Open label trial to compare BI 207127 to Telaprevir in HCV patients

Phase 1

Conditions: Hepatitis C
MedDRA version: 15.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2012-004544-30-ES

Lead Sponsor: Boehringer Ingelheim españa, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 299997

Inclusion Criteria

1. Chronic HCV, diagnosed by HCV RNA ? 1,000 IU/mL 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 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:
a. no prior treatment with any interferon, pegylated interferon, and /or ribavirin

and

b. 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

a. with documented hysterectomy, or

b. who have had both ovaries removed, or

c. with documented tubal ligation, or

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 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

a. who are documented to be sterile, or

b. 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

c. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:

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) (cf. Appendix 10.2)
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 th

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to determine if BI207127 + Faldaprevir + Ribavirin for 24 weeks is non-inferior to treatment with telaprevir for 12 weeks + Ribavirin and Pegylated interferon for 24 or 48 weeks.;<br> Secondary Objective: ? To descriptively summarise the secondary efficacy endpoints,<br> ? To descriptively present SVR12 rates by important subgroups,<br> ? To descriptively summarise the other safety data.<br> ;Primary end point(s): Sustained Virological Response at Week 12 post-treatment (SVR12): Plasma HCV RNA level <25 IU/mL at 12 weeks after End Of Treatment.;Timepoint(s) of evaluation of this end point: This will be 12 weeks after the end of treatment which is Week 36 for treatment group 1 or week 36 or week 60 for patients in treatment group 2.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): ? SVR4: Plasma HCV RNA level <25 IU/mL at 4 weeks after End Of Treatment.<br><br> ? SVR24: Plasma HCV RNA level <25 IU/mL at 24 weeks after End Of Treatment.<br> ;<br> Timepoint(s) of evaluation of this end point: SVR4: 4 weeks after end of treatment, which is week 28 for patients in treatment group 1 and week 52 for patients in treatment group 2.<br><br> SVR24: 24 weeks after end of treatment, which is week 48 for patients in treatment group 1 and week 72 for patients in treatment group 2.<br>

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