Hepatitis C, ChronicPhase 3NCT01732796

IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

A Phase 3 study testing Ribavirin (RBV), BI 201335 (Faldaprevir) and BI 207127 in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 101 sites in 14 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 aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in 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 (RBV), BI 201335 (Faldaprevir) and BI 207127
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 470 participants
Where: 101 sitesin 14 countries
Study dates: Dec 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 HCV Ab or detectable HCV RNA at screening in addition to at least one of the following:
positive HCV RNA or HCV antibodies at least 6 months prior to screening, or
liver biopsy typical of chronic hepatitis C , or
history of elevated ALT at least 6 months prior to screening.
HCV infection of sub-GT1b confirmed by genotypic testing at screening
Treatment naïve defined as:

Show all 22Show fewer

no prior treatment with any interferon, pegylated interferon, and /or ribavirin and
no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection
Plasma HCV RNA > or = 1,000 IU/mL at screening
Liver biopsy within three years or fibroscan within six months prior to randomization. Patients with compensated liver cirrhosis (score Child-Pugh A) could also be included.
Age 18 to 75 years
Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to randomization
with documented hysterectomy, or
who have had both ovaries removed, or
with documented tubal ligation, or
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 a negative urine pregnancy test on Day 1 (Visit 2), that agree to use two non-hormonal methods of birth control from the date of screening until months after the last dose of ribavirin. They must not 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 diaphragm with spermicide substance, intrauterine devices, cervical caps and condoms.
OR:
Male patients
who are documented to be sterile, or
who consistently and correctly use a condom while their female partners (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin, and
without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and follow-up phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).

Who cannot join

HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
HCV subtype 1a, mixed 1a/1b or GT1 undefined
Evidence of liver disease mainly due to causes other than chronic HCV infection such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease
HIV-1 or HIV-2 infection
Hepatitis B virus (HBV) infection based on presence of HBs-Ag
Evidence of decompensated liver disease, or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, or bleeding esophageal varices,

Show all 11Show fewer

International Normalized Ratio (INR) > or =1.7
Serum albumin < 3.3 g/dL
Serum total bilirubin >2.0 times the upper limit of normal (ULN) with direct/indirect ratio >1, unless history of Gilbert's disease
Active or suspected malignancy or history of malignancy within the last 5 years (with the exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
Patients with ongoing or historical photosensitivity or recurrent rash

Trial locations and contacts

101 sites in 14 countries.

Country

City, postcode or hospital

101 sites in 14 countries

United States24 sites

1241.20.00005 Boehringer Ingelheim Investigational Site
Austin, Texas
1241.20.00018 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1241.20.00002 Boehringer Ingelheim Investigational Site
Chevy Chase, Maryland
1241.20.00033 Boehringer Ingelheim Investigational Site
Chula Vista, California
1241.20.00017 Boehringer Ingelheim Investigational Site
Dallas, Texas
1241.20.00010 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1241.20.00026 Boehringer Ingelheim Investigational Site
Dothan, Alabama
1241.20.00015 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1241.20.00014 Boehringer Ingelheim Investigational Site
Ft. Pierce, Florida
1241.20.00012 Boehringer Ingelheim Investigational Site
Houston, Texas
1241.20.00022 Boehringer Ingelheim Investigational Site
Houston, Texas
1241.20.00006 Boehringer Ingelheim Investigational Site
La Mesa, California
1241.20.00009 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
1241.20.00004 Boehringer Ingelheim Investigational Site
Maitland, Florida
1241.20.00001 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
1241.20.00016 Boehringer Ingelheim Investigational Site
New York, New York
1241.20.00031 Boehringer Ingelheim Investigational Site
New York, New York
1241.20.00003 Boehringer Ingelheim Investigational Site
Oceanside, California
1241.20.00013 Boehringer Ingelheim Investigational Site
Portland, Oregon
1241.20.00008 Boehringer Ingelheim Investigational Site
Poway, California
1241.20.00020 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1241.20.00019 Boehringer Ingelheim Investigational Site
Rochester, New York
1241.20.00032 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts
1241.20.00024 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma

Other trials in United States

Germany14 sites

1241.20.49002 Boehringer Ingelheim Investigational Site
Berlin
1241.20.49004 Boehringer Ingelheim Investigational Site
Berlin
1241.20.49012 Boehringer Ingelheim Investigational Site
Bonn
1241.20.49013 Boehringer Ingelheim Investigational Site
Cologne
1241.20.49001 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1241.20.49014 Boehringer Ingelheim Investigational Site
Hamburg
1241.20.49009 Boehringer Ingelheim Investigational Site
Herne
1241.20.49008 Boehringer Ingelheim Investigational Site
Kiel
1241.20.49011 Boehringer Ingelheim Investigational Site
Leipzig
1241.20.49006 Boehringer Ingelheim Investigational Site
Magdeburg
1241.20.49003 Boehringer Ingelheim Investigational Site
München
1241.20.49010 Boehringer Ingelheim Investigational Site
Oberhausen
1241.20.49005 Boehringer Ingelheim Investigational Site
Ulm
1241.20.49007 Boehringer Ingelheim Investigational Site
Würzburg

Other trials in Germany

France9 sites

1241.20.33003 Boehringer Ingelheim Investigational Site
Clermont-Ferrand
1241.20.33004 Boehringer Ingelheim Investigational Site
Lyon
1241.20.33006 Boehringer Ingelheim Investigational Site
Marseille
1241.20.33001 Boehringer Ingelheim Investigational Site
Montpellier
1241.20.33005 Boehringer Ingelheim Investigational Site
Nice
1241.20.33007 Boehringer Ingelheim Investigational Site
Paris
1241.20.33002 Boehringer Ingelheim Investigational Site
Pessac
1241.20.33009 Boehringer Ingelheim Investigational Site
Rennes
1241.20.33008 Boehringer Ingelheim Investigational Site
Vandœuvre-lès-Nancy

Other trials in France

Canada8 sites

1241.20.01006 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1241.20.01007 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1241.20.01002 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1241.20.01001 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1241.20.01008 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1241.20.01010 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1241.20.01003 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
1241.20.01005 Boehringer Ingelheim Investigational Site
Whitby, Ontario

Other trials in Canada

Italy8 sites

1241.20.39007 Boehringer Ingelheim Investigational Site
Ancona
1241.20.39003 Boehringer Ingelheim Investigational Site
Brescia
1241.20.39002 Boehringer Ingelheim Investigational Site
Milan
1241.20.39008 Boehringer Ingelheim Investigational Site
Milan
1241.20.39006 Boehringer Ingelheim Investigational Site
Naples
1241.20.39005 Boehringer Ingelheim Investigational Site
Pavia
1241.20.39001 Boehringer Ingelheim Investigational Site
Torino
1241.20.39004 Boehringer Ingelheim Investigational Site
Torino

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Spain8 sites

1241.20.34007 Boehringer Ingelheim Investigational Site
A Coruña
1241.20.34004 Boehringer Ingelheim Investigational Site
Alicante
1241.20.34002 Boehringer Ingelheim Investigational Site
Barcelona
1241.20.34005 Boehringer Ingelheim Investigational Site
Barcelona
1241.20.34003 Boehringer Ingelheim Investigational Site
Madrid
1241.20.34001 Boehringer Ingelheim Investigational Site
Majadahonda, Madrid
1241.20.34008 Boehringer Ingelheim Investigational Site
Santander
1241.20.34006 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

United Kingdom7 sites

1241.20.44005 Boehringer Ingelheim Investigational Site
Bristol
1241.20.44007 Boehringer Ingelheim Investigational Site
Liverpool
1241.20.44001 Boehringer Ingelheim Investigational Site
London
1241.20.44002 Boehringer Ingelheim Investigational Site
London
1241.20.44006 Boehringer Ingelheim Investigational Site
London
1241.20.44004 Boehringer Ingelheim Investigational Site
Nottingham
1241.20.44003 Boehringer Ingelheim Investigational Site
Southampton

Other trials in United Kingdom

Netherlands5 sites

1241.20.31001 Boehringer Ingelheim Investigational Site
Amsterdam
1241.20.31003 Boehringer Ingelheim Investigational Site
Amsterdam
1241.20.31004 Boehringer Ingelheim Investigational Site
Amsterdam
1241.20.31005 Boehringer Ingelheim Investigational Site
Groningen
1241.20.31006 Boehringer Ingelheim Investigational Site
The Hague

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Portugal5 sites

1241.20.35103 Boehringer Ingelheim Investigational Site
Aveiro
1241.20.35104 Boehringer Ingelheim Investigational Site
Coimbra
1241.20.35101 Boehringer Ingelheim Investigational Site
Lisbon
1241.20.35102 Boehringer Ingelheim Investigational Site
Porto
1241.20.35105 Boehringer Ingelheim Investigational Site
Vila Real

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Russia4 sites

1241.20.70002 Boehringer Ingelheim Investigational Site
Chelyabinsk
1241.20.70001 Boehringer Ingelheim Investigational Site
Moscow
1241.20.70004 Boehringer Ingelheim Investigational Site
Saint Petersburg
1241.20.70005 Boehringer Ingelheim Investigational Site
Saint Petersburg

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Ireland3 sites

1241.20.35301 Boehringer Ingelheim Investigational Site
Dublin
1241.20.35302 Boehringer Ingelheim Investigational Site
Dublin
1241.20.35303 Boehringer Ingelheim Investigational Site
Dublin

Other trials in Ireland

Romania3 sites

1241.20.40001 Boehringer Ingelheim Investigational Site
Bucharest
1241.20.40002 Boehringer Ingelheim Investigational Site
Bucharest
1241.20.40003 Boehringer Ingelheim Investigational Site
Bucharest

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Hungary2 sites

1241.20.36001 Boehringer Ingelheim Investigational Site
Budapest
1241.20.36002 Boehringer Ingelheim Investigational Site
Kaposvár

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Austria1 site

1241.20.43003 Boehringer Ingelheim Investigational Site
Graz

Other trials in Austria

About this study

Official title: A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Conditions: Hepatitis C, Chronic
Being tested: Ribavirin (RBV), BI 201335 (Faldaprevir), BI 207127, Faldaprevir (BI 201335)
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.

Ribavirin (RBV)Drug
24 weeks of active RBV
BI 201335 (Faldaprevir)Drug
16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335
Ribavirin (RBV)Drug
24 weeks of active RBV
BI 207127Drug
24 weeks of BI 207127
BI 201335 (Faldaprevir)Drug
24 weeks of BI 201335
Ribavirin (RBV)Drug
16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin
BI 207127Drug
16 weeks BI 207127 followed by 8 weeks placebo to BI 207127
Faldaprevir (BI 201335)Drug
24 weeks of 201335
BI 207127Drug
24 weeks of BI 207127

Study groups in NCT01732796
Study group	Role	What they receive
Allocated 24 weeks BI 207127 + BI 201335	Experimental	24 weeks of BI 207127 and BI 201335 in combination with Ribavirin Receives: Drug: Ribavirin (RBV); Drug: BI 201335 (Faldaprevir); Drug: BI 207127
Randomized 16 weeks BI 7127+BI1335 + RBV	Experimental	16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV Receives: Drug: BI 201335 (Faldaprevir); Drug: Ribavirin (RBV); Drug: BI 207127
Randomized 24weeks BI 7127+ BI1335 + RBV	Experimental	24 weeks of BI 207127and BI 201335 in combination with RBV Receives: Drug: Ribavirin (RBV); Drug: BI 207127; Drug: Faldaprevir (BI 201335)

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 ribonucleic acid (HCV RNA) level <25 international units/millilitre (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
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 (2)

SVR4
Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).
Measured: 4 Week (post-treatment)
SVR24
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).
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.

Dec 2012Jan 2015

First posted26 Nov 2012 (estimated)
Study startDec 2012
Primary completionJan 2015
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: 470 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01732796
Sponsor's protocol ID: 1241.20
Other IDs: 2012-003533-41
Status last verified: Mar 2016
First submitted: 6 Nov 2012
Last updated: 18 Apr 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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Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
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All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection
ClinicalTrials.gov ID: NCT01732796
Acronym / sponsor ID: 1241.20
Conditions: Hepatitis C, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 470 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 26 Nov 2012 (estimated)
Results: Posted 18 Apr 2016

Clinical summary

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

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
Allocated 24 weeks BI 207127 + BI 201335	Experimental	Drug: Ribavirin (RBV), Drug: BI 201335 (Faldaprevir), Drug: BI 20712724 weeks of BI 207127 and BI 201335 in combination with Ribavirin
Randomized 16 weeks BI 7127+BI1335 + RBV	Experimental	Drug: BI 201335 (Faldaprevir), Drug: Ribavirin (RBV), Drug: BI 20712716 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
Randomized 24weeks BI 7127+ BI1335 + RBV	Experimental	Drug: Ribavirin (RBV), Drug: BI 207127, Drug: Faldaprevir (BI 201335)24 weeks of BI 207127and BI 201335 in combination with RBV

Who may qualify

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

Key inclusion criteria (22 listed)

Chronic hepatitis C infection, diagnosed by positive HCV Ab or detectable HCV RNA at screening in addition to at least one of the following:
HCV infection of sub-GT1b confirmed by genotypic testing at screening
Treatment naïve defined as:
Plasma HCV RNA > or = 1,000 IU/mL at screening
Liver biopsy within three years or fibroscan within six months prior to randomization. Patients with compensated liver cirrhosis (score Child-Pugh A) could also be included.

Key exclusion criteria (11 listed)

HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
HCV subtype 1a, mixed 1a/1b or GT1 undefined
Evidence of liver disease mainly due to causes other than chronic HCV infection such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease
HIV-1 or HIV-2 infection
Hepatitis B virus (HBV) 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
Ribavirin (RBV)24 weeks of active RBV	Drug	Allocated 24 weeks BI 207127 + BI 201335
BI 201335 (Faldaprevir)16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335	Drug	Randomized 16 weeks BI 7127+BI1335 + RBV
Ribavirin (RBV)24 weeks of active RBV	Drug	Randomized 24weeks BI 7127+ BI1335 + RBV
BI 20712724 weeks of BI 207127	Drug	Randomized 24weeks BI 7127+ BI1335 + RBV
BI 201335 (Faldaprevir)24 weeks of BI 201335	Drug	Allocated 24 weeks BI 207127 + BI 201335
Ribavirin (RBV)16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin	Drug	Randomized 16 weeks BI 7127+BI1335 + RBV
BI 20712716 weeks BI 207127 followed by 8 weeks placebo to BI 207127	Drug	Randomized 16 weeks BI 7127+BI1335 + RBV
Faldaprevir (BI 201335)24 weeks of 201335	Drug	Randomized 24weeks BI 7127+ BI1335 + RBV
BI 20712724 weeks of BI 207127	Drug	Allocated 24 weeks BI 207127 + BI 201335

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 ribonucleic acid (HCV RNA) level <25 international units/millilitre (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
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.

2 secondary outcomes

SVR4
Time frame: 4 Week (post-treatment)
SVR24
Time frame: 24 Week (post-treatment)

Results and safety

Results posted to the registry on 18 Apr 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
16 wk NC FDV+DBV+RBV	208	162
24 wk NC FDV+DBV+RBV	211	169
24 wk CR FDV+DBV+RBV	51	38

Primary outcome: SVR12 Rates With Historical Control

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

Measure	24 wk FDV+DBV+RBV n = 262	16 wk FDV+DBV+RBV n = 259
non-cirrhotic (N=174, 149)	82.5	71.6
cirrhotic (N=37, 37)	72.5	72.5

24 wk FDV+DBV+RBV: Adjusted response rate: 81.4 (95% CI 76.6 to 86.2), p <0.0001, Stratified one sample z-test
16 wk FDV+DBV+RBV: Adjusted response rate: 71.7 (95% CI 66.1 to 77.4), p = 0.3989, Stratified one sample z-test

Population analysed: The primary analyses of efficacy were carried out on an intent-to-treat basis including all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication (FAS).

Primary outcome: Comparisons of SVR12 Rates Across Treatment Arms

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

Measure	16 wk NC FDV+DBV+RBV n = 208	24 wk NC FDV+DBV+RBV n = 211	24 wk CR FDV+DBV+RBV n = 51
Value	71.6	82.5	72.5

16 wk NC FDV+DBV+RBV vs 24 wk NC FDV+DBV+RBV: Koch's method with continuity correction: 10.8 (95% CI 2.8 to 18.8), p = 0.0040, z-test

Population analysed: FAS

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
16 wk NC FDV+DBV+RBV	7 of 208 (3.4%)	192 of 208 (92.3%)	Not reported
24 wk NC FDV+DBV+RBV	11 of 211 (5.2%)	198 of 211 (93.8%)	Not reported
24 wk CR FDV+DBV+RBV	4 of 51 (7.8%)	49 of 51 (96.1%)	Not reported

Limitations and caveats (from the sponsor): BI stopped the further development of DBV, per protocol amendment the Follow-up period was reduced to 24 weeks for patients who achieved SVR12, and to 48 weeks for SVR12 non-responders provided they had not started an alternative HCV treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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 linksLink 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

101 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ribavirin (RBV), BI 201335 (Faldaprevir) and BI 207127 in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 101 sites in 14 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 22 inclusion and 11 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, Germany, France, Canada, Italy and 9 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 Apr 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 NCT01732796, 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 Apr 2016.