Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients
NCT ID: NCT01858961
Last Updated: 2014-01-23
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE3
Study Classification
INTERVENTIONAL
Study Start Date
2013-05-31
Study Completion Date
2016-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Hepatitis C, Chronic
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Group 1
BI 201335 in combination with BI 207127 and ribavirin for 24 weeks
Group Type
EXPERIMENTAL
BI 201335
Intervention Type
DRUG
Once a day
ribavirin
Intervention Type
DRUG
Twice a day
BI 207127
Intervention Type
DRUG
Twice a day
Group 2
Telaprevir in combination with PegIFN and ribavirin for 24 weeks or 48 weeks
Group Type
EXPERIMENTAL
Telaprevir
Intervention Type
DRUG
Three times a day
ribavirin
Intervention Type
DRUG
Twice a day
Pegylated Interferon
Intervention Type
DRUG
Once a week
Interventions
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BI 201335
Once a day
Intervention Type
DRUG
ribavirin
Twice a day
Intervention Type
DRUG
BI 207127
Twice a day
Intervention Type
DRUG
Telaprevir
Three times a day
Intervention Type
DRUG
ribavirin
Twice a day
Intervention Type
DRUG
Pegylated Interferon
Once a week
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Chronic HCV, diagnosed by HCV RNA = 1,000 IU/mL at screening in addition to at least one of the following:
1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening, OR
2. liver biopsy indicating chronic HCV infection, OR
3. history of elevated ALT levels at least 6 months prior to screening.
2. HCV infection of sub-GT1b confirmed by genotypic testing at screening.
3. Treatment naïve defined as:
1. no prior treatment with any interferon, pegylated interferon, and /or ribavirin and
2. no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection.
4. 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.
5. Age 18 - 70 years (inclusive).
6. Female patients
1. with documented hysterectomy, or
2. who have had both ovaries removed, or
3. with documented tubal ligation, or
4. who are post-menopausal with last menstrual period at least 12 months prior to screening, or
5. 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
1. who are documented to be sterile, or
2. 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
3. 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).
7. Signed informed consent form prior to trial participation.
1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening, OR
2. liver biopsy indicating chronic HCV infection, OR
3. history of elevated ALT levels at least 6 months prior to screening.
2. HCV infection of sub-GT1b confirmed by genotypic testing at screening.
3. Treatment naïve defined as:
1. no prior treatment with any interferon, pegylated interferon, and /or ribavirin and
2. no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection.
4. 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.
5. Age 18 - 70 years (inclusive).
6. Female patients
1. with documented hysterectomy, or
2. who have had both ovaries removed, or
3. with documented tubal ligation, or
4. who are post-menopausal with last menstrual period at least 12 months prior to screening, or
5. 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
1. who are documented to be sterile, or
2. 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
3. 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).
7. Signed informed consent form prior to trial participation.
Exclusion Criteria
1. HCV infection of mixed genotype (1/2, 1/3, and 1/4), HCV sub-GT1a or GT1 undefined, diagnosed at screening by genotypic testing.
2. 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.
3. HIV infection.
4. Hepatitis B virus (HBV) infection based on presence of Hepatitis B surface antigen.
5. 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)
6. 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).
7. Patients with ongoing or historical photosensitivity or recurrent rash.
8. History of illicit drug use (other than cannabis) or chronic alcohol abuse within 12 months prior to randomization, in the opinion of the Investigator.
9. Body mass index \<18 or \>35 kg/m2.
10. 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.
11. Known hypersensitivity to any ingredient of the study drugs.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. Abnormal thyroid function that cannot be controlled effectively by medication.
18. Active autoimmune-mediated disease (e.g., Crohn's disease, ulcerative colitis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis).
19. Requirement for chronic systemic corticosteroids (inhaled or nasally administered or pulmonary steroids will be allowed).
20. History or other evidence of severe retinopathy or clinically significant ophthalmological disorder due to diabetes mellitus or hypertension (but not limited to these conditions).
2. 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.
3. HIV infection.
4. Hepatitis B virus (HBV) infection based on presence of Hepatitis B surface antigen.
5. 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)
6. 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).
7. Patients with ongoing or historical photosensitivity or recurrent rash.
8. History of illicit drug use (other than cannabis) or chronic alcohol abuse within 12 months prior to randomization, in the opinion of the Investigator.
9. Body mass index \<18 or \>35 kg/m2.
10. 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.
11. Known hypersensitivity to any ingredient of the study drugs.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. Abnormal thyroid function that cannot be controlled effectively by medication.
18. Active autoimmune-mediated disease (e.g., Crohn's disease, ulcerative colitis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis).
19. Requirement for chronic systemic corticosteroids (inhaled or nasally administered or pulmonary steroids will be allowed).
20. History or other evidence of severe retinopathy or clinically significant ophthalmological disorder due to diabetes mellitus or hypertension (but not limited to these conditions).
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1241.37.61002 Boehringer Ingelheim Investigational Site
Westmead, New South Wales, Australia
Site Status
1241.37.61001 Boehringer Ingelheim Investigational Site
Adelaide, South Australia, Australia
Site Status
1241.37.61003 Boehringer Ingelheim Investigational Site
Fitzroy, Victoria, Australia
Site Status
1241.37.34010 Boehringer Ingelheim Investigational Site
Alzira, , Spain
Site Status
1241.37.34005 Boehringer Ingelheim Investigational Site
Barcelona, , Spain
Site Status
1241.37.34002 Boehringer Ingelheim Investigational Site
L'Hospitalet Llobregat (bcn), , Spain
Site Status
1241.37.34001 Boehringer Ingelheim Investigational Site
Madrid, , Spain
Site Status
1241.37.34003 Boehringer Ingelheim Investigational Site
Madrid, , Spain
Site Status
1241.37.34004 Boehringer Ingelheim Investigational Site
Madrid, , Spain
Site Status
1241.37.34006 Boehringer Ingelheim Investigational Site
Valencia, , Spain
Site Status
1241.37.46002 Boehringer Ingelheim Investigational Site
Lund, , Sweden
Site Status
1241.37.46001 Boehringer Ingelheim Investigational Site
Stockholm, , Sweden
Site Status
Countries
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Australia
Spain
Sweden
Other Identifiers
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2012-004544-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1241.37
Identifier Type: -
Identifier Source: org_study_id
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