Hepatitis C, ChronicPhase 2NCT01830127

BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3

A Phase 2 study testing Ribavirin, BI 207127 high dose and Faldaprevir in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 19 sites in 4 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

To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with… 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, BI 207127 high dose and Faldaprevir
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 19 sitesin 4 countries
Study dates: Apr 2013to Oct 2014
Phase: Phase 2
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

Treatment naïve and treatment experienced patients (prior relapse, interferon intolerant, and [allowed in Cohort A only] prior partial response).
Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only.
Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver stiffness of =13 kPa on fibroscan.

Who cannot join

HCV infection of mixed genotype (1/2, 1/3, and 1/4) or mixed sub-GT1a/1b or undefined diagnosed by genotypic testing at screening
Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases.
HIV infection
Patients who have been previously treated with an investigational or approved DAA

Trial locations and contacts

19 sites in 4 countries.

Country

City, postcode or hospital

19 sites in 4 countries

Germany8 sites

1241.30.49002 Boehringer Ingelheim Investigational Site
Berlin
1241.30.49004 Boehringer Ingelheim Investigational Site
Berlin
1241.30.49005 Boehringer Ingelheim Investigational Site
Berlin
1241.30.49008 Boehringer Ingelheim Investigational Site
Bonn
1241.30.49006 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1241.30.49001 Boehringer Ingelheim Investigational Site
Hanover
1241.30.49003 Boehringer Ingelheim Investigational Site
Leipzig
1241.30.49007 Boehringer Ingelheim Investigational Site
Mainz

Other trials in Germany

United States6 sites

1241.30.10011 Boehringer Ingelheim Investigational Site
Arlington, Texas
1241.30.10001 Boehringer Ingelheim Investigational Site
DeLand, Florida
1241.30.10003 Boehringer Ingelheim Investigational Site
La Mesa, California
1241.30.10002 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
1241.30.10007 Boehringer Ingelheim Investigational Site
San Diego, California
1241.30.10012 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida

Other trials in United States

Spain4 sites

1241.30.34002 Boehringer Ingelheim Investigational Site
Barcelona
1241.30.34005 Boehringer Ingelheim Investigational Site
Barcelona
1241.30.34003 Boehringer Ingelheim Investigational Site
Madrid
1241.30.34001 Boehringer Ingelheim Investigational Site
Majadahonda (Madrid)

Other trials in Spain

United Kingdom1 site

1241.30.44002 Boehringer Ingelheim Investigational Site
London

Other trials in United Kingdom

About this study

Official title: A Phase IIb Open Label Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Patients With Moderate Hepatic Impairment (Child-Pugh B) With Genotype 1b Chronic Hepatitis C Infection

Conditions: Hepatitis C, Chronic
Being tested: Ribavirin, BI 207127 high dose, Faldaprevir, BI 207127 low dose
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.

RibavirinDrug
24 Weeks
BI 207127 high doseDrug
24 Weeks
FaldaprevirDrug
24 Weeks
RibavirinDrug
24 Weeks
BI 207127 low doseDrug
24 Weeks
FaldaprevirDrug
24 Weeks

Study groups in NCT01830127
Study group	Role	What they receive
cohort A CPA	Experimental	Cohort A CPA BI 207127/QD Faldaprevir Ribavirin Receives: Drug: Ribavirin; Drug: Faldaprevir; Drug: BI 207127 low dose
cohort A CPB	Experimental	Cohort B CPB BI 207127/QD Faldaprevir Ribavirin Receives: Drug: BI 207127 high dose; Drug: Ribavirin; Drug: Faldaprevir

What is being measured

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

SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.
Measured: 12 weeks after End of Treatment

Secondary outcomes (1)

SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)
Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage.
Measured: 4 weeks after End of Treatment

Timeline

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

Apr 2013Oct 2014

First posted12 Apr 2013 (estimated)
Study startApr 2013
Primary completionOct 2014
Study completionOct 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 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01830127
Sponsor's protocol ID: 1241.30
Other IDs: 2012-003534-17
Status last verified: Oct 2015
First submitted: 22 Mar 2013
Last updated: 20 Nov 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Sarrazin C, Manns M, Calleja JL, Garcia-Samaniego J, Forns X, Kaste R, Bai X, Wu J, Stern JO. HCVerso3: An Open-Label, Phase IIb Study of Faldaprevir and Deleobuvir with Ribavirin in Hepatitis C Virus Genotype-1b-Infected Patients with Cirrhosis and Moderate Hepatic Impairment. PLoS One. 2016 Dec 28;11(12):e0168544. doi: 10.1371/journal.pone.0168544. eCollection 2016.
PubMed 28030579

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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Evaluation of Patients With Liver Disease
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Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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RecruitingObservational study
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Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
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All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb Open Label Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Patients With Moderate Hepatic Impairment (Child-Pugh B) With Genotype 1b Chronic Hepatitis C Infection
ClinicalTrials.gov ID: NCT01830127
Acronym / sponsor ID: 1241.30
Conditions: Hepatitis C, Chronic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 12 Apr 2013 (estimated)
Results: Posted 20 Nov 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
cohort A CPA	Experimental	Drug: Ribavirin, Drug: Faldaprevir, Drug: BI 207127 low doseCohort A CPA BI 207127/QD Faldaprevir Ribavirin
cohort A CPB	Experimental	Drug: BI 207127 high dose, Drug: Ribavirin, Drug: FaldaprevirCohort B CPB BI 207127/QD Faldaprevir Ribavirin

Who may qualify

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

Key inclusion criteria (3 listed)

Treatment naïve and treatment experienced patients (prior relapse, interferon intolerant, and [allowed in Cohort A only] prior partial response).
Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only.
Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver stiffness of =13 kPa on fibroscan.

Key exclusion criteria (4 listed)

HCV infection of mixed genotype (1/2, 1/3, and 1/4) or mixed sub-GT1a/1b or undefined diagnosed by genotypic testing at screening
Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases.
HIV infection
Patients who have been previously treated with an investigational or approved DAA

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
Ribavirin24 Weeks	Drug	cohort A CPA
BI 207127 high dose24 Weeks	Drug	cohort A CPB
Faldaprevir24 Weeks	Drug	cohort A CPA
Ribavirin24 Weeks	Drug	cohort A CPB
BI 207127 low dose24 Weeks	Drug	cohort A CPA
Faldaprevir24 Weeks	Drug	cohort A CPB

Primary outcome

SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
Time frame: 12 weeks after End of Treatment
Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.

1 secondary outcome

SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)
Time frame: 4 weeks after End of Treatment

Results and safety

Results posted to the registry on 20 Nov 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
Arm1: Child-Pugh A	18	13
Arm2: Child-Pugh B	17	8

Primary outcome: SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)

Time frame: 12 weeks after End of Treatment. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Arm1: Child-Pugh A n = 18	Arm2: Child-Pugh B n = 17
Value	61.1 (38.6 to 83.6)	52.9 (29.2 to 76.7)

Population analysed: (Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first drug administration until last drug administration plus 28 days, up to 28 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm1: Child-Pugh A	1 of 18 (5.6%)	17 of 18 (94.4%)	Not reported
Arm2: Child-Pugh B	9 of 17 (52.9%)	17 of 17 (100%)	Not reported

Limitations and caveats (from the sponsor): Because the company decided to stop the DBV development program, analyses for this trial were limited to the basic requirement for efficacy, and only the primary endpoint and secondary endpoint were analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28030579Sarrazin C, Manns M, Calleja JL, Garcia-Samaniego J, Forns X, Kaste R, Bai X, Wu J, Stern JO. HCVerso3: An Open-Label, Phase IIb Study of Faldaprevir and Deleobuvir with Ribavirin in Hepatitis C Virus Genotype-1b-Infected Patients with Cirrhosis and Moderate Hepatic Impairment. PLoS One. 2016 Dec 28;11(12):e0168544. doi: 10.1371/journal.pone.0168544. eCollection 2016.
Related InfoLink provided by the sponsor.

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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Active, not recruitingPhase 4
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Enrolling by invitationObservational 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

19 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ribavirin, BI 207127 high dose and Faldaprevir in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 19 sites in 4 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 3 inclusion and 4 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany, United States, Spain, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 20 Nov 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?

SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT) (time frame: 12 weeks after End of Treatment). 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 NCT01830127, 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 20 Nov 2015.