Hepatitis C, ChronicPhase 3NCT01399619

Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

A Phase 3 study testing PegIFN/RBV, BI201335 and BI201335 24W in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 71 sites in 8 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 this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: PegIFN/RBV, BI201335 and BI201335 24W
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 310 participants
Where: 71 sitesin 8 countries
Study dates: Sep 2011to Jun 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 (HCV) genotype 1 infection
Chronic Human Immunodeficiency Virus (HIV) -1 infection
HCV treatment naive or HCV treatment experienced but only relapsers
Age 18 to 70 years
Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART)
Karnofsky score >70
HCV viral load >1.000 IU/mL

Who cannot join

HCV infection of mixed genotype (1/2, 1/3, 1/4)
Evidence of acute or chronic liver due to chronic HCV infection
Hepatitis B virus (HBV) infection with presence of HBs-Ag
Active malignancy or history or malignancy within the last 5 years
Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment.
Decompensated liver disease,as evidenced by ascites, hepatic encephalopathy, esophageal variceal bleeding, and/or laboratory values that add up to >/= 7 points according tho the Child-Turcotte-Pugh classification

Show all 9Show fewer

Hemoglobin </=11g/dL for women and </= 12 g/dL for men
Patients with stable cardiac disease and Hemoglobin <12g/dL
Known hypersensitivity to any ingredient of the study drugs

Trial locations and contacts

71 sites in 8 countries.

Country

City, postcode or hospital

71 sites in 8 countries

United States22 sites

1220.19.0011 Boehringer Ingelheim Investigational Site
Albany, New York
1220.19.0029 Boehringer Ingelheim Investigational Site
Austin, Texas
1220.19.0045 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1220.19.0008 Boehringer Ingelheim Investigational Site
Camden, New Jersey
1220.19.0012 Boehringer Ingelheim Investigational Site
Dallas, Texas
1220.19.0086 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1220.19.0060 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
1220.19.0027 Boehringer Ingelheim Investigational Site
Framingham, Massachusetts
1220.19.0009 Boehringer Ingelheim Investigational Site
Hillsborough, New Jersey
1220.19.0079 Boehringer Ingelheim Investigational Site
Lutherville, Maryland
1220.19.0006 Boehringer Ingelheim Investigational Site
New York, New York
1220.19.0014 Boehringer Ingelheim Investigational Site
New York, New York
1220.19.0084 Boehringer Ingelheim Investigational Site
New York, New York
1220.19.0044 Boehringer Ingelheim Investigational Site
Orlando, Florida
1220.19.0007 Boehringer Ingelheim Investigational Site
Palm Springs, California
1220.19.0013 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1220.19.0026 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1220.19.0016 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1220.19.0031 Boehringer Ingelheim Investigational Site
San Francisco, California
1220.19.0004 Boehringer Ingelheim Investigational Site
Vero Beach, Florida
1220.19.0005 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
1220.19.0021 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

Germany9 sites

1220.19.4902 Boehringer Ingelheim Investigational Site
Berlin
1220.19.4921 Boehringer Ingelheim Investigational Site
Berlin
1220.19.4901 Boehringer Ingelheim Investigational Site
Bonn
1220.19.4924 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1220.19.4919 Boehringer Ingelheim Investigational Site
Hamburg
1220.19.4920 Boehringer Ingelheim Investigational Site
Hamburg
1220.19.4905 Boehringer Ingelheim Investigational Site
München
1220.19.4922 Boehringer Ingelheim Investigational Site
München
1220.19.4923 Boehringer Ingelheim Investigational Site
Würzburg

Other trials in Germany

Spain9 sites

1220.19.3404 Boehringer Ingelheim Investigational Site
Badalona
1220.19.3401 Boehringer Ingelheim Investigational Site
Barcelona
1220.19.3403 Boehringer Ingelheim Investigational Site
Barcelona
1220.19.3409 Boehringer Ingelheim Investigational Site
Barcelona
1220.19.3402 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1220.19.3405 Boehringer Ingelheim Investigational Site
Madrid
1220.19.3406 Boehringer Ingelheim Investigational Site
Madrid
1220.19.3407 Boehringer Ingelheim Investigational Site
Madrid
1220.19.3408 Boehringer Ingelheim Investigational Site
Seville

Other trials in Spain

United Kingdom8 sites

1220.19.4406 Boehringer Ingelheim Investigational Site
Brighton
1220.19.4407 Boehringer Ingelheim Investigational Site
Edinburgh
1220.19.4401 Boehringer Ingelheim Investigational Site
London
1220.19.4402 Boehringer Ingelheim Investigational Site
London
1220.19.4403 Boehringer Ingelheim Investigational Site
London
1220.19.4404 Boehringer Ingelheim Investigational Site
London
1220.19.4408 Boehringer Ingelheim Investigational Site
London
1220.19.4405 Boehringer Ingelheim Investigational Site
Manchester

Other trials in United Kingdom

Italy7 sites

1220.19.3901 Boehringer Ingelheim Investigational Site
Antella (fi)
1220.19.3902 Boehringer Ingelheim Investigational Site
Bari
1220.19.3906 Boehringer Ingelheim Investigational Site
Brescia
1220.19.3907 Boehringer Ingelheim Investigational Site
Milan
1220.19.3905 Boehringer Ingelheim Investigational Site
Pavia
1220.19.3903 Boehringer Ingelheim Investigational Site
Roma
1220.19.3904 Boehringer Ingelheim Investigational Site
Torino

Other trials in Italy

Brazil6 sites

1220.19.5508 Boehringer Ingelheim Investigational Site
Rio de Janeiro
1220.19.5502 Boehringer Ingelheim Investigational Site
Rio de Janeiro - RJ
1220.19.5506 Boehringer Ingelheim Investigational Site
Salvador
1220.19.5503 Boehringer Ingelheim Investigational Site
São Paulo
1220.19.5505 Boehringer Ingelheim Investigational Site
São Paulo
1220.19.5501 Boehringer Ingelheim Investigational Site
São Paulo - SP

Other trials in Brazil

France6 sites

1220.19.3306 Boehringer Ingelheim Investigational Site
Lyon
1220.19.3303 Boehringer Ingelheim Investigational Site
Marseille
1220.19.3304 Boehringer Ingelheim Investigational Site
Marseille
1220.19.3301 Boehringer Ingelheim Investigational Site
Paris
1220.19.3305 Boehringer Ingelheim Investigational Site
Paris
1220.19.3307 Boehringer Ingelheim Investigational Site
Paris

Other trials in France

Switzerland4 sites

1220.19.4101 Boehringer Ingelheim Investigational Site
Basel
1220.19.4103 Boehringer Ingelheim Investigational Site
Bern
1220.19.4102 Boehringer Ingelheim Investigational Site
Lugano
1220.19.4104 Boehringer Ingelheim Investigational Site
Zurich

Other trials in Switzerland

About this study

Official title: Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.

Conditions: Hepatitis C, Chronic
Being tested: PegIFN/RBV, BI201335, BI201335 24W, 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.

PegIFN/RBVDrug
PegIFN/RBV for 24 or 48w
PegIFN/RBVDrug
PegIFN/RBV for 24 or 48w
BI201335Drug
BI201335 for 12w
BI201335 24WDrug
BI201335 for 24w
PegIFN/RBVDrug
PegIFN/RBV for 24 or 48w
Bi 201335Drug
BI 201335 for 24 w

Study groups in NCT01399619
Study group	Role	What they receive
BI201335 12W	Experimental	patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks Receives: Drug: PegIFN/RBV; Drug: BI201335
BI 201335 24W	Experimental	patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks Receives: Drug: BI201335 24W; Drug: PegIFN/RBV
BI 201335 24 W	Experimental	patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks Receives: Drug: PegIFN/RBV; Drug: Bi 201335

What is being measured

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

Sustained Virological Response (SVR12)
Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment.
Measured: 60 weeks

Secondary outcomes (10)

Virological Response 24 Weeks Post Treatment (SVR24)
Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment.
Measured: 72 weeks
Early Treatment Success (ETS)
Early Treatment Success (ETS): 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, week 8 and week 60
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes
The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.
Measured: 48 weeks
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no
The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.
Measured: 48 weeks
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes
The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
Measured: 60 weeks
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no
The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.
Measured: 60 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes
The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.
Measured: 48 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no
The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.
Measured: 48 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes
The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
Measured: 60 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no
The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.
Measured: 60 weeks

Timeline

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

Sep 2011Jun 2014

First posted22 Jul 2011 (estimated)
Study startSep 2011
Primary completionSep 2013
Study completionJun 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 310 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01399619
Sponsor's protocol ID: 1220.19
Other IDs: 2010-021734-59
Status last verified: Jul 2016
First submitted: 20 Jul 2011
Last updated: 29 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Dieterich D, Nelson M, Soriano V, Arasteh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon alpha-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.
PubMed 25710287

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
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".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
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
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.
ClinicalTrials.gov ID: NCT01399619
Acronym / sponsor ID: 1220.19
Conditions: Hepatitis C, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 310 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Sep 2013 (actual)
Study completion: Jun 2014 (actual)
First posted: 22 Jul 2011 (estimated)
Results: Posted 4 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: None (open label)
Number of arms: 3

Arm	Type	Receives
BI201335 12W	Experimental	Drug: PegIFN/RBV, Drug: BI201335patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks
BI 201335 24W	Experimental	Drug: BI201335 24W, Drug: PegIFN/RBVpatient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks
BI 201335 24 W	Experimental	Drug: PegIFN/RBV, Drug: Bi 201335patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks

Who may qualify

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

Key inclusion criteria (7 listed)

Chronic hepatitis C (HCV) genotype 1 infection
Chronic Human Immunodeficiency Virus (HIV) -1 infection
HCV treatment naive or HCV treatment experienced but only relapsers
Age 18 to 70 years
Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART)

Key exclusion criteria (9 listed)

HCV infection of mixed genotype (1/2, 1/3, 1/4)
Evidence of acute or chronic liver due to chronic HCV infection
Hepatitis B virus (HBV) infection with presence of HBs-Ag
Active malignancy or history or malignancy within the last 5 years
Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PegIFN/RBVPegIFN/RBV for 24 or 48w	Drug	BI 201335 24 W
PegIFN/RBVPegIFN/RBV for 24 or 48w	Drug	BI201335 12W
BI201335BI201335 for 12w	Drug	BI201335 12W
BI201335 24WBI201335 for 24w	Drug	BI 201335 24W
PegIFN/RBVPegIFN/RBV for 24 or 48w	Drug	BI 201335 24W
Bi 201335BI 201335 for 24 w	Drug	BI 201335 24 W

Primary outcome

Sustained Virological Response (SVR12)
Time frame: 60 weeks
Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment.

10 secondary outcomes

Virological Response 24 Weeks Post Treatment (SVR24)
Time frame: 72 weeks
Early Treatment Success (ETS)
Time frame: Week 4, week 8 and week 60
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes
Time frame: 48 weeks
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no
Time frame: 48 weeks
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes
Time frame: 60 weeks
The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no
Time frame: 60 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes
Time frame: 48 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no
Time frame: 48 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes
Time frame: 60 weeks
The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no
Time frame: 60 weeks

Results and safety

Results posted to the registry on 4 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 -24W	123	98
Faldaprevir 240mg -12W	84	84
Faldaprevir 240mg-24W	86	74
Faldaprevir 240 mg -NR (Prior to Re-randomization at Week 12)	17	0

Primary outcome: Sustained Virological Response (SVR12)

Time frame: 60 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Faldaprevir 120mg - 24W n = 123	Faldaprevir 240mg - 12W n = 84	Faldaprevir 240mg - 24W n = 86	Faldaprevir 240mg -T n = 185	Faldaprevir - Total n = 308
Value	70.7 (62.7 to 78.8)	78.6 (69.8 to 87.3)	76.7 (67.8 to 85.7)	72.4 (66.0 to 78.9)	71.8 (66.7 to 76.8)

Faldaprevir - Total: p <0.0001, normal approximation

Population analysed: FAS

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: from the start date of trial medication up to 52 weeks ( AEs occurred from the start date of trial medication up to four weeks after all treatment discontinuation).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Faldaprevir 120mg - 24W	17 of 123 (13.8%)	116 of 123 (94.3%)	Not reported
Faldaprevir 240mg - 12W	5 of 84 (6%)	80 of 84 (95.2%)	Not reported
Faldaprevir 240mg - 24W	5 of 86 (5.8%)	84 of 86 (97.7%)	Not reported
Faldaprevir 240mg -T	15 of 185 (8.1%)	178 of 185 (96.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25710287Dieterich D, Nelson M, Soriano V, Arasteh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon alpha-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.
Related InfoLink provided by the sponsor.

Related trials for Hepatitis C, Chronic

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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

71 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PegIFN/RBV, BI201335 and BI201335 24W in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 71 sites in 8 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 7 inclusion and 9 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 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Germany, Spain, United Kingdom, Italy and 3 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 4 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained Virological Response (SVR12) (time frame: 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 NCT01399619, 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 29 Aug 2016.