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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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4 January 2022 |
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Main ID: |
EUCTR2008-002022-10-DE |
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Date of registration:
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17/02/2009 |
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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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An open-label, multicenter protocol providing pegylated interferon alfa-2a (PEGASYS) as monotherapy or in combination with ribavirin (COPEGUS) for patients with chronic hepatitis C who have participated in previous Roche or Roche partner protocols.
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Scientific title:
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An open-label, multicenter protocol providing pegylated interferon alfa-2a (PEGASYS) as monotherapy or in combination with ribavirin (COPEGUS) for patients with chronic hepatitis C who have participated in previous Roche or Roche partner protocols. |
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Date of first enrolment:
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16/06/2009 |
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Target sample size:
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252 |
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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:2008-002022-10 |
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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: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
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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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- As described in protocol section 2 (Objectives of the study)
- Be eligible for treatment or re-treatment as defined in the donor protocol
- Have completed safety and efficacy assessments as defined in the donor protocol
without violation or major deviation
- Have had at least a 6 month washout period from date of last dose from donor
protocol NV19865; To ensure a proper balance between risk and benefit, a longer
washout period should be considered for patients who experienced lymphopenia
for extended periods of time in donor protocol NV19865
- Have not received any other anti-HCV treatment after the completion of the donor
protocol
- Have a negative pregnancy test (for females of childbearing potential)
documented within the 24-hour period prior to the first dose of study drugs.
Additionnally, fertile patients (males and females) must use two reliable forms of
effective contraception (combined) during the entire period of the study (treatment
and follow-up) in accordance with locally approved label for ribavirin (COPEGUS).
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:
- Females who are pregnant or breast-feeding
- Male partners of females who are pregnant
- Patients with hemoglobinopathies
- Hepatic decompensation (Child-Pugh class B and C) before or during treatment
- Neutrophil counts < 1500 cells/mm3, platelet counts < 90000 cells/mm3 or Hgb <
12 g/dL in females or < 13 g/dL in males, lymphocyte counts <1500 cells/mm3
- Non-responder patients (defined as patients previously treated with PEGASYS and
COPEGUS combination therapy at standard doses, with greater than or equal to
80% compliance (defined as having taken greater than or equal to 80% of
PEGASYS doses, greater than or equal to 80% of COPEGUS doses for greater than
or equal to 80% of the time between day of first dose and week 12), for at least 12
weeks and did not achieve at least a 2 log drop from their baseline viral load)
- History of:
- Severe neuropsychiatric disease, especially depression
- Significant or unstable cardiac disease
- Inadequately controlled hypothyroidism or hyperthyroidism
- Inadequately controlled hyperglycemia, hypoglycemia or diabetes mellitus
- Immunologically mediated disease including myositis, inflammatory bowel disease,
idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune
hemolytic anemia, scleroderma, severe psoriasis, interstitial nephritis, rheumatoid
arthritis requiring more than intermittent nonsteroidal anti-inflammatory
medications for management
- Chronic pulmonary disease associated with functional limitation
- Severe retinopathy, optic neuropathy or other serious ocular adverse event
- Major organ transplantation with an existing functional graft
- History or other evidence of a medical condition associated with chronic liver
disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson’s disease, alpha1
antitrypsin deficiency, alcoholic liver disease, and toxin exposures)
- Evidence of an active or suspected cancer or a history of malignancy where the
risk of recurrence is greater than or equal to 20% within 2 years. Patients with a
lesion suspicious for hepatic malignancy on the screening imaging study will only
be eligible if the likelihood of carcinoma is less than or equal to 10% following an
appropriate evaluation.
- History of any systemic anti-neoplastic or immunomodulatory treatments
(including steroids given at non-physiologic doses and radiation)
- History or other evidence of severe illness or any other conditions (e.g.
pancreatitis) which would make the patient, in the opinion of the investigator,
unsuitable for the study
- Evidence of alcohol and/or drug abuse
- Inability or unwillingness to provide informed consent or abide by the
requirements of the study.
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
MedDRA version: 9.1
Level: LLT
Classification code 10008912
Term: Chronic hepatitis C
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Intervention(s)
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Trade Name: Pegasys
Pharmaceutical Form: Solution for injection
INN or Proposed INN: peginterferon alfa-2a
CAS Number: 198153-51-4
Current Sponsor code: Ro 25-8310
Other descriptive name: pegylated interferon alfa-2a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-
Trade Name: Copegus 200 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ribavirin
CAS Number: 36791-04-5
Current Sponsor code: Ro 20-9963
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
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Primary Outcome(s)
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Main Objective: To provide treatment or re-treatment with Pegasys as monotherapy or in combination with Copegus, to patients with chronic hepatitis C (CHC) who participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol (‘donor’ protocol).
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Primary end point(s): n.a.
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Secondary Objective: n.a.
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Secondary ID(s)
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2008-002022-10-ES
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NV21928
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 16/06/2009
Contact:
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