Hepatitis CPhase 2NCT00984620
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
A Phase 2 study testing BI 201335, Pegylated Interferon-alpha (IFN) and Ribavirin (RBV) in people with Hepatitis C, run by Boehringer Ingelheim at 28 sites in 6 countries.
Trial summary
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- BI 201335, Pegylated Interferon-alpha (IFN) and Ribavirin (RBV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 28 sitesin 6 countries
- Study dates
- Sep 2009to Apr 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis C infection of genotype 1
- Therapy-naïve to interferon, pegylated interferon, and ribavirin
- HCV viral load > 100.000 IU/ml at screening
- Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis
- Normal retinal finding on fundoscopy within 6 months prior to Day 1
- Age 18 to 70 years
Who cannot join
- HCV of mixed genotype (1/2, 1/3, and 1/4) .
- Patients who have been previously treated with at least one dose of any protease inhibitor
- Evidence of liver disease due to causes other than chronic HCV infection
- Positive for HIV-1 or HIV-2 antibodies
- Hepatitis B virus (HBV) infection
- Decompensated liver disease, or history of decompensated liver disease
Show all 13Show fewer
- Active malignancy or history of malignancy within the last 5 years
- History of alcohol or drug abuse (except cannabis) within the past 12 months.
- Body Mass Index < 18 or > 35 kg/m2.
- Usage of any investigational drugs within 30 days prior to enrolment
- Alpha fetoprotein value >100ng/mL at screening;
- Total bilirubin > 1.5 x ULN with ratio of direct/indirect > 1.
- ALT or AST level > 10 x ULN
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
United States6 sites
1220.40.005 Boehringer Ingelheim Investigational Site
Austin, Texas
1220.40.006 Boehringer Ingelheim Investigational Site
Germantown, Tennessee
1220.40.004 Boehringer Ingelheim Investigational Site
Jackson, Tennessee
1220.40.003 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
1220.40.007 Boehringer Ingelheim Investigational Site
New York, New York
1220.40.002 Boehringer Ingelheim Investigational Site
Tulepo, Mississippi
France6 sites
1220.40.3303A Boehringer Ingelheim Investigational Site
Clichy
1220.40.3305A Boehringer Ingelheim Investigational Site
Lille
1220.40.3301A Boehringer Ingelheim Investigational Site
Marseille
1220.40.3306A Boehringer Ingelheim Investigational Site
Montpellier
1220.40.3302A Boehringer Ingelheim Investigational Site
Paris
1220.40.3304A Boehringer Ingelheim Investigational Site
Rennes
Germany6 sites
1220.40.4902 Boehringer Ingelheim Investigational Site
Berlin
1220.40.4909 Boehringer Ingelheim Investigational Site
Berlin
1220.40.4906 Boehringer Ingelheim Investigational Site
Düsseldorf
1220.40.4908 Boehringer Ingelheim Investigational Site
Düsseldorf
1220.40.4904 Boehringer Ingelheim Investigational Site
Hamburg
1220.40.4905 Boehringer Ingelheim Investigational Site
Mainz
Canada5 sites
1220.40.1004 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1220.40.1003 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1220.40.1005 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1220.40.1002 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1220.40.1001 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
Romania3 sites
1220.40.4001 Boehringer Ingelheim Investigational Site
Bucharest
1220.40.4002 Boehringer Ingelheim Investigational Site
Bucharest
1220.40.4003 Boehringer Ingelheim Investigational Site
Bucharest
Austria2 sites
1220.40.4303 Boehringer Ingelheim Investigational Site
Linz
1220.40.4301 Boehringer Ingelheim Investigational Site
Vienna
About this study
Official title: Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1
- Conditions
- Hepatitis C
- Being tested
- BI 201335, Pegylated Interferon-alpha (IFN), Ribavirin (RBV)
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 201335Drug
BI 201335
BI 201335Drug
BI 201335
Pegylated Interferon-alpha (IFN)Drug
Pegylated Interferon-alpha
Ribavirin (RBV)Drug
Ribavirin (RBV)
| Study group | Role | What they receive |
|---|---|---|
| short arm | Experimental | patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV) Receives: Drug: BI 201335; Drug: Pegylated Interferon-alpha (IFN); Drug: Ribavirin (RBV) |
| long arm | Experimental | patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV) Receives: Drug: BI 201335; Drug: Pegylated Interferon-alpha (IFN); Drug: Ribavirin (RBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological Response at Week 28 (W28VR)
Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.
Measured: 28 weeks
Secondary outcomes (15)
Rapid Virological Response at Week 4 (RVR)
Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.
Measured: 4 weeks
Virological Response at Week 24 (W24VR)
virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.
Measured: 24 weeks
Virological Response at Week 36 (W36VR)
Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.
Measured: 36 weeks
End of Treatment Response (ETR)
End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.
Measured: up to 48 weeks
Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy
Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.
Measured: 72 weeks
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up
Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.
Measured: From baseline to 72 weeks
Time to Reach a Plasma HCV RNA Level BLD While on Treatment
Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment
Measured: 48 weeks
Laboratory Test Abnormalities and Study Medication Tolerabilities
Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.
Measured: 48 weeks
Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination
No number of participants with clinically relevant abnormalities in vital signs and physical examination.
Measured: 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)
Change from baseline (CFB) in Red blood cells.
Measured: baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)
Change from baseline (CFB) in haematocrit and Eosinophils.
Measured: baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)
Change from baseline (CFB) in Platelets and white blood cells.
Measured: baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)
Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.
Measured: baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)
Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.
Measured: baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)
Change from baseline (CFB) in PT-INR (ratio).
Measured: baseline and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionApr 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 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
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984620
- Sponsor's protocol ID
- 1220.40
- Other IDs
- 2009-012579-90, 2009
- Status last verified
- Aug 2015
- First submitted
- 24 Sep 2009
- Last updated
- 7 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Dieterich D, Asselah T, Guyader D, Berg T, Schuchmann M, Mauss S, Ratziu V, Ferenci P, Larrey D, Maieron A, Stern JO, Ozan M, Datsenko Y, Bocher WO, Steinmann G. SILEN-C3, a phase 2 randomized trial with faldaprevir plus pegylated interferon alpha-2a and ribavirin in treatment-naive hepatitis C virus genotype 1-infected patients. Antimicrob Agents Chemother. 2014 Jun;58(6):3429-36. doi: 10.1128/AAC.02497-13. Epub 2014 Apr 7.
PubMed 24709256
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)
- ClinicalTrials.gov ID
- NCT00984620
- Acronym / sponsor ID
- 1220.40
- Conditions
- Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Posted 7 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short arm | Experimental | Drug: BI 201335, Drug: Pegylated Interferon-alpha (IFN), Drug: Ribavirin (RBV)patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV) |
| long arm | Experimental | Drug: BI 201335, Drug: Pegylated Interferon-alpha (IFN), Drug: Ribavirin (RBV)patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic hepatitis C infection of genotype 1
- Therapy-naïve to interferon, pegylated interferon, and ribavirin
- HCV viral load > 100.000 IU/ml at screening
- Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis
- Normal retinal finding on fundoscopy within 6 months prior to Day 1
Key exclusion criteria (13 listed)
- HCV of mixed genotype (1/2, 1/3, and 1/4) .
- Patients who have been previously treated with at least one dose of any protease inhibitor
- Evidence of liver disease due to causes other than chronic HCV infection
- Positive for HIV-1 or HIV-2 antibodies
- Hepatitis B virus (HBV) infection
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 201335BI 201335 | Drug | long arm |
| BI 201335BI 201335 | Drug | short arm |
| Pegylated Interferon-alpha (IFN)Pegylated Interferon-alpha | Drug | long arm, short arm |
| Ribavirin (RBV)Ribavirin (RBV) | Drug | long arm, short arm |
Primary outcome
Virological Response at Week 28 (W28VR)
Time frame: 28 weeks
Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.
15 secondary outcomes
Rapid Virological Response at Week 4 (RVR)
Time frame: 4 weeks
Virological Response at Week 24 (W24VR)
Time frame: 24 weeks
Virological Response at Week 36 (W36VR)
Time frame: 36 weeks
End of Treatment Response (ETR)
Time frame: up to 48 weeks
Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy
Time frame: 72 weeks
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up
Time frame: From baseline to 72 weeks
Time to Reach a Plasma HCV RNA Level BLD While on Treatment
Time frame: 48 weeks
Laboratory Test Abnormalities and Study Medication Tolerabilities
Time frame: 48 weeks
Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination
Time frame: 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)
Time frame: baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)
Time frame: baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)
Time frame: baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)
Time frame: baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)
Time frame: baseline and 48 weeks
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)
Time frame: baseline and 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24709256Dieterich D, Asselah T, Guyader D, Berg T, Schuchmann M, Mauss S, Ratziu V, Ferenci P, Larrey D, Maieron A, Stern JO, Ozan M, Datsenko Y, Bocher WO, Steinmann G. SILEN-C3, a phase 2 randomized trial with faldaprevir plus pegylated interferon alpha-2a and ribavirin in treatment-naive hepatitis C virus genotype 1-infected patients. Antimicrob Agents Chemother. 2014 Jun;58(6):3429-36. doi: 10.1128/AAC.02497-13. Epub 2014 Apr 7.
- 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
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 201335, Pegylated Interferon-alpha (IFN) and Ribavirin (RBV) in people with Hepatitis C, run by Boehringer Ingelheim at 28 sites in 6 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 6 inclusion and 13 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 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, France, Germany, Canada, Romania and 1 more country. 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 7 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?
Virological Response at Week 28 (W28VR) (time frame: 28 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 NCT00984620, 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 7 Sep 2015.