon
1220.48.3502 Boehringer Ingelheim Investigational Site
Porto

Other trials in Portugal

Belgium3 sites

1220.48.3201 Boehringer Ingelheim Investigational Site
Brussels
1220.48.3204 Boehringer Ingelheim Investigational Site
Edegem
1220.48.3203 Boehringer Ingelheim Investigational Site
Liège

Other trials in Belgium

Austria2 sites

1220.48.4301 Boehringer Ingelheim Investigational Site
Vienna
1220.48.4302 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

Russia2 sites

1220.48.7001 Boehringer Ingelheim Investigational Site
Moscow
1220.48.7004 Boehringer Ingelheim Investigational Site
Moscow

Other trials in Russia

Romania1 site

1220.48.4002 Boehringer Ingelheim Investigational Site
Bucharest

Other trials in Romania

Switzerland1 site

1220.48.4106 Boehringer Ingelheim Investigational Site
Bern

Other trials in Switzerland

Taiwan1 site

1220.48.8802 China Medical University Hospital
Taichung

Other trials in Taiwan

About this study

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

Conditions: Hepatitis C
Being tested: BI 201335, PegIFN/RBV
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 201335Drug
BI 201335 for 24 weeks
PegIFN/RBVDrug
PegIFN/RBV for 48 weeks

Study groups in NCT01330316
Study group	Role	What they receive
BI 201335 for 24 weeks	Experimental	BI 201335 once daily dose for 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks Receives: Drug: BI 201335; Drug: PegIFN/RBV

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks post treatment, up to 60 weeks

Secondary outcomes (15)

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.
Measured: 24 weeks post treatment, up to 72 weeks
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.
Measured: week 4 and 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.
Measured: Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers
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.
Measured: 48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS
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.
Measured: Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.
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.
Measured: Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers
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.
Measured: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
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.
Measured: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
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.
Measured: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
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.
Measured: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
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.
Measured: baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study
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.
Measured: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
Changes From Baseline in Laboratory Test Values Over Time [ALT]
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 ALT is presented.
Measured: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
Changes From Baseline in Laboratory Test Values Over Time [AST]
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 AST is presented.
Measured: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total]
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 Bilirubin total is presented.
Measured: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Jun 2014

First posted6 Apr 2011 (estimated)
Study startJul 2011
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01330316
Sponsor's protocol ID: 1220.48
Other IDs: 2011-000141-20
Status last verified: May 2016
First submitted: 5 Apr 2011
Last updated: 30 Jun 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 26572686

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
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People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01330316
Acronym / sponsor ID: 1220.48
Conditions: Hepatitis C
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 6 Apr 2011 (estimated)
Results: Posted 31 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BI 201335 for 24 weeks	Experimental	Drug: BI 201335, Drug: PegIFN/RBVBI 201335 once daily dose for 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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:
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.

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 201335BI 201335 for 24 weeks	Drug	BI 201335 for 24 weeks
PegIFN/RBVPegIFN/RBV for 48 weeks	Drug	BI 201335 for 24 weeks

Primary outcome

Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL
Time frame: 12 weeks post treatment, up to 60 weeks
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.

15 secondary outcomes

Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
Time frame: 24 weeks post treatment, up to 72 weeks
Early Treatment Success (ETS)
Time frame: week 4 and week 8
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT)
Time frame: Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment.
Time frame: 48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT)
Time frame: Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment.
Time frame: Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers
Occurrence of Adverse Events (Overall and by DAIDS Grade)
Time frame: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
Occurrence of Adverse Events Leading to Treatment Discontinuation
Time frame: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
Occurrence of Serious Adverse Events (SAEs)
Time frame: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
Occurrence of Drug-related AEs as Assessed by the Investigator
Time frame: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
Laboratory Test Abnormalities by DAIDS Grades
Time frame: baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study
Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin]
Time frame: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
Changes From Baseline in Laboratory Test Values Over Time [ALT]
Time frame: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
Changes From Baseline in Laboratory Test Values Over Time [AST]
Time frame: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total]
Time frame: baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)

Results and safety

Results posted to the registry on 31 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Relapse	43	41
Non-relapse	75	60

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

Time frame: 12 weeks post treatment, up to 60 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Relapse n = 43	Non-relapse n = 75
Value	95.3 (89.1 to 100)	54.7 (43.4 to 65.9)

Population analysed: FAS

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Relapse	1 of 43 (2.3%)	38 of 43 (88.4%)	Not reported
Non-relapse	6 of 75 (8%)	68 of 75 (90.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26572686Foster 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.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

87 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 201335 and PegIFN/RBV in people with Hepatitis C, run by Boehringer Ingelheim at 87 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Spain, Germany, Japan, Canada and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL (time frame: 12 weeks post treatment, up to 60 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01330316, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.