Hepatitis C, ChronicPhase 3NCT01858961
Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients
A Phase 3 study testing BI 201335, ribavirin and BI 207127 in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 12 sites in 3 countries.
Trial summary
The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis. 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 201335, ribavirin and BI 207127
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 12 sitesin 3 countries
- Study dates
- May 2013to Jul 2016
- 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 HCV, diagnosed by HCV RNA = 1,000 IU/mL at screening in addition to at least one of the following:
- positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening, OR
- liver biopsy indicating chronic HCV infection, OR
- history of elevated ALT levels at least 6 months prior to screening.
- HCV infection of sub-GT1b confirmed by genotypic testing at screening.
- Treatment naïve defined as:
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- no prior treatment with any interferon, pegylated interferon, and /or ribavirin and
- no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection.
- Availability of a liver biopsy within three years or fibroscan within 6 months prior to randomisation.
- Note: patients who do not have a liver biopsy (nor fibroscan) due to contraindication of the procedure should not be excluded for this reason. The decision on the inclusion of these patients should be discussed with the CML. Patients with a liver biopsy performed 3 or more years (or fibroscan performed 6 months or more) prior to randomisation, demonstrating cirrhosis do not need to repeat a liver biopsy or fibroscan.
- Age 18 - 70 years (inclusive).
- Female patients
- with documented hysterectomy, or
- who have had both ovaries removed, or
- with documented tubal ligation, or
- 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 on Day 1 (Visit 2), who agree to use two non-hormonal methods of birth control from the date of screening until 7 months after the last dose of ribavirin. They must not breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin.
- Accepted methods of contraception for females in this trial are diaphragm with spermicide substances, intrauterine devices, cervical caps and condoms.
- Note: Systemic hormonal contraceptives may not be as effective in women taking BI 207127/FDV combination therapy and are not accepted methods of contraception in the study.
- OR:
- Male patients
- who are documented to be sterile, or
- who consistently and correctly use a condom while their female partners (if of child-bearing potential) 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, and
- without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and follow-up phase. Female partners of childbearing potential must 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), HCV sub-GT1a or GT1 undefined, diagnosed at screening by genotypic testing.
- Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver disease.
- HIV infection.
- Hepatitis B virus (HBV) infection based on presence of Hepatitis B surface antigen.
- Evidence of decompensated liver disease or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, bleeding esophageal varices or any other evidence of previous decompensation and/or any laboratory results (International Normalised Ratio, albumin, bilirubin) indicating a Child-Pugh-Turcotte score > 6 points (i.e. CPT-B or -C)
- Confirmed or suspected active malignancy or history of malignancy within the last 5 years (with the exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
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- Patients with ongoing or historical photosensitivity or recurrent rash.
- History of illicit drug use (other than cannabis) or chronic alcohol abuse within 12 months prior to randomization, in the opinion of the Investigator.
- Body mass index <18 or >35 kg/m2.
- Usage of any investigational drugs within 28 days prior to randomisation, or the planned usage of an investigational drug during the course of the current study.
- Known hypersensitivity to any ingredient of the study drugs.
- A condition that is insufficiently diagnosed, treated or clinically unstable which in the opinion of Investigator may put the patient at risk because of participation in this study, influence the results of this study, or limit the patient's ability to participate in this study.
- Alpha fetoprotein value >100ng/mL at screening; if > 20ng/mL and = 100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation.
- A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease (e.g. congestive heart failure, myocardial infarction, unstable angina and arrhythmic disorders) current or within the previous 12 months before randomisation. Clinically significant Electrocardiogram (ECG) abnormalities. A history of congenital QT prolongation, or a family history of congenital QT prolongation or sudden death.
- Received silymarin (milk thistle) or glycyrrhizin or Sho-saiko-to (SST) within 28 days prior to randomisation or any medication listed in a restricted medication list provided in ISF within 28 days prior to randomisation, with the exception of parenteral analgesics used during liver biopsy procedure.
- Pre-existing psychiatric conditions that could interfere with the subject's participation in and completion of the study including but not limited to severe depression or hospitalization for depression, suicidal ideation and attempted suicide, schizophrenia, bipolar illness, severe anxiety or personality disorder, history of craniocerebral trauma or active seizure disorders requiring medication, a period of disability or impairment due to a psychiatric disease current or within the previous 3 years before randomisation.
- Abnormal thyroid function that cannot be controlled effectively by medication.
- Active autoimmune-mediated disease (e.g., Crohn's disease, ulcerative colitis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis).
- Requirement for chronic systemic corticosteroids (inhaled or nasally administered or pulmonary steroids will be allowed).
- History or other evidence of severe retinopathy or clinically significant ophthalmological disorder due to diabetes mellitus or hypertension (but not limited to these conditions).
- Plus other exclusion criteria relating to Peg interferon, ribavirin and Telaprevir.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Spain7 sites
1241.37.34010 Boehringer Ingelheim Investigational Site
Alzira
1241.37.34005 Boehringer Ingelheim Investigational Site
Barcelona
1241.37.34002 Boehringer Ingelheim Investigational Site
L'Hospitalet Llobregat (bcn)
1241.37.34001 Boehringer Ingelheim Investigational Site
Madrid
1241.37.34003 Boehringer Ingelheim Investigational Site
Madrid
1241.37.34004 Boehringer Ingelheim Investigational Site
Madrid
1241.37.34006 Boehringer Ingelheim Investigational Site
Valencia
Australia3 sites
1241.37.61001 Boehringer Ingelheim Investigational Site
Adelaide, South Australia
1241.37.61003 Boehringer Ingelheim Investigational Site
Fitzroy, Victoria
1241.37.61002 Boehringer Ingelheim Investigational Site
Westmead, New South Wales
Sweden2 sites
1241.37.46002 Boehringer Ingelheim Investigational Site
Lund
1241.37.46001 Boehringer Ingelheim Investigational Site
Stockholm
About this study
Official title: A Phase III, Randomised, Open Label, Active-controlled Study of an Interferon-free Regimen of BI 207127 in Combination With Faldaprevir and Ribavirin Compared to Telaprevir in Combination With Pegylated interferon-a and Ribavirin in Treatment-naive Patients With Chronic Genotype 1b Hepatitis C Virus Infection
The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis.
- Conditions
- Hepatitis C, Chronic
- Being tested
- BI 201335, ribavirin, BI 207127, Telaprevir, Pegylated Interferon
- 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 201335Drug
Once a day
ribavirinDrug
Twice a day
BI 207127Drug
Twice a day
TelaprevirDrug
Three times a day
ribavirinDrug
Twice a day
Pegylated InterferonDrug
Once a week
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | BI 201335 in combination with BI 207127 and ribavirin for 24 weeks Receives: Drug: BI 201335; Drug: ribavirin; Drug: BI 207127 |
| Group 2 | Experimental | Telaprevir in combination with PegIFN and ribavirin for 24 weeks or 48 weeks Receives: Drug: Telaprevir; Drug: ribavirin; Drug: Pegylated Interferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response at Week 12 after end of treatment (SVR12)
Measured: at week 12 post treatment
Secondary outcomes (19)
SVR4: Plasma HCV RNA level <25 IU/mL1 at 4 weeks after end of treatment
Measured: at week 4 post treatment
SVR24: Plasma HCV RNA level <25 IU/mL1 at 24 weeks after end of treatment
Measured: at week 4 post treatment
Virological Response at Week 4 -Plasma HCV RNA level undetectable at Week 4 -Plasma HCV RNA level <25 IU/mL at Week 4
Measured: at week 4 post treatment
Plasma HCV level undetectable at Week 12
Measured: at week 12
Time to achieving HCV RNA undetectable
Measured: up to week 48
Virological breakthrough
Measured: up to week 48
ETR: Plasma HCV RNA level undetected at the end of treatment
Measured: week 24 or 48
Lack of on-treatment viral response
Measured: up to week 48
Relapse
Measured: up to 48 weeks post treatment
Adverse events
Measured: up to week 48 post treatment
Adverse events leading to discontinuation
Measured: up to week 48
Serious Adverse Events
Measured: up to week 48 post treatment
Laboratory test abnormalities by DAIDS grades
Measured: up to week 48 post treatment
Rate of red blood cell transfusion
Measured: up to week 48 post treatment
Time to discontinuation of trial medication
Measured: up to week 48
Liver disease progression, fibroscan and FibroSURE
Measured: up to week 48 post treatment
Rate of ESA use
Measured: up to week 48 post treatment
Change in laboratory test values over time
Measured: up to week 48 post treatment
Patients requiring hospitalisation due to AEs related to study drugs
Measured: up to week 48 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (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
- None (open label)
- 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
- NCT01858961
- Sponsor's protocol ID
- 1241.37
- Other IDs
- 2012-004544-30
- Status last verified
- Jan 2014
- First submitted
- 17 May 2013
- Last updated
- 23 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Open Label, Active-controlled Study of an Interferon-free Regimen of BI 207127 in Combination With Faldaprevir and Ribavirin Compared to Telaprevir in Combination With Pegylated interferon-a and Ribavirin in Treatment-naive Patients With Chronic Genotype 1b Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT01858961
- Acronym / sponsor ID
- 1241.37
- 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
- May 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 21 May 2013 (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 aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: BI 201335, Drug: ribavirin, Drug: BI 207127BI 201335 in combination with BI 207127 and ribavirin for 24 weeks |
| Group 2 | Experimental | Drug: Telaprevir, Drug: ribavirin, Drug: Pegylated InterferonTelaprevir in combination with PegIFN and ribavirin for 24 weeks or 48 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Chronic HCV, diagnosed by HCV RNA = 1,000 IU/mL at screening in addition to at least one of the following:
- HCV infection of sub-GT1b confirmed by genotypic testing at screening.
- Treatment naïve defined as:
- Availability of a liver biopsy within three years or fibroscan within 6 months prior to randomisation.
- Note: patients who do not have a liver biopsy (nor fibroscan) due to contraindication of the procedure should not be excluded for this reason. The decision on the inclusion of these patients should be discussed with the CML. Patients with a liver biopsy performed 3 or more years (or fibroscan performed 6 months or more) prior to randomisation, demonstrating cirrhosis do not need to repeat a liver biopsy or fibroscan.
Key exclusion criteria (21 listed)
- HCV infection of mixed genotype (1/2, 1/3, and 1/4), HCV sub-GT1a or GT1 undefined, diagnosed at screening by genotypic testing.
- Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver disease.
- HIV infection.
- Hepatitis B virus (HBV) infection based on presence of Hepatitis B surface antigen.
- Evidence of decompensated liver disease or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, bleeding esophageal varices or any other evidence of previous decompensation and/or any laboratory results (International Normalised Ratio, albumin, bilirubin) indicating a Child-Pugh-Turcotte score > 6 points (i.e. CPT-B or -C)
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 201335Once a day | Drug | Group 1 |
| ribavirinTwice a day | Drug | Group 1 |
| BI 207127Twice a day | Drug | Group 1 |
| TelaprevirThree times a day | Drug | Group 2 |
| ribavirinTwice a day | Drug | Group 2 |
| Pegylated InterferonOnce a week | Drug | Group 2 |
Primary outcome
Sustained Virologic Response at Week 12 after end of treatment (SVR12)
Time frame: at week 12 post treatment
19 secondary outcomes
SVR4: Plasma HCV RNA level <25 IU/mL1 at 4 weeks after end of treatment
Time frame: at week 4 post treatment
SVR24: Plasma HCV RNA level <25 IU/mL1 at 24 weeks after end of treatment
Time frame: at week 4 post treatment
Virological Response at Week 4 -Plasma HCV RNA level undetectable at Week 4 -Plasma HCV RNA level <25 IU/mL at Week 4
Time frame: at week 4 post treatment
Plasma HCV level undetectable at Week 12
Time frame: at week 12
Time to achieving HCV RNA undetectable
Time frame: up to week 48
Virological breakthrough
Time frame: up to week 48
ETR: Plasma HCV RNA level undetected at the end of treatment
Time frame: week 24 or 48
Lack of on-treatment viral response
Time frame: up to week 48
Relapse
Time frame: up to 48 weeks post treatment
Adverse events
Time frame: up to week 48 post treatment
Adverse events leading to discontinuation
Time frame: up to week 48
Serious Adverse Events
Time frame: up to week 48 post treatment
Laboratory test abnormalities by DAIDS grades
Time frame: up to week 48 post treatment
Rate of red blood cell transfusion
Time frame: up to week 48 post treatment
Time to discontinuation of trial medication
Time frame: up to week 48
Liver disease progression, fibroscan and FibroSURE
Time frame: up to week 48 post treatment
Rate of ESA use
Time frame: up to week 48 post treatment
Change in laboratory test values over time
Time frame: up to week 48 post treatment
Patients requiring hospitalisation due to AEs related to study drugs
Time frame: up to week 48 post treatment
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 23 Jan 2014.
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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
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BI 201335, ribavirin and BI 207127 in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 12 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 25 inclusion and 21 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 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, Australia, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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 Virologic Response at Week 12 after end of treatment (SVR12) (time frame: at week 12 post treatment). 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 23 Jan 2014.