Hepatitis CPhase 3NCT01343888

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

A Phase 3 study testing PegIFN/RBV and BI 201335 in people with Hepatitis C, run by Boehringer Ingelheim at 98 sites in 11 countries.

Completed

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

Official record

Search all trials

Trial summary

The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone. 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?: PegIFN/RBV and BI 201335
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 656 participants
Where: 98 sitesin 11 countries
Study dates: Apr 2011to Mar 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, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:
positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
liver biopsy consistent with chronic HCV infection.
HCV genotype 1 infection confirmed by genotypic testing at screening.
Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
HCV RNA = 1,000 IU/mL at screening

Show all 20Show fewer

Documentation of a liver biopsy within 3 years or fibroscan within 6 months prior to randomization.
Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before randomization need not be repeated. Biopsies may be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy in patients at risk for the procedure should not exclude such patients from a trial.
Age 18 to 70 years
Female patients:
with documented hysterectomy,
who have had both ovaries removed,
with documented tubal ligation,
who are post-menopausal with last menstrual period at least 12 months prior to screening, or
of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin.
Medically accepted methods of contraception for females in this trial are ethinyl estradiol containing contraceptives, diaphragm with spermicide substance and intra-uterine device.
Male patients:
who are documented to be sterile, or
who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. Female partners of childbearing potential should perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).
Signed informed consent form prior to trial participation

Who cannot join

HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criterion.
HIV co-infection
Hepatitis B virus (HBV) infection based on presence of HBs-Ag
Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months

Show all 13Show fewer

A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patients ability to participate in this study
Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study.
Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to randomization. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened.
Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to randomization and throughout the treatment phase of this trial.
Known hypersensitivity to any ingredient of the study drugs.
Alpha fetoprotein value > 100 ng/mL at screening; if > 20 ng/mL and = 100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2).
Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.

Trial locations and contacts

98 sites in 11 countries.

Country

City, postcode or hospital

98 sites in 11 countries

Japan20 sites

1220.30.8106 Boehringer Ingelheim Investigational Site
Chiba, Chiba
1220.30.8111 Boehringer Ingelheim Investigational Site
Gifu, Gifu
1220.30.8107 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo
1220.30.8112 Boehringer Ingelheim Investigational Site
Izunokuni, Shizuoka
1220.30.8108 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa
1220.30.8117 Boehringer Ingelheim Investigational Site
Kita-gun, Kagawa
1220.30.8109 Boehringer Ingelheim Investigational Site
Kofu, Yamanashi
1220.30.8116 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama
1220.30.8118 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka
1220.30.8110 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano
1220.30.8113 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1220.30.8105 Boehringer Ingelheim Investigational Site
Namegata, Ibaraki
1220.30.8114 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo
1220.30.8119 Boehringer Ingelheim Investigational Site
Omura, Nagasaki
1220.30.8122 Boehringer Ingelheim Investigational Site
Omuta, Fukuoka
1220.30.8121 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1220.30.8101 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1220.30.8102 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
1220.30.8115 Boehringer Ingelheim Investigational Site
Tanabe, Wakayama
1220.30.8104 Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki

Other trials in Japan

Germany16 sites

1220.30.4917 Boehringer Ingelheim Investigational Site
Aachen
1220.30.4902 Boehringer Ingelheim Investigational Site
Berlin
1220.30.4904 Boehringer Ingelheim Investigational Site
Berlin
1220.30.4916 Boehringer Ingelheim Investigational Site
Bonn
1220.30.4913 Boehringer Ingelheim Investigational Site
Dortmund
1220.30.4906 Boehringer Ingelheim Investigational Site
Düsseldorf
1220.30.4909 Boehringer Ingelheim Investigational Site
Düsseldorf
1220.30.4912 Boehringer Ingelheim Investigational Site
Erlangen
1220.30.4901 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1220.30.4908 Boehringer Ingelheim Investigational Site
Hamburg
1220.30.4907 Boehringer Ingelheim Investigational Site
Herne
1220.30.4914 Boehringer Ingelheim Investigational Site
Kiel
1220.30.4903 Boehringer Ingelheim Investigational Site
Leipzig
1220.30.4911 Boehringer Ingelheim Investigational Site
Mainz
1220.30.4905 Boehringer Ingelheim Investigational Site
München
1220.30.4915 Boehringer Ingelheim Investigational Site
Ulm

Other trials in Germany

France12 sites

1220.30.3314 Boehringer Ingelheim Investigational Site
Clermont-Ferrand
1220.30.3301 Boehringer Ingelheim Investigational Site
Clichy
1220.30.3311 Boehringer Ingelheim Investigational Site
Lille
1220.30.3303 Boehringer Ingelheim Investigational Site
Marseille
1220.30.3304 Boehringer Ingelheim Investigational Site
Montpellier
1220.30.3305 Boehringer Ingelheim Investigational Site
Nice
1220.30.3302 Boehringer Ingelheim Investigational Site
Paris
1220.30.3309 Boehringer Ingelheim Investigational Site
Paris
1220.30.3316 Boehringer Ingelheim Investigational Site
Pessac
1220.30.3315 Boehringer Ingelheim Investigational Site
Rennes
1220.30.3312 Boehringer Ingelheim Investigational Site
Saint-Laurent-du-Var
1220.30.3313 Boehringer Ingelheim Investigational Site
Toulouse

Other trials in France

United Kingdom9 sites

1220.30.4405 Boehringer Ingelheim Investigational Site
Bristol
1220.30.4404 Boehringer Ingelheim Investigational Site
London
1220.30.4409 Boehringer Ingelheim Investigational Site
London
1220.30.4410 Boehringer Ingelheim Investigational Site
London
1220.30.4401 Boehringer Ingelheim Investigational Site
Manchester
1220.30.4408 Boehringer Ingelheim Investigational Site
Nottingham
1220.30.4407 Boehringer Ingelheim Investigational Site
Oxford
1220.30.4403 Boehringer Ingelheim Investigational Site
Southampton
1220.30.4406 Boehringer Ingelheim Investigational Site
Whitechapel, London

Other trials in United Kingdom

Portugal8 sites

1220.30.3503 Boehringer Ingelheim Investigational Site
Aveiro
1220.30.3509 Boehringer Ingelheim Investigational Site
Barreiro
1220.30.3506 Boehringer Ingelheim Investigational Site
Coimbra
1220.30.3501 Boehringer Ingelheim Investigational Site
Lisbon
1220.30.3505 Boehringer Ingelheim Investigational Site
Lisbon
1220.30.3507 Boehringer Ingelheim Investigational Site
Lisbon
1220.30.3502 Boehringer Ingelheim Investigational Site
Porto
1220.30.3504 Boehringer Ingelheim Investigational Site
Vila Real

Other trials in Portugal

Spain8 sites

1220.30.3406 Boehringer Ingelheim Investigational Site
A Coruña
1220.30.3402 Boehringer Ingelheim Investigational Site
Barcelona
1220.30.3404 Boehringer Ingelheim Investigational Site
Barcelona
1220.30.3405 Boehringer Ingelheim Investigational Site
Madrid
1220.30.3408 Boehringer Ingelheim Investigational Site
Santander
1220.30.3403 Boehringer Ingelheim Investigational Site
Seville
1220.30.3401 Boehringer Ingelheim Investigational Site
Valencia
1220.30.3407 Boehringer Ingelheim Investigational Site
Vigo (Pontevedra)

Other trials in Spain

Belgium6 sites

1220.30.3201 Boehringer Ingelheim Investigational Site
Brussels
1220.30.3207 Boehringer Ingelheim Investigational Site
Brussels
1220.30.3204 Boehringer Ingelheim Investigational Site
Edegem
1220.30.3205 Boehringer Ingelheim Investigational Site
Ghent
1220.30.3202 Boehringer Ingelheim Investigational Site
Leuven
1220.30.3203 Boehringer Ingelheim Investigational Site
Liège

Other trials in Belgium

Russia6 sites

1220.30.7002 Boehringer Ingelheim Investigational Site
Chelyabinsk
1220.30.7001 Boehringer Ingelheim Investigational Site
Moscow
1220.30.7004 Boehringer Ingelheim Investigational Site
Moscow
1220.30.7005 Boehringer Ingelheim Investigational Site
Moscow
1220.30.7006 Boehringer Ingelheim Investigational Site
Saint Petersburg
1220.30.7007 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

Switzerland5 sites

1220.30.4106 Boehringer Ingelheim Investigational Site
Bern
1220.30.4103 Boehringer Ingelheim Investigational Site
La Chaux-de-Fonds
1220.30.4107 Boehringer Ingelheim Investigational Site
Lugano
1220.30.4108 Boehringer Ingelheim Investigational Site
Sankt Gallen
1220.30.4101 Boehringer Ingelheim Investigational Site
Zurich

Other trials in Switzerland

Austria4 sites

1220.30.4303 Boehringer Ingelheim Investigational Site
Linz
1220.30.4301 Boehringer Ingelheim Investigational Site
Vienna
1220.30.4302 Boehringer Ingelheim Investigational Site
Vienna
1220.30.4304 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

Romania4 sites

1220.30.4001 Boehringer Ingelheim Investigational Site
Bucharest
1220.30.4002 Boehringer Ingelheim Investigational Site
Bucharest
1220.30.4003 Boehringer Ingelheim Investigational Site
Bucharest
1220.30.4004 Boehringer Ingelheim Investigational Site
Bucharest

Other trials in Romania

About this study

Official title: A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection

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

What participants receive

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

PegIFN/RBVDrug
PegIFN/RBV for 48 weeks
BI 201335Drug
BI 201335 once daily high dose
BI 201335Drug
BI 201335 once daily low dose
PlaceboDrug

Study groups in NCT01343888
Study group	Role	What they receive
PegIFN/RBV	Active comparator	PegIFN/RBV for 48 weeks Receives: Drug: PegIFN/RBV
BI 201335 for 12 or 24 weeks	Experimental	BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks Receives: Drug: PegIFN/RBV; Drug: BI 201335
Placebo and PegIFN/RBV	Active comparator	Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48. Receives: Drug: PegIFN/RBV; Drug: Placebo

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)
Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level < 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Measured: 12 weeks post treatment, up to 60 weeks

Secondary outcomes (10)

Sustained Virological Response 24 Weeks Post-treatment (SVR24)
Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Measured: 24 weeks post treatment, up to 72 weeks
Early Treatment Success (ETS)
Early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.
Measured: week 4 and week 8
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Measured: 12 weeks post treatment, up to 60 weeks
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Measured: 12 weeks post treatment, up to 60 weeks
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
This will be presented as the number of patients. BL = Baseline
Measured: 12 weeks post treatment, up to 60 weeks
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
This will be presented as the number of patients. BL = Baseline
Measured: 12 weeks post treatment, up to 60 weeks
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Measured: 12 weeks post treatment, up to 60 weeks
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Measured: 12 weeks post treatment, up to 60 weeks
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
This will be presented as the number of patients. BL = Baseline
Measured: 12 weeks post treatment, up to 60 weeks
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
This will be presented as the number of patients. BL = Baseline
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.

Apr 2011Mar 2014

First posted28 Apr 2011 (estimated)
Study startApr 2011
Primary completionMar 2014
Study completionMar 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 (3)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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 656 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01343888
Sponsor's protocol ID: 1220.30
Other IDs: 2010-021716-42
Status last verified: Aug 2015
First submitted: 20 Apr 2011
Last updated: 18 Sep 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Jensen DM, Asselah T, Dieterich D, Foster GR, Sulkowski MS, Zeuzem S, Mantry P, Yoshida EM, Moreno C, Ouzan D, Wright M, Morano LE, Buynak R, Bourliere M, Hassanein T, Nishiguchi S, Kao JH, Omata M, Paik SW, Wong DK, Tam E, Kaita K, Feinman SV, Stern JO, Scherer J, Quinson AM, Voss F, Gallivan JP, Bocher WO, Ferenci P. Faldaprevir, pegylated interferon, and ribavirin for treatment-naive HCV genotype-1: pooled analysis of two phase 3 trials. Ann Hepatol. 2016 May-Jun;15(3):333-49. doi: 10.5604/16652681.1198803.
PubMed 27049487
Dieterich D, Nelson M, Soriano V, Arasteh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon alpha-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.
PubMed 25710287
Ferenci P, Asselah T, Foster GR, Zeuzem S, Sarrazin C, Moreno C, Ouzan D, Maevskaya M, Calinas F, Morano LE, Crespo J, Dufour JF, Bourliere M, Agarwal K, Forton D, Schuchmann M, Zehnter E, Nishiguchi S, Omata M, Kukolj G, Datsenko Y, Garcia M, Scherer J, Quinson AM, Stern JO; STARTVerso1 Study Group. STARTVerso1: A randomized trial of faldaprevir plus pegylated interferon/ribavirin for chronic HCV genotype-1 infection. J Hepatol. 2015 Jun;62(6):1246-55. doi: 10.1016/j.jhep.2014.12.024. Epub 2015 Jan 2.
PubMed 25559324

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
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B

All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2015. 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 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection
ClinicalTrials.gov ID: NCT01343888
Acronym / sponsor ID: 1220.30
Conditions: Hepatitis C
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 656 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 28 Apr 2011 (estimated)
Results: Posted 18 Sep 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
Number of arms: 3

Arm	Type	Receives
PegIFN/RBV	Active comparator	Drug: PegIFN/RBVPegIFN/RBV for 48 weeks
BI 201335 for 12 or 24 weeks	Experimental	Drug: PegIFN/RBV, Drug: BI 201335BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
Placebo and PegIFN/RBV	Active comparator	Drug: PegIFN/RBV, Drug: PlaceboPlacebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.

Who may qualify

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

Key inclusion criteria (20 listed)

Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:
HCV genotype 1 infection confirmed by genotypic testing at screening.
Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
HCV RNA = 1,000 IU/mL at screening
Documentation of a liver biopsy within 3 years or fibroscan within 6 months prior to randomization.

Key exclusion criteria (13 listed)

HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criterion.
HIV co-infection
Hepatitis B virus (HBV) infection based on presence of HBs-Ag
Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)

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
PegIFN/RBVPegIFN/RBV for 48 weeks	Drug	BI 201335 for 12 or 24 weeks, PegIFN/RBV, Placebo and PegIFN/RBV
BI 201335BI 201335 once daily high dose	Drug	BI 201335 for 12 or 24 weeks
BI 201335BI 201335 once daily low dose	Drug	BI 201335 for 12 or 24 weeks
Placebo	Drug	Placebo and PegIFN/RBV

Primary outcome

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

10 secondary outcomes

Sustained Virological Response 24 Weeks Post-treatment (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) When SVR12=YES
Time frame: 12 weeks post treatment, up to 60 weeks
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO
Time frame: 12 weeks post treatment, up to 60 weeks
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Time frame: 12 weeks post treatment, up to 60 weeks
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
Time frame: 12 weeks post treatment, up to 60 weeks
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES
Time frame: 12 weeks post treatment, up to 60 weeks
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO
Time frame: 12 weeks post treatment, up to 60 weeks
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Time frame: 12 weeks post treatment, up to 60 weeks
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
Time frame: 12 weeks post treatment, up to 60 weeks

Results and safety

Results posted to the registry on 18 Sep 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
Faldaprevir 120mg and PegIFN/RBV	259	234
Faldaprevir 240mg and PegIFN/RBV	261	222
Placebo and PegIFN/RBV	132	110

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	Faldaprevir 120mg and PegIFN/RBV n = 259	Faldaprevir 240mg and PegIFN/RBV n = 261	Placebo and PegIFN/RBV n = 132
Value	79.5 (74.6 to 84.4)	80.5 (75.6 to 85.3)	52.3 (43.8 to 60.8)

Faldaprevir 120mg and PegIFN/RBV vs Placebo and PegIFN/RBV: Koch's method: 27.5 (95% CI 17.9 to 37.0), p <0.0001, Cochran-Mantel-Haenszel
Faldaprevir 240mg and PegIFN/RBV vs Placebo and PegIFN/RBV: Koch's methond: 28.6 (95% CI 19.0 to 38.2), p <0.0001, Cochran-Mantel-Haenszel
Faldaprevir 120mg and PegIFN/RBV vs Faldaprevir 240mg and PegIFN/RBV: Koch's method: -1.0 (95% CI -7.9 to 5.8)

Population analysed: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Faldaprevir 120mg and PegIFN/RBV	17 of 259 (6.6%)	246 of 259 (95%)	Not reported
Faldaprevir 240mg and PegIFN/RBV	17 of 261 (6.5%)	250 of 261 (95.8%)	Not reported
Placebo and PegIFN/RBV	8 of 132 (6.1%)	120 of 132 (90.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27049487Jensen DM, Asselah T, Dieterich D, Foster GR, Sulkowski MS, Zeuzem S, Mantry P, Yoshida EM, Moreno C, Ouzan D, Wright M, Morano LE, Buynak R, Bourliere M, Hassanein T, Nishiguchi S, Kao JH, Omata M, Paik SW, Wong DK, Tam E, Kaita K, Feinman SV, Stern JO, Scherer J, Quinson AM, Voss F, Gallivan JP, Bocher WO, Ferenci P. Faldaprevir, pegylated interferon, and ribavirin for treatment-naive HCV genotype-1: pooled analysis of two phase 3 trials. Ann Hepatol. 2016 May-Jun;15(3):333-49. doi: 10.5604/16652681.1198803.
Derived from this study: PubMed 25710287Dieterich D, Nelson M, Soriano V, Arasteh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon alpha-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.
Derived from this study: PubMed 25559324Ferenci P, Asselah T, Foster GR, Zeuzem S, Sarrazin C, Moreno C, Ouzan D, Maevskaya M, Calinas F, Morano LE, Crespo J, Dufour JF, Bourliere M, Agarwal K, Forton D, Schuchmann M, Zehnter E, Nishiguchi S, Omata M, Kukolj G, Datsenko Y, Garcia M, Scherer J, Quinson AM, Stern JO; STARTVerso1 Study Group. STARTVerso1: A randomized trial of faldaprevir plus pegylated interferon/ribavirin for chronic HCV genotype-1 infection. J Hepatol. 2015 Jun;62(6):1246-55. doi: 10.1016/j.jhep.2014.12.024. Epub 2015 Jan 2.
Related InfoLink provided by the sponsor.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B

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

98 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PegIFN/RBV and BI 201335 in people with Hepatitis C, run by Boehringer Ingelheim at 98 sites in 11 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 20 inclusion and 13 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 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in Japan, Germany, France, United Kingdom, Portugal and 6 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 18 Sep 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 NCT01343888, which also lists 3 linked publications.

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 18 Sep 2015; AzTrials last refreshed its copy on 8 Nov 2026.