Hepatitis C, ChronicPhase 1NCT00905632
4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients
A Phase 1 study testing BI 207127 middle dose +SOC, BI 207127 high dose+SOC and BI 207127 low dose + SOC in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 18 sites in 3 countries.
Trial summary
The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients. 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?
- BI 207127 middle dose +SOC, BI 207127 high dose+SOC and BI 207127 low dose + SOC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 18 sitesin 3 countries
- Study dates
- May 2009to Mar 2011
- Phase
- Phase 1
- 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
- HCV genotype 1
- HCV viral load >100,000 IU/mL
- histology or fibroscan to rule out cirrhosis
- Absence of retinopathy
- treatment naive patients and treatment experienced patients
- Age 18 - 70 years
- Male OR female with documented hysterectomy OR postmenopausal
Who cannot join
- Fertile males not willing to use an adequate form of contraception
- Pretreatment with any HCV-polymerase inhibitor
- Any concurrent disease if clinically significant based on the investigator's medical assessment
- Current alcohol or drug abuse, or history of the same
- Positive test for HIV or HBs
- History of malignancy
Show all 11Show fewer
- Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination
- Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer
- Any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
- Patients treated with any interferon (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening
- Known hypersensitivity to drugs or excipients; Further exclusion criteria apply
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
Germany8 sites
1241.7.49010 Boehringer Ingelheim Investigational Site
Aachen
1241.7.49012 Boehringer Ingelheim Investigational Site
Berlin
1241.7.49004 Boehringer Ingelheim Investigational Site
Essen
1241.7.49011 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1241.7.49001 Boehringer Ingelheim Investigational Site
Hamburg
1241.7.49013 Boehringer Ingelheim Investigational Site
Mainz
1241.7.49009 Boehringer Ingelheim Investigational Site
Regensburg
1241.7.49002 Boehringer Ingelheim Investigational Site
Ulm
France7 sites
1241.7.3307A CHU de Grenoble
Grenoble Cédex 9
1241.7.3303A Hôpital Claude Huriez
Lille
1241.7.3302A Hopital de l'Hotel Dieu
Lyon
1241.7.3301A Hôpital Saint Eloi
Montpellier
1241.7.3305A HOP Archet 2
Nice
1241.7.3306A Hôpital Haut-Lévêque
Pessac
1241.7.3304A HOP de Brabois
Vandœuvre-lès-Nancy
Switzerland3 sites
1241.7.41003 Boehringer Ingelheim Investigational Site
Basel
1241.7.41004 Boehringer Ingelheim Investigational Site
Lugano
1241.7.41001 Boehringer Ingelheim Investigational Site
Sankt Gallen
About this study
Official title: Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA Administered in Combination With Peg-IFN and Ribavirin in Chronic HCV-infected Patients for 4 Weeks, a Randomised, Double-blind, Placebo Controlled Study
The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.
- Conditions
- Hepatitis C, Chronic
- Being tested
- BI 207127 middle dose +SOC, BI 207127 high dose+SOC, Placebo + SOC, BI 207127 low dose + SOC
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 207127 middle dose +SOCDrug
BI 207127 middle dose tid + SOC
BI 207127 high dose+SOCDrug
BI 207127 high dose tid +SOC
Placebo + SOCDrug
Placebo tid +SOC
BI 207127 low dose + SOCDrug
BI 207127 low dose tid + SOC
| Study group | Role | What they receive |
|---|---|---|
| BI 207127 low dose + SOC | Experimental | BI 207127 low dose tid + SOC Receives: Drug: BI 207127 low dose + SOC |
| BI 207127 middle dose +SOC | Experimental | BI 207127 middle dose tid + SOC Receives: Drug: BI 207127 middle dose +SOC |
| BI 207127 high dose+SOC | Experimental | BI 207127 high dose tid +SOC Receives: Drug: BI 207127 high dose+SOC |
| Placebo + SOC | Placebo comparator | Placebo tid +SOC Receives: Drug: Placebo + SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir.
The primary efficacy endpoint is the number of participants with virologic response defined as >= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as >= 1 log increase in viral load from nadir.
Measured: Baseline and 4 weeks
Secondary outcomes (20)
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline
Reductions of viral load (Log10) at each visit up to day 28, change from baseline. Change from baseline was calculated as the value at baseline minus the value at each later visit.
A negative value represents an increase in viral load, a positive value represents a decrease in viral load.
Measured: Baseline and days 1, 2, 4, 8, 15, 22 and 28
Viral Load at Each Visit up to Day 28
Viral load (VL) (original values) at each visit up to day 28.
Measured: Baseline and days 8, 15, 22 and 28
Number of Participants With Virologic Response at Day 28
Number of participants with virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ), <10 IU/mL, at day 28
Measured: day 28
Number of Participants With Rapid Virological Response
Number of participants with rapid virological response - defined as serum Hepatitis C virus (HCV) RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/High Pure System (HPS) for extraction assay (10 IU/mL) on Day 28.
Measured: 4 weeks
Number of Participants With Early Virological Response
Number of participants with early virological response (EVR) defined as at least 2log10 reduction in HCV Ribonucleic acid (RNA) from baseline at Week 12. Number of responders* - Response = At least a 2 log10 reduction in viral load from baseline at Week 12 (Day 84)
Measured: Baseline and week 12
Number of Participants With End of Treatment Response
Number of participants with end of treatment response (ETR) - defined as serum HCV RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at end of treatment (including 5-day washout). Number of responders* - Response = Viral load below the limit of detection at end of all treatment.
Measured: Week 12
Number of Participants With Sustained Virological Response
Number of participants with sustained virological response. Sustained virological response was defined as serum HCV RNA below the limit of detection (<10 IU/mL) at least 85 days after stopping standard care (SOC).
Measured: Until end of treatment, up to 570 days
Plasma Concentration Time Profiles of BI 207127
Plasma concentration time profiles of BI 207127
Measured: 0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration
Plasma Concentration Time Profiles of CD 6168
Plasma concentration time profiles of CD 6168
Measured: 0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration
Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)
Maximum measured concentration of the analyte in plasma (Cmax) after first dose on day 1 (Cmax) and after last dose (steady state) on day 28 (Cmax,ss) of BI 207127 and CD 6168
Measured: 5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)
tmax [h] Time from (last) dosing to the maximum measured concentration of the analyte in plasma after first dose on day 1 and after last dose on day 28 (steady state).
Measured: 5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)
Area under the concentration-time curve of the analyte in plasma (AUC) after first dose on day 1 (AUC0-6) and after last dose on day 28 (AUC0-6,ss) of BI 207127 and CD 6168
Measured: 30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168
Cpre,N [ng/mL] - Predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered for BI 207127 and CD 6168. Descriptive statistics were calculated only if at least 2/3 plasma concentrations were available. All values for Cpre,1 were not available, therefore no results are presented below.
Measured: 5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27
C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose
C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. C6,ss is the concentration 6 hours after dosing at steady-state (reported as 654 h).
Measured: 654 hours after drug administration on day 28
AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose
Area under the concentration time curve of the analyte in plasma over the time interval of 0 to infinity at steady state (AUC0-infinity,ss): Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State (SS) After the Last Dose
Measured: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose
Terminal rate constant in plasma (λz): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose
Measured: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose
Terminal half-life of the analyte in plasma at steady state (t1/2,ss) and mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose
Measured: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose
Accumulation ratio of maximum measured concentration of the analyte in plasma (RA,Cmax): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. Ratio was calculated as Cmax,ss divided by Cmax.
Measured: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG
Number of participants with clinically relevant abnormalities for vital signs, blood chemistry, body temperature, physical examination, haematology, coagulation, urinalysis and electrocardiography (ECG). New abnormal findings or worsening of baseline conditions were reported as adverse events.
Measured: From the start of the study to Day 30 (2 days after last dose)
Number of Participants With Discontinuations Due to AEs
Number of participants with adverse events (AEs) leading to discontinuation of trial drug
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startMay 2009
- Primary completionMar 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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905632
- Sponsor's protocol ID
- 1241.7
- Other IDs
- 2008-008292-34, 2008
- Status last verified
- Mar 2016
- First submitted
- 19 May 2009
- Last updated
- 19 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Larrey D, Lohse AW, de Ledinghen V, Trepo C, Gerlach T, Zarski JP, Tran A, Mathurin P, Thimme R, Arasteh K, Trautwein C, Cerny A, Dikopoulos N, Schuchmann M, Heim MH, Gerken G, Stern JO, Wu K, Abdallah N, Girlich B, Scherer J, Berger F, Marquis M, Kukolj G, Bocher W, Steffgen J. Rapid and strong antiviral activity of the non-nucleosidic NS5B polymerase inhibitor BI 207127 in combination with peginterferon alfa 2a and ribavirin. J Hepatol. 2012 Jul;57(1):39-46. doi: 10.1016/j.jhep.2012.02.015. Epub 2012 Mar 10.
PubMed 22414766
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA Administered in Combination With Peg-IFN and Ribavirin in Chronic HCV-infected Patients for 4 Weeks, a Randomised, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00905632
- Acronym / sponsor ID
- 1241.7
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Mar 2011 (actual)
- First posted
- 20 May 2009 (estimated)
- Results
- Posted 19 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 main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 207127 low dose + SOC | Experimental | Drug: BI 207127 low dose + SOCBI 207127 low dose tid + SOC |
| BI 207127 middle dose +SOC | Experimental | Drug: BI 207127 middle dose +SOCBI 207127 middle dose tid + SOC |
| BI 207127 high dose+SOC | Experimental | Drug: BI 207127 high dose+SOCBI 207127 high dose tid +SOC |
| Placebo + SOC | Placebo comparator | Drug: Placebo + SOCPlacebo tid +SOC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HCV genotype 1
- HCV viral load >100,000 IU/mL
- histology or fibroscan to rule out cirrhosis
- Absence of retinopathy
- treatment naive patients and treatment experienced patients
Key exclusion criteria (11 listed)
- Fertile males not willing to use an adequate form of contraception
- Pretreatment with any HCV-polymerase inhibitor
- Any concurrent disease if clinically significant based on the investigator's medical assessment
- Current alcohol or drug abuse, or history of the same
- Positive test for HIV or HBs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 207127 middle dose +SOCBI 207127 middle dose tid + SOC | Drug | BI 207127 middle dose +SOC |
| BI 207127 high dose+SOCBI 207127 high dose tid +SOC | Drug | BI 207127 high dose+SOC |
| Placebo + SOCPlacebo tid +SOC | Drug | Placebo + SOC |
| BI 207127 low dose + SOCBI 207127 low dose tid + SOC | Drug | BI 207127 low dose + SOC |
Primary outcome
Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir.
Time frame: Baseline and 4 weeks
The primary efficacy endpoint is the number of participants with virologic response defined as >= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as >= 1 log increase in viral load from nadir.
20 secondary outcomes
Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline
Time frame: Baseline and days 1, 2, 4, 8, 15, 22 and 28
Viral Load at Each Visit up to Day 28
Time frame: Baseline and days 8, 15, 22 and 28
Number of Participants With Virologic Response at Day 28
Time frame: day 28
Number of Participants With Rapid Virological Response
Time frame: 4 weeks
Number of Participants With Early Virological Response
Time frame: Baseline and week 12
Number of Participants With End of Treatment Response
Time frame: Week 12
Number of Participants With Sustained Virological Response
Time frame: Until end of treatment, up to 570 days
Plasma Concentration Time Profiles of BI 207127
Time frame: 0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration
Plasma Concentration Time Profiles of CD 6168
Time frame: 0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration
Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)
Time frame: 5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)
Time frame: 5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)
Time frame: 30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28
Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168
Time frame: 5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27
C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose
Time frame: 654 hours after drug administration on day 28
AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose
Time frame: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose
Time frame: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose
Time frame: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose
Time frame: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28
Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG
Time frame: From the start of the study to Day 30 (2 days after last dose)
Number of Participants With Discontinuations Due to AEs
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22414766Larrey D, Lohse AW, de Ledinghen V, Trepo C, Gerlach T, Zarski JP, Tran A, Mathurin P, Thimme R, Arasteh K, Trautwein C, Cerny A, Dikopoulos N, Schuchmann M, Heim MH, Gerken G, Stern JO, Wu K, Abdallah N, Girlich B, Scherer J, Berger F, Marquis M, Kukolj G, Bocher W, Steffgen J. Rapid and strong antiviral activity of the non-nucleosidic NS5B polymerase inhibitor BI 207127 in combination with peginterferon alfa 2a and ribavirin. J Hepatol. 2012 Jul;57(1):39-46. doi: 10.1016/j.jhep.2012.02.015. Epub 2012 Mar 10.
- 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
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 207127 middle dose +SOC, BI 207127 high dose+SOC and BI 207127 low dose + SOC in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 18 sites in 3 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 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 19 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 18 sites in Germany, France, Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 19 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?
Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. (time frame: Baseline and 4 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 NCT00905632, 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 19 Apr 2016; AzTrials last refreshed its copy on 7 Nov 2026.