Hepatitis CPhase 3NCT01297270

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)

A Phase 3 study testing BI201335 and PegIFN/RBV in people with Hepatitis C, run by Boehringer Ingelheim at 106 sites in 5 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?: BI201335 and PegIFN/RBV
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 658 participants
Where: 106 sitesin 5 countries
Study dates: Apr 2011to Apr 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 16Show fewer

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

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.
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 17Show 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 patient¿s ability to participate in this study.
Usage of any investigational drugs within 28 days prior to screening, or planned usage of an investigational drug during the course of this study.
Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 28 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened.
Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to screening and throughout the treatment phase.
Known hypersensitivity to any ingredient of the study drugs.
Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2).
Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory results of any of the following:
International normalized ratio (INR) of =1.7
Serum Albumin =3.5 g/dL
Serum total bilirubin =2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilberts syndrome).
Pre-existing psychiatric condition that could interfere with the subject¿s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years.

Trial locations and contacts

106 sites in 5 countries.

Country

City, postcode or hospital

106 sites in 5 countries

United States78 sites

1220.47.0042 Boehringer Ingelheim Investigational Site
Annandale, Virginia
1220.47.0063 Boehringer Ingelheim Investigational Site
Arlington, Texas
1220.47.0022 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1220.47.0029 Boehringer Ingelheim Investigational Site
Austin, Texas
1220.47.0008 Boehringer Ingelheim Investigational Site
Bakersfield, California
1220.47.0064 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1220.47.0069 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1220.47.0085 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
1220.47.0087 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
1220.47.0004 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1220.47.0045 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1220.47.0057 Boehringer Ingelheim Investigational Site
Bradenton, Florida
1220.47.0083 Boehringer Ingelheim Investigational Site
Brooklyn, New York
1220.47.0015 Boehringer Ingelheim Investigational Site
Burlington, Vermont
1220.47.0053 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1220.47.0067 Boehringer Ingelheim Investigational Site
Chevy Chase, Maryland
1220.47.0013 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1220.47.0055 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1220.47.0019 Boehringer Ingelheim Investigational Site
Chula Vista, California
1220.47.0039 Boehringer Ingelheim Investigational Site
Columbus, Georgia
1220.47.0010 Boehringer Ingelheim Investigational Site
Coronado, California
1220.47.0017 Boehringer Ingelheim Investigational Site
Dallas, Texas
1220.47.0056 Boehringer Ingelheim Investigational Site
Dallas, Texas
1220.47.0071 Boehringer Ingelheim Investigational Site
Dallas, Texas
1220.47.0052 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1220.47.0050 Boehringer Ingelheim Investigational Site
Dothan, Alabama
1220.47.0082 Boehringer Ingelheim Investigational Site
Englewood, Colorado
1220.47.0043 Boehringer Ingelheim Investigational Site
Falls Church, Virginia
1220.47.0078 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1220.47.0086 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1220.47.0060 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
1220.47.0081 Boehringer Ingelheim Investigational Site
Forth Worth, Texas
1220.47.0027 Boehringer Ingelheim Investigational Site
Framingham, Massachusetts
1220.47.0030 Boehringer Ingelheim Investigational Site
Germantown, Tennessee
1220.47.0054 Boehringer Ingelheim Investigational Site
Hialeah, Florida
1220.47.0009 Boehringer Ingelheim Investigational Site
Houston, Texas
1220.47.0068 Boehringer Ingelheim Investigational Site
Houston, Texas
1220.47.0072 Boehringer Ingelheim Investigational Site
Jackson, Tennessee
1220.47.0033 Boehringer Ingelheim Investigational Site
La Jolla, California
1220.47.0035 Boehringer Ingelheim Investigational Site
La Mesa, California
1220.47.0046 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
1220.47.0011 Boehringer Ingelheim Investigational Site
Los Angeles, California
1220.47.0014 Boehringer Ingelheim Investigational Site
Los Angeles, California
1220.47.0100 Boehringer Ingelheim Investigational Site
Los Angeles, California
1220.47.0079 Boehringer Ingelheim Investigational Site
Lutherville, Maryland
1220.47.0088 Boehringer Ingelheim Investigational Site
Miami, Florida
1220.47.0073 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
1220.47.0032 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
1220.47.0041 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
1220.47.0066 Boehringer Ingelheim Investigational Site
Neptune City, New Jersey
1220.47.0049 Boehringer Ingelheim Investigational Site
New Haven, Connecticut
1220.47.0101 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
1220.47.0003 Boehringer Ingelheim Investigational Site
New York, New York
1220.47.0006 Boehringer Ingelheim Investigational Site
New York, New York
1220.47.0038 Boehringer Ingelheim Investigational Site
New York, New York
1220.47.0090 Boehringer Ingelheim Investigational Site
New York, New York
1220.47.0091 Boehringer Ingelheim Investigational Site
North Little Rock, Arkansas
1220.47.0018 Boehringer Ingelheim Investigational Site
Oceanside, California
1220.47.0044 Boehringer Ingelheim Investigational Site
Orlando, Florida
1220.47.0099 Boehringer Ingelheim Investigational Site
Orlando, Florida
1220.47.0095 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida
1220.47.0061 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1220.47.0028 Boehringer Ingelheim Investigational Site
Portland, Oregon
1220.47.0058 Boehringer Ingelheim Investigational Site
Portland, Oregon
1220.47.0059 Boehringer Ingelheim Investigational Site
Poway, California
1220.47.0026 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1220.47.0016 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1220.47.0024 Boehringer Ingelheim Investigational Site
San Diego, California
1220.47.0037 Boehringer Ingelheim Investigational Site
San Diego, California
1220.47.0031 Boehringer Ingelheim Investigational Site
San Francisco, California
1220.47.0092 Boehringer Ingelheim Investigational Site
Seattle, Washington
1220.47.0065 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts
1220.47.0074 Boehringer Ingelheim Investigational Site
Tampa, Florida
1220.47.0097 Boehringer Ingelheim Investigational Site
The Bronx, New York
1220.47.0023 Boehringer Ingelheim Investigational Site
Tulepo, Mississippi
1220.47.0098 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
1220.47.0062 Boehringer Ingelheim Investigational Site
Vaiparaiso, Indiana
1220.47.0021 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

Canada15 sites

1220.47.1011 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1220.47.1012 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1220.47.1013 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1220.47.1002 Boehringer Ingelheim Investigational Site
London, Ontario
1220.47.1010 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1220.47.1014 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1220.47.1004 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1220.47.1005 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1220.47.1006 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1220.47.1015 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1220.47.1001 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1220.47.1003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1220.47.1016 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1220.47.1007 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
1220.47.1009 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

South Korea7 sites

1220.47.8204 Boehringer Ingelheim Investigational Site
Pusan
1220.47.8205 Boehringer Ingelheim Investigational Site
Pusan
1220.47.8203 Boehringer Ingelheim Investigational Site
Seongnam
1220.47.8202 Boehringer Ingelheim Investigational Site
Seoul
1220.47.8206 Boehringer Ingelheim Investigational Site
Seoul
1220.47.8207 Boehringer Ingelheim Investigational Site
Seoul
1220.47.8201 Boehringer Ingelheim Investigational Site
Yangsan

Other trials in South Korea

Taiwan5 sites

1220.47.8803 Boehringer Ingelheim Investigational Site
Kaohsiung City
1220.47.8804 Boehringer Ingelheim Investigational Site
Kaohsiung City
1220.47.8802 Boehringer Ingelheim Investigational Site
Taichung
1220.47.8801 Boehringer Ingelheim Investigational Site
Taipei
1220.47.8805 Boehringer Ingelheim Investigational Site
Taipei

Other trials in Taiwan

Puerto Rico1 site

1220.47.0034 Boehringer Ingelheim Investigational Site
San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase III, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.

Conditions: Hepatitis C
Being tested: BI201335, PegIFN/RBV, 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.

BI201335Drug
QD BI 201335
PegIFN/RBVDrug
BI201335Drug
QD (once daily) BI 201335
PlaceboDrug

Study groups in NCT01297270
Study group	Role	What they receive
PegIFN/RBV	Active comparator	48 weeks Receives: Drug: PegIFN/RBV
BI 201335 for 24 weeks	Experimental	BI 201 335 QD dosing in combination with IFN/RBV Receives: Drug: PegIFN/RBV; Drug: BI201335
BI201335 for 12 weeks	Experimental	BI 201335 QD doing in combination with PEFG IFN/RBV Receives: Drug: BI201335; Drug: PegIFN/RBV
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

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

Secondary outcomes (10)

Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Hepatitis C virus Ribonucleic acid (HCV RNA)
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 (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.
Measured: Week 4 and week 8
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
Measured: 12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
Measured: 12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
Measured: 12 weeks post treatment, up to 60 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 12 weeks 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 at End of Treatment (EOT) When SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
Measured: 12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
Measured: 12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
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 12 weeks 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

Timeline

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

Apr 2011Apr 2014

First posted16 Feb 2011 (estimated)
Study startApr 2011
Primary completionApr 2014
Study completionApr 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 658 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01297270
Sponsor's protocol ID: 1220.47
Other IDs: 2010-021716-42
Status last verified: Aug 2015
First submitted: 15 Feb 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

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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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, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.
ClinicalTrials.gov ID: NCT01297270
Acronym / sponsor ID: 1220.47
Conditions: Hepatitis C
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 658 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 16 Feb 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: 4

Arm	Type	Receives
PegIFN/RBV	Active comparator	Drug: PegIFN/RBV48 weeks
BI 201335 for 24 weeks	Experimental	Drug: PegIFN/RBV, Drug: BI201335BI 201 335 QD dosing in combination with IFN/RBV
BI201335 for 12 weeks	Experimental	Drug: BI201335, Drug: PegIFN/RBVBI 201335 QD doing in combination with PEFG IFN/RBV
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (16 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 of the screening visit.

Key exclusion criteria (17 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.
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
BI201335QD BI 201335	Drug	BI201335 for 12 weeks
PegIFN/RBV	Drug	BI 201335 for 24 weeks, BI201335 for 12 weeks, PegIFN/RBV
BI201335QD (once daily) BI 201335	Drug	BI 201335 for 24 weeks
Placebo	Drug	Placebo

Primary outcome

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

10 secondary outcomes

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

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	262	217
Faldaprevir 240mg and PegIFN/RBV	264	192
Placebo and PegIFN/RBV	132	103

Primary outcome: Sustained Virologic 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 = 262	Faldaprevir 240mg and PegIFN/RBV n = 263	Placebo and PegIFN/RBV n = 132
Value	67.9 (62.3 to 73.6)	64.3 (58.5 to 70.1)	47.0 (38.5 to 55.5)

Faldaprevir 120mg and PegIFN/RBV vs Placebo and PegIFN/RBV: Mean Difference (Final Values): 20.7 (95% CI 10.7 to 30.6), p <0.0001, Cochran-Mantel-Haenszel
Faldaprevir 240mg and PegIFN/RBV vs Placebo and PegIFN/RBV: Mean Difference (Final Values): 17.4 (95% CI 7.3 to 27.4), p = 0.0007, Cochran-Mantel-Haenszel

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: Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Faldaprevir 120mg and PegIFN/RBV	21 of 262 (8%)	255 of 262 (97.3%)	Not reported
Faldaprevir 240mg and PegIFN/RBV	26 of 263 (9.9%)	258 of 263 (98.1%)	Not reported
Placebo and PegIFN/RBV	8 of 132 (6.1%)	130 of 132 (98.5%)	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.
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

106 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI201335 and PegIFN/RBV in people with Hepatitis C, run by Boehringer Ingelheim at 106 sites in 5 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 16 inclusion and 17 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 106 sites in United States, Canada, South Korea, Taiwan, Puerto Rico. 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. Some participants in this study may receive a placebo. 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 Virologic 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 NCT01297270, 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 18 Sep 2015.