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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. |
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Register:
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EUCTR |
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Last refreshed on:
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9 October 2012 |
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Main ID: |
EUCTR2005-005507-41-BE |
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Date of registration:
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24/10/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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Randomized, Multicenter, Double-Blinded, Phase IV Study Evaluating the Efficacy (as measured by Sustained Virological Response) and Safety of 360 µg Induction Dosing of Pegasys in Combination with Higher Copegus Doses in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater than or Equal to 85 kg - PROGRESS |
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Date of first enrolment:
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14/02/2007 |
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Target sample size:
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1140 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005507-41 |
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Study type:
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Interventional clinical trial of medicinal product |
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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: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Belgium
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Denmark
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France
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Germany
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Hungary
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Netherlands
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
To be eligible for this trial, patients must have documentation of the following:
• Age >=18 years
• Body weight >= 85 kg
• Serologic evidence of CHC infection by an anti-HCV antibody test (current or historical)
• Evidence of hepatitis C genotype 1 infection by molecular assay
• Serum HCV RNA quantifiable at >= 400,000 IU/mL by the Roche TaqMan HCV Test
• Chronic liver disease consistent with CHC infection on a biopsy obtained within the past 24 calendar months as judged by a central pathologist. For patients with incomplete/transition to cirrhosis or cirrhosis, a biopsy within 36 calendar months before the first dose is sufficient. A maximum of 20% of patients with cirrhosis or incomplete/transition to cirrhosis will be permitted to enroll in the trial.
• Patients with cirrhosis or incomplete/transition to cirrhosis must have an abdominal ultrasound, computerized tomographic (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma (within 2 months prior to randomization) and a serum alpha-fetoprotein (AFP) <100 ng/mL
• Compensated liver disease (Child-Pugh Grade A clinical classification only)
• Negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. 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 6 months after treatment end
• 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:
Patients with any of the following will not be eligible for participation:
• Infection with HCV genotype 1 mixed with a genotype other than genotype 2 or genotype 3 or infection with an indeterminate genotype. Patients with indeterminate or mixed genotype 1 subtypes will be allowed.
• History of having received interferon alpha (IFN), PEG-IFN, ribavirin, viramidine, levovirin, or investigational HCV protease or polymerase inhibitors at any previous time, or any other systemic antiviral therapy with established or perceived activity against the hepatitis C virus =<3 months prior to the first dose of study drug
• History of having received any investigational drug =< 3 months prior to the first dose of study drug or the expectation that such drugs will be used during the study. Patients enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes.
• Patients 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 excluded
• Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
• History or other evidence of a medical condition associated with chronic liver disease other than CHC (eg, hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• Females who are pregnant or breast-feeding
• Male partners of females who are pregnant
• Absolute neutrophil count (ANC) <1500 cells/mm3
• Platelet count <90,000 cells/mm3
• Hemoglobin concentration <12 g/dL in females or <13 g/dL in males or any patient with a baseline increased risk for anemia (eg, thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic
• Serum creatinine concentration >1.5 times the upper limit of normal at screening
• The use of colony stimulating factors such as granulocyte colony stimulating factor (G-CSF), erythropoetin or other therapeutic agents to elevate hematology arameters to facilitate patient entry into the study
• History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease
• Beck Depression Inventory (BDI) score of >= 20
• History of immunologically mediated disease (eg, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis (defined as affecting >10% of the body, here the palm of one hand equals 1%, or if the hands and feet are affected), rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management
• History or other evidence of decompensated liver disease or a Child-Pugh score >6.
Coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices are conditions consistent with decompensated liver disease
• History or other evidence of chronic pulmonary disease associated with functional limitation
• History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or ce
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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genotype 1 chronic hepatitis C infection of high viral titer and baseline body weight greater than or equal to 85 kg
MedDRA version: 8.1
Level: LLT
Classification code 10008912
Term: Chronic hepatitis C
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Intervention(s)
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Trade Name: Pegasys
Product Name: Pegasys 180 micrograms solution for injection
Product Code: RO 25-8310
Pharmaceutical Form: Solution for injection
Product Name: Pegasys 360 micrograms solution for injection
Product Code: RO 25-8310
Pharmaceutical Form: Solution for injection
INN or Proposed INN: peginterferon alfa-2a
CAS Number: 198153-51-4
Current Sponsor code: RO 25-8310
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 360-
Trade Name: Copegus
Product Name: Copegus 200 mg film-coated tablet
Product Code: RO 20-9963
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: To compare the efficacy and safety of 360 µg induction dosing of Pegasys for 12 weeks followed by a 180 µg maintenance dose of Pegasys for 36 weeks in combination with Copegus for 48 weeks with the efficacy and safety of 180 µg fixed dosing of Pegasys in combination with Copegus for 48 weeks in patients with genotype 1 chronic hepatitis C infection of high viral titer and baseline body weight equal to or greater than 85 kg
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Primary end point(s): Serum HCV RNA will be assessed by PCR techniques and monitored for efficacy.
Qualitative HCV RNA assessments and quantitative HCV RNA titers will be obtained throughout the treatment period and the 24-week follow-up period using the aqMan HCV Test according to the Schedule of Assessments.
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Secondary Objective: • To compare the efficacy and safety of higher dose Copegus in combination with Pegasys for 48 weeks with the efficacy and safety of standard dose Copegus in combination with Pegasys for 48 weeks in this population
• To compare the efficacy and safety of 360 µg induction dosing of Pegasys for 12 weeks followed by a 180 µg maintenance dose of Pegasys for 36 weeks in combination with higher dose Copegus with the efficacy and safety of the approved Pegasys plus Copegus dosing regimen in this population
• To determine if treatment-related lymphopenia and neutropenia are associated with the occurrence of serious infections
• To evaluate pegylated interferon alfa-2a (PEG-IFN alfa-2a) and ribavirin drug exposures and their relationship to viral response in a subset of patients treated with 360 µg induction dosing of Pegasys and with higher doses of Copegus within the four study groups,
- etc.
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Secondary ID(s)
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2005-005507-41-HU
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NV18210
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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