Hepatitis CPhase 2NCT00947349

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients

A Phase 2 study testing ribavirin (RBV), pegylated interferon (PegIFN) alfa-2a and BI 201335 NA high in people with Hepatitis C and Pharmacokinetics, run by Boehringer Ingelheim at 3 sites in Japan.

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 current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose… Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Hepatitis C, Pharmacokinetics
What is being tested?: ribavirin (RBV), pegylated interferon (PegIFN) alfa-2a and BI 201335 NA high
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 3 sitesJapan
Study dates: Jul 2009to Aug 2011
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 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

chronic HCV genotype-1;
high viral load

Who cannot join

Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening
Previous treatment with protease inhibitor

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

1220.14.003 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama
1220.14.001 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo
1220.14.002 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo

Other trials in Japan

About this study

Official title: Safety, Pharmacokinetics and Antiviral Effect of BI 201335 NA in HCV-1 Infected Patients Treated for 28 Days for Treatment naïve and Experienced Patients Treated in Combination With Peg Interferon Alfa-2a and Ribavirin

A number of compounds with direct activity are currently under clinical development, incl. BI 201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN and RBV in HCV infected patients

Conditions: Hepatitis C, Pharmacokinetics
Being tested: ribavirin (RBV), pegylated interferon (PegIFN) alfa-2a, BI 201335 NA low placebo, BI 201335 NA high, BI 201335 NA low
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ribavirin (RBV)Drug
ribavirin (RBV)
pegylated interferon (PegIFN) alfa-2aDrug
pegylated interferon (PegIFN) alfa-2a
pegylated interferon (PegIFN) alfa-2aDrug
pegylated interferon (PegIFN) alfa-2a
ribavirin (RBV)Drug
ribavirin (RBV)
BI 201335 NA low placeboDrug
Placebo
pegylated interferon (PegIFN) alfa-2aDrug
pegylated interferon (PegIFN) alfa-2a
ribavirin (RBV)Drug
ribavirin (RBV)
BI 201335 NA highDrug
BI 201335 NA high
BI 201335 NA lowDrug
BI 201335 NA
BI 201335 NA high placeboDrug
placebo
BI 201335 NA highDrug
BI 201335 NA high
PlaceboDrug

Study groups in NCT00947349
Study group	Role	What they receive
BI 201335 NA low TN	Experimental	patient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients Receives: Drug: pegylated interferon (PegIFN) alfa-2a; Drug: BI 201335 NA low placebo; Drug: ribavirin (RBV); Drug: BI 201335 NA low
BI 201335 NA high TN	Experimental	patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients Receives: Drug: ribavirin (RBV); Drug: pegylated interferon (PegIFN) alfa-2a; Drug: BI 201335 NA high; Drug: BI 201335 NA high placebo
BI 201335 NA high TE	Experimental	patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-experienced (TE) patients Receives: Drug: pegylated interferon (PegIFN) alfa-2a; Drug: ribavirin (RBV); Drug: BI 201335 NA high
Placebo in Treatment Naive (TN) Patients	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Measured: 4 weeks
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.
Measured: 4 weeks
Assessment of Tolerability in Triple Combination Therapy
An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.
Measured: 4 weeks

Secondary outcomes (30)

Week 2 Virological Response (W2VR)
Number of patients satisfying W2VR (plasma HCV RNA (Hepatitis C Virus Ribonucleic acid) level below the limit of quantification (BLQ))
Measured: 2 weeks
Week 4 Virological Response (W4VR)
Number of patients satisfying W4VR (plasma HCV RNA level below the limit of quantification (BLQ))
Measured: 4 weeks
Rapid Virological Response (RVR)
Number of patients satisfying RVR (plasma HCV RNA level below the limit of detection (BLD) at Week 4)
Measured: 4 weeks
Change From Baseline in HCV Viral Load
Change form baseline in HCV viral load (log10) after 4 weeks
Measured: baseline and week 4
Day 28 Virologic Response
Number of patients with HCV viral load reduction >= 2 log10 at Week 4
Measured: 4 weeks
Early Virological Response (EVR)
Number of patients with reduction >= 2 log10 in plasma HCV RNA level at Week 12
Measured: 12 Weeks
Complete Early Virological Response (cEVR)
Number of patients with plasma HCV RNA level BLD at Week 12
Measured: 12 weeks
End of Treatment Response (ETR)
Number of patients with plasma HCV RNA level BLD at week 48
Measured: 48 weeks
Sustained Virologic Response (SVR)
Number of patients with plasma HCV RNA level BLD 24 weeks after treatment completion
Measured: 72 weeks
Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV
Drug-related AEs in SOC treatment period were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Measured: 44 weeks
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in SOC period for treatment naive patients and treatment experienced patients.
Measured: 44 weeks
Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV
An assessment of tolerability for the safety of the SOC with PegIFN alfa-2a and RBV.
Measured: 44 weeks
AUCτ,1 for BI 201335 ZW
Area under the curve (AUC) concentration after the first dose of BI 201335 ZW
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Cmax of BI 201335 ZW
Maximum concentration of BI 201335 ZW after multiple oral admin. of BI 201335 NA with RBV and PegIFN alfa-2a
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
AUCτ,ss of BI 201335 ZW
AUC at steady state after 4 weeks combination of the last dose
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cmax,ss of BI 201335 ZW
Maximum concentration of BI 201335 ZW at steady state
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
AUCτ,1 for Ribavirin (RBV)
Area under the plasma concentration curve of RBV after the first dose of placebo or BI 201335 NA with with RBV and PegIFN alfa-2a
Measured: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose
Cmax of RBV
Maximum Plasma concentration of RBV after multiple oral admin. of placebo with RBV and PegIFN alfa-2a
Measured: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose
AUCτ,ss of RBV
Area under the plasma concentration curve of RBV after the multiple oral administration of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state
Measured: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose
Cmax,ss of RBV
Maximum Plasma concentration of RBV after multiple oral admin. of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state
Measured: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose
Tmax for BI 201335 ZW
Time to maximum plasma concentration (tmax) of BI 201335 ZW after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Tmax for RBV
Time to maximum plasma concentration (tmax) of RBV after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Tmax, ss for BI 201335 ZW
Time from last dosing to the maximum plasma concentration (tmax) of BI 201335 ZW after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Tmax, ss for RBV
Time to the maximum plasma concentration (tmax) of RBV after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
t1/2,ss for BI 201335 ZW
terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cmin,ss for BI 201335 ZW
Minimum concentration of the analyte (BI 201335 ZW) in plasma over the dosing interval at steady state
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cmin,ss for RBV
Minimum concentration of the analyte (RBV) in plasma over the dosing interval at steady state
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cavg for BI 201335 ZW
average plasma concentration (Cavg) of BI 201335 ZW
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cavg for RBV
average plasma concentration (Cavg) of RBV
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
CL/F,ss for BI 201335 ZW
apparent clearance of the analyte (BI 201335 ZW) in plasma at steady state (CL/F,ss) following multiple oral administration
Measured: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

Timeline

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

Jul 2009Aug 2011

First posted28 Jul 2009 (estimated)
Study startJul 2009
Primary completionAug 2011
Study completionAug 2011

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.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00947349
Sponsor's protocol ID: 1220.14
Status last verified: Jul 2015
First submitted: 21 Jul 2009
Last updated: 7 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

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

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

Questions to ask the study team

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

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Pharmacokinetics and Antiviral Effect of BI 201335 NA in HCV-1 Infected Patients Treated for 28 Days for Treatment naïve and Experienced Patients Treated in Combination With Peg Interferon Alfa-2a and Ribavirin
ClinicalTrials.gov ID: NCT00947349
Acronym / sponsor ID: 1220.14
Conditions: Hepatitis C, Pharmacokinetics
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 28 Jul 2009 (estimated)
Results: Posted 7 Jul 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
BI 201335 NA low TN	Experimental	Drug: pegylated interferon (PegIFN) alfa-2a, Drug: BI 201335 NA low placebo, Drug: ribavirin (RBV), Drug: BI 201335 NA lowpatient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients
BI 201335 NA high TN	Experimental	Drug: ribavirin (RBV), Drug: pegylated interferon (PegIFN) alfa-2a, Drug: BI 201335 NA high, Drug: BI 201335 NA high placebopatient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients
BI 201335 NA high TE	Experimental	Drug: pegylated interferon (PegIFN) alfa-2a, Drug: ribavirin (RBV), Drug: BI 201335 NA highpatient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-experienced (TE) patients
Placebo in Treatment Naive (TN) Patients	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

chronic HCV genotype-1;
high viral load

Key exclusion criteria (2 listed)

Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening
Previous treatment with protease inhibitor

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)ribavirin (RBV)	Drug	BI 201335 NA high TN
pegylated interferon (PegIFN) alfa-2apegylated interferon (PegIFN) alfa-2a	Drug	BI 201335 NA low TN
pegylated interferon (PegIFN) alfa-2apegylated interferon (PegIFN) alfa-2a	Drug	BI 201335 NA high TE
ribavirin (RBV)ribavirin (RBV)	Drug	BI 201335 NA high TE
BI 201335 NA low placeboPlacebo	Drug	BI 201335 NA low TN
pegylated interferon (PegIFN) alfa-2apegylated interferon (PegIFN) alfa-2a	Drug	BI 201335 NA high TN
ribavirin (RBV)ribavirin (RBV)	Drug	BI 201335 NA low TN
BI 201335 NA highBI 201335 NA high	Drug	BI 201335 NA high TN
BI 201335 NA lowBI 201335 NA	Drug	BI 201335 NA low TN
BI 201335 NA high placeboplacebo	Drug	BI 201335 NA high TN
BI 201335 NA highBI 201335 NA high	Drug	BI 201335 NA high TE
Placebo	Drug	Placebo in Treatment Naive (TN) Patients

Primary outcome

Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy
Time frame: 4 weeks
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Time frame: 4 weeks
Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.
Assessment of Tolerability in Triple Combination Therapy
Time frame: 4 weeks
An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.

30 secondary outcomes

Week 2 Virological Response (W2VR)
Time frame: 2 weeks
Week 4 Virological Response (W4VR)
Time frame: 4 weeks
Rapid Virological Response (RVR)
Time frame: 4 weeks
Change From Baseline in HCV Viral Load
Time frame: baseline and week 4
Day 28 Virologic Response
Time frame: 4 weeks
Early Virological Response (EVR)
Time frame: 12 Weeks
Complete Early Virological Response (cEVR)
Time frame: 12 weeks
End of Treatment Response (ETR)
Time frame: 48 weeks
Sustained Virologic Response (SVR)
Time frame: 72 weeks
Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV
Time frame: 44 weeks
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Time frame: 44 weeks
Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV
Time frame: 44 weeks
AUCτ,1 for BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Cmax of BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
AUCτ,ss of BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cmax,ss of BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
AUCτ,1 for Ribavirin (RBV)
Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose
Cmax of RBV
Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose
AUCτ,ss of RBV
Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose
Cmax,ss of RBV
Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose
Tmax for BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Tmax for RBV
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Tmax, ss for BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Tmax, ss for RBV
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
t1/2,ss for BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cmin,ss for BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cmin,ss for RBV
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cavg for BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cavg for RBV
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
CL/F,ss for BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

Results and safety

Results posted to the registry on 7 Jul 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
Placebo in Treatment Naive (TN) Patients	4	4
BI 201335 NA Low for Treatment Naive (TN)	6	5
BI 201335 NA High TN	6	6
BI 201335 NA High for Treatment Experienced (TE)	6	6

Primary outcome: Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy

Time frame: 4 weeks. Number. Unit: participants

Measure	Triple TN Placebo n = 4	Triple TN 120 mg n = 6	Triple TN 240 mg n = 6	Triple TE 240 mg n = 6
Value	3	6	6	5

Population analysed: The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomization randomisation.

Primary outcome: Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy

Time frame: 4 weeks. Number. Unit: participants

Measure	Triple TN Placebo n = 4	Triple TN 120 mg n = 6	Triple TN 240 mg n = 6	Triple TE 240 mg n = 6
Decrease Haematocrit	2	2	3	4
Decrease Haemoglobin	3	3	2	4
Decrease Red blood cell ct.	1	2	2	2
Decrease White blood cell ct.	2	4	5	4
Decrease Platelets	0	1	0	0
Increase Eosinophils	0	0	1	0
Decrease Sodium	1	2	2	1
Decrease Potassium	0	0	1	0

Primary outcome: Assessment of Tolerability in Triple Combination Therapy

Time frame: 4 weeks. Number. Unit: participants

Measure	Triple TN Placebo n = 4	Triple TN 120 mg n = 6	Triple TN 240 mg n = 6	Triple TE 240 mg n = 6
Good	3	5	5	6
Satisfactory	0	1	1	0
Not Satisfactory	1	0	0	0
Bad	0	0	0	0

30 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 72 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Triple TN Placebo	0 of 4 (0%)	3 of 4 (75%)	Not reported
Triple TN 120 mg	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
Triple TN 240 mg	0 of 6 (0%)	6 of 6 (100%)	Not reported
Triple TE 240 mg	0 of 6 (0%)	6 of 6 (100%)	Not reported
SOC TN Placebo	1 of 4 (25%)	3 of 4 (75%)	Not reported
SOC TN 120 mg	0 of 5 (0%)	5 of 5 (100%)	Not reported
SOC TN 240 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
SOC TE 240 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported

Limitations and caveats (from the sponsor): Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ribavirin (RBV), pegylated interferon (PegIFN) alfa-2a and BI 201335 NA high in people with Hepatitis C and Pharmacokinetics, run by Boehringer Ingelheim at 3 sites in Japan.

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 2 inclusion and 2 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 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 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 7 Jul 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?

Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy (time frame: 4 weeks). The study lists 3 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 NCT00947349.

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 7 Jul 2015.