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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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18 October 2021 |
Main ID: |
EUCTR2009-009608-38-FR |
Date of registration:
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08/09/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Randomized, Partially-blind Study to Evaluate the Safety, Tolerability and Effect on Virological Response of Treatment with the HCV Protease Inhibitor RO5190591 in combination with Pegasys and Copegus for 12 or 24 weeks, versus treatment with Pegasys and Copegus alone, in Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection
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Scientific title:
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A Randomized, Partially-blind Study to Evaluate the Safety, Tolerability and Effect on Virological Response of Treatment with the HCV Protease Inhibitor RO5190591 in combination with Pegasys and Copegus for 12 or 24 weeks, versus treatment with Pegasys and Copegus alone, in Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection |
Date of first enrolment:
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31/07/2009 |
Target sample size:
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300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-009608-38 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Partially Blind If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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France
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Germany
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Italy
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age 18 years and older 2. Serologic evidence of CHC infection by an anti-HCV antibody test (current or historical) 3. Evidence of chronic hepatitis C infection > 6 months duration 4. Evidence of hepatitis C genotype 1 infection by molecular assay 5. Serum HCV RNA quantifiable at = 50,000 IU/mL as demonstrated by the Roche COBAS TaqMan HCV Test 6. HCV treatment-naïve (i.e. have never received treatment for CHC, including but not limited to IFN-based therapy, ribavirin, or other anti-viral agents with established or perceived activity against the HCV virus) 7. Liver biopsy within the past 24 months showing clear absence of advanced fibrosis or cirrhosis (as indicated in Appendix 1). Liver biopsy should be scored using one of the scoring methods in Appendix 1. 8. Normal cardiac troponin I (cTnI) value at the screening visit (< 0.100 ng/mL) 9. Serum total bilirubin value at the screening visit within the reference range 10. Negative urine pregnancy test (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs confirmed by a negative serum pregnancy test collected within 24 hours prior to the first dose of study drug. Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and following the last dose of RBV in accordance with locally approved label for RBV 11. Willingness to give written informed consent and willingness to participate in and comply with the study requirements 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Infection with any HCV genotype other than genotype 1 or an indeterminate or mixed genotype. Genotype 1 pts w indeterminate or mixed subtypes will be allowed 2. History of having received any IMP = 3m prior to the 1st dose of study drug or the expectation that such drugs will be used during the study. Pts enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes Pts who are expected to need systemic antiviral therapy with established or perceived activity against HCV at any time during their participation in the study are also excl 4. + test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab 5. History or other evidence of a medical condition associated with chronic liver disease other than HCV 6. Females who are pregnant or breast feeding 7. Male partners of females who are pregnant 8. BMI < 18 or = 36 9. Absolute neutrophil count (ANC) < 1.5 x 103 / µL (< 1.5 x 109 /L) 10. Platelet count < 90 x 103 / µL (< 90 x 109 /L) 11. Hemoglobin (Hgb) concentration < 11 g/dL (< 110 g/L) in females or < 12 g/dL (<120 g/L)in males or any pt w a baseline increased risk for anemia or for whom anemia would be medically problematic 12. Serum creatinine level > 1.5* the upper limit of normal at screening 13. The use of colony stimulating factors such as granulocyte colony stimulating factor (G-CSF), erythropoietin, blood transfusion or other therapeutic agents to elevate hematology parameters to facilitate patient entry into the study within the last 6m 14. Hist of severe psychiatric disease, incl psychosis and/or severe depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease. In add, pts w a concurrent psychiatric condition or history of a psychiatric condition that, in the opinion of the Inv and/or Psychiatrist, would compromise participation in this study 15. Hist of immunologically mediated disease 17. Poorly controlled hypertension, with a hist of poor adherence to antihypertensive therapy or screening or baseline blood pressure of systolic = 160 mmHg and/or diastolic =100 mmHg 18. Type I or II diabetes with HbA1C > 8.5% at the Screening Visit 19. Hist or other evidence of chronic pulmonary disease associated with functional limitation 20. Hist of severe cardiac disease. In add, pts w doc or presumed coronary artery disease, stable or unstable cardiovascular disease or cerebrovascular disease should not be enrolled 21. Pts w higher potential for QTC prolongation; defined by QTC = 450 ms, or notable resting bradycardia < 50 beats/min, or notable resting tachycardia > 100 beats/min or personal or family history of congenital long QT syndrome or sudden death 22. Hist of uncontrolled severe seizure disorder 23. Evidence of an active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2y. 24. Hist of any systemic anti-neoplastic or immunomodulatory treatment (incl supraphysiologic doses of steroids and radiation) = 6m prior to the 1st dose of study drug or the expectation that such treatment will be needed at any time during the study 25. Poorly controlled thyroid dysfunction 26. Hist or other evidence of a clinically relevant ophthalmologic disorder due to diabetes mellitus or hypertension or history /other evidence of severe retinopathy 27. Hist of major organ transplantation with an existing functional graft 28. Hist or other evidence
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis C Genotype 1 Virus Infection (Treatment-Naïve Patients) MedDRA version: 9.1
Level: LLT
Classification code 10008912
Term: Chronic hepatitis C
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Intervention(s)
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Product Code: RO5190591/F02 (ITMN-191) Pharmaceutical Form: Capsule, soft Current Sponsor code: RO519-0591/F02 (ITMN-191) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use
Product Code: RO5190591/F10(ITMN-191) Pharmaceutical Form: Capsule, soft Current Sponsor code: RO519-0591/F10 (ITMN-191) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use
Trade Name: Pegasys Pharmaceutical Form: Solution for injection INN or Proposed INN: pegylated interfron alfa-2a CAS Number: 198153-51-4 Current Sponsor code: Ro 25-8310 Other descriptive name: pegylated interfron alfa-2a Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 180-
Trade Name: Copegus Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ribavirin CAS Number: 36791-04-5 Current Sponsor code: RO20-9963 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
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Primary Outcome(s)
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Primary end point(s): The primary measure of efficacy is SVR defined as the percentage of patients with undetectable HCV RNA as measured by the Roche COBAS TaqMan HCV Test (detection limit = 15 IU/mL) 24 weeks after end of treatment (SVR-24; a single last HCV RNA undetectable = 20 weeks after last dose). Patients without HCV RNA measurements at the end of the 24-week treatment-free follow-up period will be considered non-responders. This definition of SVR will be “SVR according to actual treatment period”.
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Main Objective: To evaluate the safety, tolerability, and effect on virologicalresponse of a 12 and 24-week duration of RO5190591 incombination with Pegasys and Copegus compared to thecombination of Pegasys and Copegus alone in treatment-naïvepatients with chronic hepatitis C genotype 1 virus infection
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Secondary Objective: To evaluate the pharmacokinetics of RO5190591 in combination with Pegasys and Copegus To evaluate the viral resistance profile of RO5190591 in combination with Pegasys and Copegus
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Secondary ID(s)
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2009-009608-38-DE
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NV21075
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 15/06/2009
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