Hepatitis C, ChronicPhase 3NCT01608737
A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection
A Phase 3 study testing PegIFN/RBV and BI 201335 in people with Hepatitis C, Chronic, run by Boehringer Ingelheim.
Trial summary
The objectives of this study are: 1. To evaluate the efficacy and safety of two different treatment regimens with BI 201335 (high dose given for 12 weeks or low dose given for 24 weeks both in combination with Pegylated interferon-a and Ribavirin (PegIFN/RBV) as compared to PegIFN/RBV alone in treatment-naïve (TN)… 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 and BI 201335
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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, diagnosed by positive anti-HCV antibodies and detectable hepatitis C virus (HCV) ribonucleic acid ( RNA) at screening in addition to:
- Positive anti-HCV antibodies or detectable HCV RNA at least 6 months prior to screening or,
- Liver biopsy consistent with chronic HCV infection
- HCV genotype 1 infection confirmed by genotypic testing at screening
- Therapy-naïve to interferon, pegylated interferon, and ribavirin (cohort 1). Or Confirmed prior relapse with an approved dose of PegIFN/RBV(Cohort 2) defined as undetectable HCV RNA (based on an assay considered sensitive at the time of treatment) at the end of treatment with a pegylated interferon-based regimen, but HCV RNA detectable within 24 weeks of treatment follow up
- HCV RNA =1,000 IU/mL at screening
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- Documentation of a liver biopsy within 3 years or fibroscan within 6 months prior to randomisation
- Age 18 to 70 years
- Female patients:
- with documented hysterectomy,
- who have had both ovaries removed,
- with documented tubal ligation,
- who are post-menopausal with last menstrual period at least 12 months prior to screening, or
- of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin
- Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, and intra uterine device.
- Male patients:
- who are documented to be sterile, or
- who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. Female partners of childbearing potential should perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor)
- Signed informed consent form prior to trial participation
Who cannot join
- HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
- Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criterion
- HIV co-infection
- Hepatitis B virus (HBV) infection based on presence of hepatitis B surface Antigen (HBs-Ag)
- Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
- Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
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- A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient's ability to participate in this study
- Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study
- Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to randomisation.Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened
- Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to randomisation and throughout the treatment phase
- Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors
- Known hypersensitivity to any ingredient of the study drugs
- Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI)) within last 6 months prior to randomisation (Visit 2) Other exclusion criteria related to pegylated interferon-a and/or ribavirin restrictions are not listed here.
About this study
Official title: A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 for 12 or 24 Weeks in Combination With Pegylated interferon-a and Ribavirin in Treatment-naive and Prior Relapser Patients With Genotype 1 Chronic Hepatitis C Infection
The objectives of this study are:
- To evaluate the efficacy and safety of two different treatment regimens with BI 201335 (high dose given for 12 weeks or low dose given for 24 weeks both in combination with Pegylated interferon-a and Ribavirin (PegIFN/RBV) as compared to PegIFN/RBV alone in treatment-naïve (TN) chronic genotype 1 hepatitis C virus infected patients.
- Evaluate the efficacy and the safety of BI 201335 high dose given for 12 weeks in combination with PegIFN/RBV given for 24 to 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected relapser patients who failed a prior PegIFN/RBV treatment.
- Conditions
- Hepatitis C, Chronic
- Being tested
- PegIFN/RBV, 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 48 weeks
BI 201335Drug
BI 201335 once daily high dose for 12 weeks
BI 201335Drug
BI 201335 once daily high dose for 12 weeks
PegIFN/RBVDrug
PegIFN/RBV for 48 weeks
BI 201335Drug
BI 201335 once daily low dose for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2. BI 201335 for 24 weeks | Experimental | BI 201335 once daily low dose for 24 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients Receives: Drug: BI 201335 |
| 3. BI 201335 for 12 weeks | Experimental | BI 201335 once daily high dose for 12 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients Receives: Drug: BI 201335 |
| 1. PegIFN/RBV | Active comparator | PegIFN/RBV for 48 weeks in treatment-naive patients Receives: Drug: PegIFN/RBV |
| 4. PegIFN/RBV | Active comparator | PegIFN/RBV for 48 weeks in prior relapser patients Receives: Drug: PegIFN/RBV |
| 5. BI 201335 for 12 weeks | Experimental | BI 201335 once daily high dose for 12 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in prior relapser patients Receives: Drug: BI 201335 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virological Response 12 weeks post-treatment (SVR12): Plasma Hepatitis C Virus (HCV) Ribonucleic Acid ( RNA) <25 IU/mL undetected at 12 weeks after the originally planned treatment duration.
Measured: 60 weeks
Secondary outcomes (3)
Virological response after 24 weeks of treatment discontinuation (SVR24): Plasma HCV RNA level <25 IU/mL, undetected; 24 weeks after the originally planned treatment duration
Measured: 72 weeks
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: 8 weeks
Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) normalisation. ALT and AST normal at end of treatment and post treatment.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Enrolment
- 0 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
- NCT01608737
- Sponsor's protocol ID
- 1220.8
- Other IDs
- 2012-001242-18
- Status last verified
- Feb 2013
- First submitted
- 29 May 2012
- Last updated
- 26 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 for 12 or 24 Weeks in Combination With Pegylated interferon-a and Ribavirin in Treatment-naive and Prior Relapser Patients With Genotype 1 Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT01608737
- Acronym / sponsor ID
- 1220.8
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2015 (estimated)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are:
- To evaluate the efficacy and safety of two different treatment regimens with BI 201335 (high dose given for 12 weeks or low dose given for 24 weeks both in combination with Pegylated interferon-a and Ribavirin (PegIFN/RBV) as compared to PegIFN/RBV alone in treatment-naïve (TN) chronic genotype 1 hepatitis C virus infected patients.
- Evaluate the efficacy and the safety of BI 201335 high dose given for 12 weeks in combination with PegIFN/RBV given for 24 to 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected relapser patients who failed a prior PegIFN/RBV treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2. BI 201335 for 24 weeks | Experimental | Drug: BI 201335BI 201335 once daily low dose for 24 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients |
| 3. BI 201335 for 12 weeks | Experimental | Drug: BI 201335BI 201335 once daily high dose for 12 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients |
| 1. PegIFN/RBV | Active comparator | Drug: PegIFN/RBVPegIFN/RBV for 48 weeks in treatment-naive patients |
| 4. PegIFN/RBV | Active comparator | Drug: PegIFN/RBVPegIFN/RBV for 48 weeks in prior relapser patients |
| 5. BI 201335 for 12 weeks | Experimental | Drug: BI 201335BI 201335 once daily high dose for 12 weeks, in combined with PegIFN/RBV for 24 or 48 weeks in prior relapser patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detectable hepatitis C virus (HCV) ribonucleic acid ( RNA) at screening in addition to:
- HCV genotype 1 infection confirmed by genotypic testing at screening
- Therapy-naïve to interferon, pegylated interferon, and ribavirin (cohort 1). Or Confirmed prior relapse with an approved dose of PegIFN/RBV(Cohort 2) defined as undetectable HCV RNA (based on an assay considered sensitive at the time of treatment) at the end of treatment with a pegylated interferon-based regimen, but HCV RNA detectable within 24 weeks of treatment follow up
- HCV RNA =1,000 IU/mL at screening
- Documentation of a liver biopsy within 3 years or fibroscan within 6 months prior to randomisation
Key exclusion criteria (13 listed)
- HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
- Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criterion
- HIV co-infection
- Hepatitis B virus (HBV) infection based on presence of hepatitis B surface Antigen (HBs-Ag)
- Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
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 48 weeks | Drug | 4. PegIFN/RBV |
| BI 201335BI 201335 once daily high dose for 12 weeks | Drug | 3. BI 201335 for 12 weeks |
| BI 201335BI 201335 once daily high dose for 12 weeks | Drug | 5. BI 201335 for 12 weeks |
| PegIFN/RBVPegIFN/RBV for 48 weeks | Drug | 1. PegIFN/RBV |
| BI 201335BI 201335 once daily low dose for 24 weeks | Drug | 2. BI 201335 for 24 weeks |
Primary outcome
Sustained Virological Response 12 weeks post-treatment (SVR12): Plasma Hepatitis C Virus (HCV) Ribonucleic Acid ( RNA) <25 IU/mL undetected at 12 weeks after the originally planned treatment duration.
Time frame: 60 weeks
3 secondary outcomes
Virological response after 24 weeks of treatment discontinuation (SVR24): Plasma HCV RNA level <25 IU/mL, undetected; 24 weeks after the originally planned treatment duration
Time frame: 72 weeks
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
Time frame: 8 weeks
Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) normalisation. ALT and AST normal at end of treatment and post treatment.
Time frame: 72 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PegIFN/RBV and BI 201335 in people with Hepatitis C, Chronic, run by Boehringer Ingelheim.
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 19 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: withdrawn, as of the sponsor's last update on 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 12 weeks post-treatment (SVR12): Plasma Hepatitis C Virus (HCV) Ribonucleic Acid ( RNA) <25 IU/mL undetected at 12 weeks after the originally planned treatment duration. (time frame: 60 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2013.