Hepatitis C, ChronicPhase 3NCT01728324

Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2

A Phase 3 study testing Ribavirin: 24-week treatment, BI 207127: 24-week treatment and Faldaprevir: 24-week treatment in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 109 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 the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Ribavirin: 24-week treatment, BI 207127: 24-week treatment and Faldaprevir: 24-week treatment
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 496 participants
Where: 109 sitesin 12 countries
Study dates: Nov 2012to Jan 2015
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 75 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
HCV infection of sub-GT1b confirmed by genotypic testing at screening.
HCV viral load =1,000 IU/mL at randomisation.
Patients who have never been previously treated with any other HCV treatment regimen.

Who cannot join

HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1.
Liver disease due to causes other than chronic HCV infection.
HIV infection.
Hepatitis B virus infection based on presence of HBs-Ag.
Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening.

Show all 12Show fewer

History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).
Decompensated liver disease, or history of decompensated liver disease.
Clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia.
Red blood cell disorders.
Body weight <40 kg or >125 kg.

Trial locations and contacts

109 sites in 12 countries.

Country

City, postcode or hospital

109 sites in 12 countries

United States31 sites

1241.36.00020 Boehringer Ingelheim Investigational Site
Anaheim, California
1241.36.00002 Boehringer Ingelheim Investigational Site
Arlington, Texas
1241.36.00027 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1241.36.00039 Boehringer Ingelheim Investigational Site
Austin, Texas
1241.36.00005 Boehringer Ingelheim Investigational Site
Bakersfield, California
1241.36.00017 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
1241.36.00022 Boehringer Ingelheim Investigational Site
Bradenton, Florida
1241.36.00026 Boehringer Ingelheim Investigational Site
Charlottesville, Virginia
1241.36.00033 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1241.36.00031 Boehringer Ingelheim Investigational Site
Dallas, Texas
1241.36.00004 Boehringer Ingelheim Investigational Site
DeLand, Florida
1241.36.00006 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1241.36.00003 Boehringer Ingelheim Investigational Site
Gainesville, Florida
1241.36.00032 Boehringer Ingelheim Investigational Site
Hillsborough, New Jersey
1241.36.00043 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
1241.36.00009 Boehringer Ingelheim Investigational Site
La Jolla, California
1241.36.00007 Boehringer Ingelheim Investigational Site
Los Angeles, California
1241.36.00008 Boehringer Ingelheim Investigational Site
Murray, Utah
1241.36.00044 Boehringer Ingelheim Investigational Site
Newport News, Virginia
1241.36.00015 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
1241.36.00016 Boehringer Ingelheim Investigational Site
North Little Rock, Arkansas
1241.36.00013 Boehringer Ingelheim Investigational Site
Oceanside, California
1241.36.00010 Boehringer Ingelheim Investigational Site
Orlando, Florida
1241.36.00024 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida
1241.36.00029 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1241.36.00019 Boehringer Ingelheim Investigational Site
San Diego, California
1241.36.00034 Boehringer Ingelheim Investigational Site
San Francisco, California
1241.36.00035 Boehringer Ingelheim Investigational Site
Springfield, Illinois
1241.36.00018 Boehringer Ingelheim Investigational Site
Tupelo, Mississippi
1241.36.00001 Boehringer Ingelheim Investigational Site
Valparaiso, Indiana
1241.36.00030 Boehringer Ingelheim Investigational Site
Zephyrhills, Florida

Other trials in United States

United Kingdom11 sites

1241.36.44003 Boehringer Ingelheim Investigational Site
Birmingham
1241.36.44006 Boehringer Ingelheim Investigational Site
Edinburgh
1241.36.44011 Boehringer Ingelheim Investigational Site
Hull
1241.36.44013 Boehringer Ingelheim Investigational Site
Leeds
1241.36.44008 Boehringer Ingelheim Investigational Site
Leicester
1241.36.44001 Boehringer Ingelheim Investigational Site
London
1241.36.44005 Boehringer Ingelheim Investigational Site
London
1241.36.44007 Boehringer Ingelheim Investigational Site
Manchester
1241.36.44010 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne
1241.36.44002 Boehringer Ingelheim Investigational Site
Oxford
1241.36.44004 Boehringer Ingelheim Investigational Site
Plymouth

Other trials in United Kingdom

Germany10 sites

1241.36.49011 Boehringer Ingelheim Investigational Site
Aachen
1241.36.49001 Boehringer Ingelheim Investigational Site
Berlin
1241.36.49012 Boehringer Ingelheim Investigational Site
Dortmund
1241.36.49004 Boehringer Ingelheim Investigational Site
Düsseldorf
1241.36.49008 Boehringer Ingelheim Investigational Site
Erlangen
1241.36.49009 Boehringer Ingelheim Investigational Site
Esslingen am Neckar
1241.36.49014 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1241.36.49002 Boehringer Ingelheim Investigational Site
Hamburg
1241.36.49007 Boehringer Ingelheim Investigational Site
Mainz
1241.36.49013 Boehringer Ingelheim Investigational Site
Tübingen

Other trials in Germany

Australia9 sites

1241.36.61005 Boehringer Ingelheim Investigational Site
Camperdown, New South Wales
1241.36.61004 Boehringer Ingelheim Investigational Site
Clayton, Victoria
1241.36.61001 Boehringer Ingelheim Investigational Site
Darlinghurst, Victoria
1241.36.61008 Boehringer Ingelheim Investigational Site
Heidelberg, Victoria
1241.36.61002 Boehringer Ingelheim Investigational Site
Herston, Queensland
1241.36.61010 Boehringer Ingelheim Investigational Site
Kogarah, New South Wales
1241.36.61006 Boehringer Ingelheim Investigational Site
Melbourne, Victoria
1241.36.61009 Boehringer Ingelheim Investigational Site
New Lambton, New South Wales
1241.36.61007 Boehringer Ingelheim Investigational Site
Randwick, New South Wales

Other trials in Australia

Italy9 sites

1241.36.39025 Boehringer Ingelheim Investigational Site
Antella (fi)
1241.36.39023 Boehringer Ingelheim Investigational Site
Bisceglie (bat)
1241.36.39021 Boehringer Ingelheim Investigational Site
Bologna
1241.36.39022 Boehringer Ingelheim Investigational Site
Milan
1241.36.39020 Boehringer Ingelheim Investigational Site
Palermo
1241.36.39026 Boehringer Ingelheim Investigational Site
Pavia
1241.36.39028 Boehringer Ingelheim Investigational Site
Pescara
1241.36.39029 Boehringer Ingelheim Investigational Site
Roma
1241.36.39024 Boehringer Ingelheim Investigational Site
San Giovanni Rotondo (fg)

Other trials in Italy

France8 sites

1241.36.33001 Boehringer Ingelheim Investigational Site
Clichy
1241.36.33004 Boehringer Ingelheim Investigational Site
Créteil
1241.36.33002 Boehringer Ingelheim Investigational Site
Grenoble
1241.36.33003 Boehringer Ingelheim Investigational Site
Paris
1241.36.33008 Boehringer Ingelheim Investigational Site
Paris
1241.36.33006 Boehringer Ingelheim Investigational Site
Saint-Laurent-du-Var
1241.36.33005 Boehringer Ingelheim Investigational Site
Toulouse
1241.36.33007 Boehringer Ingelheim Investigational Site
Villejuif

Other trials in France

Spain8 sites

1241.36.34006 Boehringer Ingelheim Investigational Site
Badalona (Barcelona)
1241.36.34002 Boehringer Ingelheim Investigational Site
Barcelona
1241.36.34004 Boehringer Ingelheim Investigational Site
Barcelona
1241.36.34001 Boehringer Ingelheim Investigational Site
L'Hospitalet Llobregat (bcn)
1241.36.34005 Boehringer Ingelheim Investigational Site
Madrid
1241.36.34008 Boehringer Ingelheim Investigational Site
Málaga
1241.36.34003 Boehringer Ingelheim Investigational Site
Seville
1241.36.34007 Boehringer Ingelheim Investigational Site
Vigo (Pontevedra)

Other trials in Spain

Belgium7 sites

1241.36.32006 Boehringer Ingelheim Investigational Site
Antwerp
1241.36.32001 Boehringer Ingelheim Investigational Site
Brussels
1241.36.32004 Boehringer Ingelheim Investigational Site
Edegem
1241.36.32005 Boehringer Ingelheim Investigational Site
Ghent
1241.36.32002 Boehringer Ingelheim Investigational Site
Leuven
1241.36.32003 Boehringer Ingelheim Investigational Site
Liège
1241.36.32007 Boehringer Ingelheim Investigational Site
Roeselare

Other trials in Belgium

Canada7 sites

1241.36.01005 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1241.36.01003 Boehringer Ingelheim Investigational Site
London, Ontario
1241.36.01001 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1241.36.01004 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1241.36.01007 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1241.36.01006 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1241.36.01002 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

Greece4 sites

1241.36.30001 Boehringer Ingelheim Investigational Site
Athens
1241.36.30002 Boehringer Ingelheim Investigational Site
Athens
1241.36.30003 Boehringer Ingelheim Investigational Site
Pátrai
1241.36.30004 Boehringer Ingelheim Investigational Site
Rhodes

Other trials in Greece

Portugal3 sites

1241.36.35103 Boehringer Ingelheim Investigational Site
Barreiro
1241.36.35104 Boehringer Ingelheim Investigational Site
Coimbra
1241.36.35101 Boehringer Ingelheim Investigational Site
Lisbon

Other trials in Portugal

New Zealand2 sites

1241.36.64001 Boehringer Ingelheim Investigational Site
Auckland NZ
1241.36.64002 Boehringer Ingelheim Investigational Site
Hamilton

Other trials in New Zealand

About this study

Official title: A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon

Conditions: Hepatitis C, Chronic
Being tested: BI 207127-placebo: 8-week treatment, Ribavirin: 24-week treatment, BI 207127: 24-week treatment, Faldaprevir: 24-week treatment, Ribavirin-placebo: 8-week treatment
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 207127-placebo: 8-week treatmentDrug
8 weeks of placebo treatment
Ribavirin: 24-week treatmentDrug
24 weeks of active treatment
BI 207127: 24-week treatmentDrug
24 weeks of active treatment
Faldaprevir: 24-week treatmentDrug
24 weeks of active treatment
Faldaprevir: 24-week treatmentDrug
24 weeks of active treatment
Ribavirin-placebo: 8-week treatmentDrug
8 weeks of placebo treatment
BI 207127: 24-week treatmentDrug
24 weeks of active treatment
Faldaprevir-placebo: 8-week treatmentDrug
8 weeks of placebo treatment
Faldaprevir: 16-week treatmentDrug
16 weeks of active treatment
Ribavirin: 16-week treatmentDrug
16 weeks of active treatment
RBV: 24-week treatmentDrug
24 weeks of active treatment
BI 207127: 16-week treatmentDrug
16 weeks of active treatment

Study groups in NCT01728324
Study group	Role	What they receive
Randomised 24-week arm	Experimental	BI 207127 in combination with FDV and RBV for 24 weeks (randomised) Receives: Drug: BI 207127: 24-week treatment; Drug: Faldaprevir: 24-week treatment; Drug: RBV: 24-week treatment
Randomised 16-week arm	Experimental	BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised) Receives: Drug: BI 207127-placebo: 8-week treatment; Drug: Ribavirin-placebo: 8-week treatment; Drug: Faldaprevir-placebo: 8-week treatment; Drug: Faldaprevir: 16-week treatment; Drug: Ribavirin: 16-week treatment; Drug: BI 207127: 16-week treatment
Allocated 24-week arm	Experimental	BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis) Receives: Drug: Ribavirin: 24-week treatment; Drug: Faldaprevir: 24-week treatment; Drug: BI 207127: 24-week treatment

What is being measured

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

SVR12 Rates With Historical Control
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.
The number of participants analyzed are actually adjusted number of participant analyzed.
Measured: 12 Week (post-treatment)
Comparisons of SVR12 Rates Across Treatment Arms
Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
Measured: 12 Week (post-treatment)

Secondary outcomes (3)

SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT.
Measured: 4 weeks (after End Of Treatment)
SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.
Measured: 4 weeks (after End Of Treatment)
Prognostic Value of SVR12 Predicting SVR24
The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.
Measured: 24 Week (post-treatment)

Timeline

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

Nov 2012Jan 2015

First posted19 Nov 2012 (estimated)
Study startNov 2012
Primary completionFeb 2014
Study completionJan 2015

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 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
Enrolment: 496 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01728324
Sponsor's protocol ID: 1241.36
Other IDs: 2012-003535-27
Status last verified: Jan 2016
First submitted: 2 Nov 2012
Last updated: 12 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016.
PubMed 27920566

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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All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon
ClinicalTrials.gov ID: NCT01728324
Acronym / sponsor ID: 1241.36
Conditions: Hepatitis C, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 496 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Feb 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 19 Nov 2012 (estimated)
Results: Posted 12 Feb 2016

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
Randomised 24-week arm	Experimental	Drug: BI 207127: 24-week treatment, Drug: Faldaprevir: 24-week treatment, Drug: RBV: 24-week treatmentBI 207127 in combination with FDV and RBV for 24 weeks (randomised)
Randomised 16-week arm	Experimental	Drug: BI 207127-placebo: 8-week treatment, Drug: Ribavirin-placebo: 8-week treatment, Drug: Faldaprevir-placebo: 8-week treatment, Drug: Faldaprevir: 16-week treatment, Drug: Ribavirin: 16-week treatment, Drug: BI 207127: 16-week treatmentBI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
Allocated 24-week arm	Experimental	Drug: Ribavirin: 24-week treatment, Drug: Faldaprevir: 24-week treatment, Drug: BI 207127: 24-week treatmentBI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening
HCV infection of sub-GT1b confirmed by genotypic testing at screening.
HCV viral load =1,000 IU/mL at randomisation.
Patients who have never been previously treated with any other HCV treatment regimen.

Key exclusion criteria (12 listed)

HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1.
Liver disease due to causes other than chronic HCV infection.
HIV infection.
Hepatitis B virus infection based on presence of HBs-Ag.

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 207127-placebo: 8-week treatment8 weeks of placebo treatment	Drug	Randomised 16-week arm
Ribavirin: 24-week treatment24 weeks of active treatment	Drug	Allocated 24-week arm
BI 207127: 24-week treatment24 weeks of active treatment	Drug	Randomised 24-week arm
Faldaprevir: 24-week treatment24 weeks of active treatment	Drug	Allocated 24-week arm
Faldaprevir: 24-week treatment24 weeks of active treatment	Drug	Randomised 24-week arm
Ribavirin-placebo: 8-week treatment8 weeks of placebo treatment	Drug	Randomised 16-week arm
BI 207127: 24-week treatment24 weeks of active treatment	Drug	Allocated 24-week arm
Faldaprevir-placebo: 8-week treatment8 weeks of placebo treatment	Drug	Randomised 16-week arm
Faldaprevir: 16-week treatment16 weeks of active treatment	Drug	Randomised 16-week arm
Ribavirin: 16-week treatment16 weeks of active treatment	Drug	Randomised 16-week arm
RBV: 24-week treatment24 weeks of active treatment	Drug	Randomised 24-week arm
BI 207127: 16-week treatment16 weeks of active treatment	Drug	Randomised 16-week arm

Primary outcome

SVR12 Rates With Historical Control
Time frame: 12 Week (post-treatment)
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint. The number of participants analyzed are actually adjusted number of participant analyzed.
Comparisons of SVR12 Rates Across Treatment Arms
Time frame: 12 Week (post-treatment)
Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.

3 secondary outcomes

SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
Time frame: 4 weeks (after End Of Treatment)
SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
Time frame: 4 weeks (after End Of Treatment)
Prognostic Value of SVR12 Predicting SVR24
Time frame: 24 Week (post-treatment)

Results and safety

Results posted to the registry on 12 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
24-wk Non-cirrhotic (NC) Treatment Group	211	173
16-wk Non-cirrhotic (NC) Treatment Group	213	177
24-wk Cirrhotic (CR) Treatment Group	72	58

Primary outcome: SVR12 Rates With Historical Control

Time frame: 12 Week (post-treatment). Number. Unit: percentage of participants

Measure	24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group n = 283	16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group n = 283
PegIFN eligible	79.95	76.68
PegIFN ineligible	88.28	70.78

24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group: Adjusted response rate: 81.10 (95% CI 76.34 to 85.87), p <0.0001, z-test
16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group: Adjusted response rate: 75.89 (95% CI 70.63 to 81.14), p = 0.0020, z-test

Population analysed: Modified full analysis set (mFAS): included patients in the full analysis set (FAS) who received at least one dose of active treatment;

Primary outcome: Comparisons of SVR12 Rates Across Treatment Arms

Time frame: 12 Week (post-treatment). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	24-wk Non-cirrhotic (NC) Treatment Group n = 211	16-wk Non-cirrhotic (NC) Treatment Group n = 213	24-wk Cirrhotic (CR) Treatment Group n = 72
Value	82.0 (76.8 to 87.2)	75.6 (69.8 to 81.4)	73.6 (63.4 to 83.8)

24-wk Non-cirrhotic (NC) Treatment Group vs 16-wk Non-cirrhotic (NC) Treatment Group: SVR12 Rates difference: 6.4 (95% CI -1.4 to 14.2), p = 0.0532, Koch's method

Population analysed: FAS

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 28 days after all treatment discontinuation, upto 226 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
24-wk Non-cirrhotic (NC) Treatment Group	7 of 211 (3.3%)	198 of 211 (93.8%)	Not reported
16-wk Non-cirrhotic (NC) Treatment Group	12 of 213 (5.6%)	202 of 213 (94.8%)	Not reported
24-wk Cirrhotic (CR) Treatment Group	8 of 72 (11.1%)	66 of 72 (91.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27920566Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016.

Related trials for Hepatitis C, Chronic

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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

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

Questions about this trial

What is this clinical trial studying?

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

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States, United Kingdom, Germany, Australia, Italy 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 12 Feb 2016). 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?

SVR12 Rates With Historical Control (time frame: 12 Week (post-treatment)). The study lists 2 primary outcomes in all. 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 NCT01728324, 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 12 Feb 2016.