A clinical trial for testing efficacy and safety of BI 207127 in combination with Faldaprevir and Ribavirin in patients with Chronic Genotype 1 HCV Infection who received no previous medication, incl. patients that cannot receive peginterfero

• Conditions: MedDRA version: 15.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-003535-27-ES
• Lead Sponsor: Boehringer Ingelheim España, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-26
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 590

Inclusion Criteria

1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to at least one of the following:
a. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening, or
b. liver biopsy indicating chronic HCV infection, or
c. history of elevated alanine aminotransferase (ALT) levels at least 6 months prior to screening.
2. HCV infection of:
a. sub-GT1b confirmed by genotypic testing at screening; or,
b. sub-GT1a, GT1(with undefined subtype), or mixed sub-GT1a/1b confirmed by genotypic testing at screening in patients with IL-28b CC genotype.
3. HCV viral load ? 1,000 IU/mL at randomisation.
4. Patients who have never been previously treated with interferon alone, interferon+RBV, PegIFN+RBV or PegIFN+RBV+an investigational/approved DAA or any other HCV treatment regimen.
5. Results of the IL-28b genotyping (rs12979860 polymorphism) at randomisation.
6. Availability of a liver biopsy within 3 years or fibroscan within 6 months prior to randomisation.
7. Age 18 to 75 years (inclusive).
8. Female patients:
a. with documented hysterectomy,
b. who have had both ovaries removed,
c. with documented tubal ligation,
d. who are post-menopausal with last menstrual period at least 12 months prior to screening, or
e. of childbearing potential with a negative serum pregnancy test at screening and Day 1, who, if sexually active, agree to use two non-hormonal methods of birth control from the date of screening until 7 months after the last dose of RBV. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of RBV. Accepted methods of contraception in the study include diaphragm with spermicidal substance, cervical caps, intrauterine devices 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:
a. who are documented to be sterile, or
b. 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 RBV. 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 RBV (tests will be provided by the sponsor).
9. Signed informed consent form prior to trial participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
2. HCV infection of sub-GT1a in patients with IL-28b CT or TT (non-CC polymorphisms).
3. 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 diseases. Note: patients with steatosis as part of the histological findings of the liver biopsy are not excluded.
4. HIV infection.
5. Hepatitis B virus (HBV) infection based on presence of HBs-Ag.
6. Confirmed or suspected 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).
7. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
8. Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).
9. 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, including but not limited to severe chronic obstructive pulmonary disease, uncontrolled psychiatric disease.
10. Decompensated liver disease, or history of decompensated liver disease, as evidenced by ascites, hepatic encephalopathy, history of esophageal variceal bleeding, or any other evidence of previous decompensation.
11. Total bilirubin >2 mg/dL with ratio of direct/indirect >1.
12. Serum albumin ?3.5 g/dL.
13. Prothrombin time Institutional Normalised Ratio (INR) ?1.7.
14. Clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia, including unstable angina, recent myocardial infarction, cardiomyopathy, congestive heart failure, uncontrolled hypertension or significant arrhythmia.
15. Red blood cell (RBC) disorders which include but are not limited to: thalassemia major, sickle cell anemia or G6PD deficit. Patients with traits or minor diseases (e.g. sickle cell trait or thalassemia minor) may be enrolled if the disease did not result in anemia at screening, according to the investigator?s clinical judgment.
16. Body weight <40 kg or >125 kg.
17. Usage of any investigational drugs within 28 days prior to randomisation, or planned usage of an investigational drug during the course of this study.
18. Received concomitant hematopoietic growth factor within 28 days prior to enrolment.
19. Received silymarin (milk thistle), glycyrrhizin, Sho-saiko-to (SST) 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.
20. Known hypersensitivity to any ingredient of the study drugs.
21. 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, computer tomography (CT) scan, or Medical Resonance Imaging (MRI)) within last 6 months prior to randomization.
22. Haemoglobin <11 g/dL for women and <12 g/dL for men.
23. Absolute neutrophil count <1,000 cells/mm3.
24. Platelet count <70,000 cells/mm3.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified