Hepatitis C, ChronicPhase 3NCT01358864

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

A Phase 3 study testing BI 201335, Pegylated Interferon-alpha (IFN) and Ribavirin (RBV) in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 116 sites in 12 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 aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: BI 201335, Pegylated Interferon-alpha (IFN) and Ribavirin (RBV)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 678 participants
Where: 116 sitesin 12 countries
Study dates: Jun 2011to May 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 genotype 1 infection, diagnosed at least 6 months prior to screening
Confirmed prior virological failure with an approved dose of PegIFN/RBV
Age 18 to 70 years,
HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

Who cannot join

HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
Decompensated liver disease, or history of decompensated liver disease,
Body weight < 40 or > 125 kg,
Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study

Show all 9Show fewer

Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
Hemoglobin < 12 g/dL for women and < 13 g/dL for men
Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,

Trial locations and contacts

116 sites in 12 countries.

Country

City, postcode or hospital

116 sites in 12 countries

Japan24 sites

1220.7.8106 Boehringer Ingelheim Investigational Site
Chiba, Chiba
1220.7.8111 Boehringer Ingelheim Investigational Site
Gifu, Gifu
1220.7.8107 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo
1220.7.8112 Boehringer Ingelheim Investigational Site
Izunokuni, Shizuoka
1220.7.8108 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa
1220.7.8117 Boehringer Ingelheim Investigational Site
Kita-gun, Kagawa
1220.7.8109 Boehringer Ingelheim Investigational Site
Kofu, Yamanashi
1220.7.8116 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama
1220.7.8118 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka
1220.7.8110 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano
1220.7.8124 Boehringer Ingelheim Investigational Site
Matsuyama, Ehime
1220.7.8113 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1220.7.8105 Boehringer Ingelheim Investigational Site
Namegata, Ibaraki
1220.7.8114 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo
1220.7.8125 Boehringer Ingelheim Investigational Site
Ogaki, Gifu
1220.7.8119 Boehringer Ingelheim Investigational Site
Omura, Nagasaki
1220.7.8122 Boehringer Ingelheim Investigational Site
Omuta, Fukuoka
1220.7.8121 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1220.7.8101 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1220.7.8102 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
1220.7.8115 Boehringer Ingelheim Investigational Site
Tanabe, Wakayama
1220.7.8123 Boehringer Ingelheim Investigational Site
Toyama,Toyama
1220.7.8126 Boehringer Ingelheim Investigational Site
Tsu, Mie
1220.7.8104 Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki

Other trials in Japan

United States18 sites

1220.7.0063 Boehringer Ingelheim Investigational Site
Arlington, Texas
1220.7.0029 Boehringer Ingelheim Investigational Site
Austin, Texas
1220.7.0085 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
1220.7.0087 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
1220.7.0013 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1220.7.0039 Boehringer Ingelheim Investigational Site
Columbus, Georgia
1220.7.0071 Boehringer Ingelheim Investigational Site
Dallas, Texas
1220.7.0082 Boehringer Ingelheim Investigational Site
Englewood, Colorado
1220.7.0027 Boehringer Ingelheim Investigational Site
Framingham, Massachusetts
1220.7.0009 Boehringer Ingelheim Investigational Site
Houston, Texas
1220.7.0101 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
1220.7.0012 Boehringer Ingelheim Investigational Site
New York, New York
1220.7.0091 Boehringer Ingelheim Investigational Site
North Little Rock, Arkansas
1220.7.0095 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida
1220.7.0058 Boehringer Ingelheim Investigational Site
Portland, Oregon
1220.7.0016 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1220.7.0062 Boehringer Ingelheim Investigational Site
Vaiparaiso, Indiana
1220.7.0077 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

France12 sites

1220.7.3301 Boehringer Ingelheim Investigational Site
Clichy
1220.7.3311 Boehringer Ingelheim Investigational Site
Lille
1220.7.3303 Boehringer Ingelheim Investigational Site
Marseille
1220.7.3304 Boehringer Ingelheim Investigational Site
Montpellier
1220.7.3305 Boehringer Ingelheim Investigational Site
Nice
1220.7.3302 Boehringer Ingelheim Investigational Site
Paris
1220.7.3310 Boehringer Ingelheim Investigational Site
Paris
1220.7.3316 Boehringer Ingelheim Investigational Site
Pessac
1220.7.3317 Boehringer Ingelheim Investigational Site
Reims
1220.7.3315 Boehringer Ingelheim Investigational Site
Rennes
1220.7.3318 Boehringer Ingelheim Investigational Site
Strasbourg
1220.7.3308 Boehringer Ingelheim Investigational Site
Vandœuvre-lès-Nancy

Other trials in France

Spain12 sites

1220.7.3406 Boehringer Ingelheim Investigational Site
A Coruña
1220.7.3402 Boehringer Ingelheim Investigational Site
Barcelona
1220.7.3404 Boehringer Ingelheim Investigational Site
Barcelona
1220.7.3411 Boehringer Ingelheim Investigational Site
Barcelona
1220.7.3412 Boehringer Ingelheim Investigational Site
Barcelona
1220.7.3405 Boehringer Ingelheim Investigational Site
Madrid
1220.7.3409 Boehringer Ingelheim Investigational Site
Madrid
1220.7.3410 Boehringer Ingelheim Investigational Site
Majadahonda-Madrid
1220.7.3408 Boehringer Ingelheim Investigational Site
Santander
1220.7.3403 Boehringer Ingelheim Investigational Site
Seville
1220.7.3401 Boehringer Ingelheim Investigational Site
Valencia
1220.7.3407 Boehringer Ingelheim Investigational Site
Vigo (Pontevedra)

Other trials in Spain

Germany11 sites

1220.7.4902 Boehringer Ingelheim Investigational Site
Berlin
1220.7.4904 Boehringer Ingelheim Investigational Site
Berlin
1220.7.4913 Boehringer Ingelheim Investigational Site
Dortmund
1220.7.4906 Boehringer Ingelheim Investigational Site
Düsseldorf
1220.7.4901 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1220.7.4908 Boehringer Ingelheim Investigational Site
Hamburg
1220.7.4918 Boehringer Ingelheim Investigational Site
Hanover
1220.7.4907 Boehringer Ingelheim Investigational Site
Herne
1220.7.4903 Boehringer Ingelheim Investigational Site
Leipzig
1220.7.4911 Boehringer Ingelheim Investigational Site
Mainz
1220.7.4905 Boehringer Ingelheim Investigational Site
München

Other trials in Germany

Canada9 sites

1220.7.1011 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1220.7.1012 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1220.7.1010 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1220.7.1014 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1220.7.1004 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1220.7.1006 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1220.7.1003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1220.7.1016 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1220.7.1007 Boehringer Ingelheim Investigational Site
Victoria, British Columbia

Other trials in Canada

United Kingdom8 sites

1220.7.4405 Boehringer Ingelheim Investigational Site
Bristol
1220.7.4404 Boehringer Ingelheim Investigational Site
London
1220.7.4409 Boehringer Ingelheim Investigational Site
London
1220.7.4410 Boehringer Ingelheim Investigational Site
London
1220.7.4401 Boehringer Ingelheim Investigational Site
Manchester
1220.7.4408 Boehringer Ingelheim Investigational Site
Nottingham
1220.7.4407 Boehringer Ingelheim Investigational Site
Oxford
1220.7.4403 Boehringer Ingelheim Investigational Site
Southampton

Other trials in United Kingdom

Belgium7 sites

1220.7.3201 Boehringer Ingelheim Investigational Site
Brussels
1220.7.3207 Boehringer Ingelheim Investigational Site
Brussels
1220.7.3204 Boehringer Ingelheim Investigational Site
Edegem
1220.7.3205 Boehringer Ingelheim Investigational Site
Ghent
1220.7.3206 Boehringer Ingelheim Investigational Site
Jette
1220.7.3202 Boehringer Ingelheim Investigational Site
Leuven
1220.7.3203 Boehringer Ingelheim Investigational Site
Liège

Other trials in Belgium

Portugal6 sites

1220.7.3503 Boehringer Ingelheim Investigational Site
Aveiro
1220.7.3509 Boehringer Ingelheim Investigational Site
Barreiro
1220.7.3506 Boehringer Ingelheim Investigational Site
Coimbra
1220.7.3501 Boehringer Ingelheim Investigational Site
Lisbon
1220.7.3505 Boehringer Ingelheim Investigational Site
Lisbon
1220.7.3502 Boehringer Ingelheim Investigational Site
Porto

Other trials in Portugal

Switzerland5 sites

1220.7.4106 Boehringer Ingelheim Investigational Site
Bern
1220.7.4103 Boehringer Ingelheim Investigational Site
La Chaux-de-Fonds
1220.7.4107 Boehringer Ingelheim Investigational Site
Lugano
1220.7.4108 Boehringer Ingelheim Investigational Site
Sankt Gallen
1220.7.4101 Boehringer Ingelheim Investigational Site
Zurich

Other trials in Switzerland

Austria3 sites

1220.7.4303 Boehringer Ingelheim Investigational Site
Linz
1220.7.4301 Boehringer Ingelheim Investigational Site
Vienna
1220.7.4302 Boehringer Ingelheim Investigational Site
Vienna

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Puerto Rico1 site

1220.7.0034 Boehringer Ingelheim Investigational Site
San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment

Conditions: Hepatitis C, Chronic
Being tested: BI 201335, Pegylated Interferon-alpha (IFN), Ribavirin (RBV), Placebo
Medical subject headings: Hepatitis C, Chronic

What participants receive

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

BI 201335Drug
BI 201335 once a day (QD) for 24 weeks
Pegylated Interferon-alpha (IFN)Drug
Pegylated Interferon-alpha for 48 weeks
Ribavirin (RBV)Drug
Ribavirin (RBV) for 24 or 48 weeks
PlaceboDrug
Placebo to BI201335 for 24 weeks

Study groups in NCT01358864
Study group	Role	What they receive
Placebo/PegIFN/RBV	Active comparator	patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks Receives: Drug: Pegylated Interferon-alpha (IFN); Drug: Ribavirin (RBV); Drug: Placebo
BI201335 12 weeks	Experimental	patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks Receives: Drug: BI 201335; Drug: Pegylated Interferon-alpha (IFN); Drug: Ribavirin (RBV)
BI201335 24 weeks	Experimental	patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks Receives: Drug: BI 201335; Drug: Pegylated Interferon-alpha (IFN); Drug: Ribavirin (RBV)

What is being measured

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

Sustained Virological Response 12 Weeks Post Treatment (SVR12)
Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV 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 (10)

Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (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)
Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.
Measured: Week 4 and Week 8
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Measured: End of treatment, up to 48 weeks
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Measured: End of treatment, up to 48 weeks
AST Normalisation: AST in Normal Range at End of Treatment, 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
Measured: End of treatment, up to 48 weeks
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline
Measured: End of treatment, up to 48 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Measured: 12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Measured: 12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Measured: 12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Measured: 12 weeks post treatment, up to 60 weeks

Timeline

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

Jun 2011May 2014

First posted24 May 2011 (estimated)
Study startJun 2011
Primary completionFeb 2013
Study completionMay 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.
Other trials for Hepatitis C, ChronicStudies 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 678 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01358864
Sponsor's protocol ID: 1220.7
Other IDs: 2010-021715-17
Status last verified: Jul 2016
First submitted: 23 May 2011
Last updated: 29 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment
ClinicalTrials.gov ID: NCT01358864
Acronym / sponsor ID: 1220.7
Conditions: Hepatitis C, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 678 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Feb 2013 (actual)
Study completion: May 2014 (actual)
First posted: 24 May 2011 (estimated)
Results: Posted 28 Oct 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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo/PegIFN/RBV	Active comparator	Drug: Pegylated Interferon-alpha (IFN), Drug: Ribavirin (RBV), Drug: Placebopatient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
BI201335 12 weeks	Experimental	Drug: BI 201335, Drug: Pegylated Interferon-alpha (IFN), Drug: Ribavirin (RBV)patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks
BI201335 24 weeks	Experimental	Drug: BI 201335, Drug: Pegylated Interferon-alpha (IFN), Drug: Ribavirin (RBV)patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks

Who may qualify

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

Key inclusion criteria (4 listed)

Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
Confirmed prior virological failure with an approved dose of PegIFN/RBV
Age 18 to 70 years,
HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

Key exclusion criteria (9 listed)

HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
Decompensated liver disease, or history of decompensated liver disease,
Body weight < 40 or > 125 kg,
Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder

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 once a day (QD) for 24 weeks	Drug	BI201335 12 weeks, BI201335 24 weeks
Pegylated Interferon-alpha (IFN)Pegylated Interferon-alpha for 48 weeks	Drug	BI201335 12 weeks, BI201335 24 weeks, Placebo/PegIFN/RBV
Ribavirin (RBV)Ribavirin (RBV) for 24 or 48 weeks	Drug	BI201335 12 weeks, BI201335 24 weeks, Placebo/PegIFN/RBV
PlaceboPlacebo to BI201335 for 24 weeks	Drug	Placebo/PegIFN/RBV

Primary outcome

Sustained Virological Response 12 Weeks Post Treatment (SVR12)
Time frame: 12 weeks post treatment, up to 60 weeks
Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

10 secondary outcomes

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
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO
Time frame: End of treatment, up to 48 weeks
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES
Time frame: End of treatment, up to 48 weeks
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO
Time frame: End of treatment, up to 48 weeks
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES
Time frame: End of treatment, up to 48 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO
Time frame: 12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES
Time frame: 12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO
Time frame: 12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES
Time frame: 12 weeks post treatment, up to 60 weeks

Results and safety

Results posted to the registry on 28 Oct 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
Relapser:Placebo	49	18
Relapser:Faldaprevir 12 Weeks	99	86
Relapser:Faldaprevir 24 Weeks	103	87
Partial:Placebo	29	10
Partial:Faldaprevir 12 Weeks	57	46
Partial:Faldaprevir 24 Weeks	55	42
Null:Faldaprevir 12 Weeks	146	81
Null:Faldaprevir 24 Weeks	140	85

Primary outcome: Sustained Virological Response 12 Weeks Post Treatment (SVR12)

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

Measure	Relapser & Partial: Placebo n = 78	Relapser & Partial: Faldaprevir 12 Weeks n = 156	Relapser & Partial: Faldaprevir 24 Weeks n = 158	Null:Faldaprevir 12 Weeks n = 145	Null:Faldaprevir 24 Weeks n = 140
Value	10.3 (3.5 to 17.0)	65.4 (57.9 to 72.9)	61.4 (53.8 to 69.0)	33.8 (26.1 to 41.5)	32.9 (25.1 to 40.6)

Relapser & Partial: Placebo vs Relapser & Partial: Faldaprevir 12 Weeks: Adjusted percent difference: 54.7 (95% CI 44.4 to 65.0), p <0.0001, Cochran-Mantel-Haenszel
Relapser & Partial: Placebo vs Relapser & Partial: Faldaprevir 24 Weeks: Adjusted percent difference: 50.4 (95% CI 40.1 to 60.8), p <0.0001, Cochran-Mantel-Haenszel
Relapser & Partial: Faldaprevir 12 Weeks vs Relapser & Partial: Faldaprevir 24 Weeks: Adjusted percent difference: 4.5 (95% CI -5.8 to 14.9)

Population analysed: FAS

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the course of the study (48 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Relapser & Partial: Placebo	1 of 78 (1.3%)	74 of 78 (94.9%)	Not reported
Relapser & Partial: Faldaprevir 12 Weeks	14 of 156 (9%)	148 of 156 (94.9%)	Not reported
Relapser & Partial: Faldaprevir 24 Weeks	13 of 158 (8.2%)	156 of 158 (98.7%)	Not reported
Null:Faldaprevir 12 Weeks	16 of 145 (11%)	142 of 145 (97.9%)	Not reported
Null:Faldaprevir 24 Weeks	11 of 140 (7.9%)	139 of 140 (99.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
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Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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RecruitingObservational study
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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

116 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 201335, Pegylated Interferon-alpha (IFN) and Ribavirin (RBV) in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 116 sites in 12 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 4 inclusion and 9 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 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in Japan, United States, France, Spain, Germany and 7 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 28 Oct 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 12 Weeks Post Treatment (SVR12) (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 NCT01358864.

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 29 Aug 2016.