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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:	EUCTR
Last refreshed on:	7 August 2012
Main ID:	EUCTR2008-002022-10-ES
Date of registration:	25/06/2008
Prospective Registration:	Yes
Primary sponsor:	F. Hoffmann-La Roche Ltd
Public title:	Protocolo multicéntrico abierto en el que se proporciona interferón pegilado alfa-2a (PEGASYS®) en monoterapia o en combinación con ribavirina (COPEGUS®) a pacientes con hepatitis C crónica que han participado en protocolos de Roche anteriores. 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
Scientific title:	Protocolo multicéntrico abierto en el que se proporciona interferón pegilado alfa-2a (PEGASYS®) en monoterapia o en combinación con ribavirina (COPEGUS®) a pacientes con hepatitis C crónica que han participado en protocolos de Roche anteriores. 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
Date of first enrolment:	23/09/2008
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002022-10
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Austria	France	Germany	Spain

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

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 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
- Non-responder patients (defined as patients previously treated with PEGASYS and
COPEGUS combination therapy at standard doses 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
- 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

Health Condition(s) or Problem(s) studied

Chronic hepatitis C Hepatitis C crónica
MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C

Intervention(s)

Trade Name: Pegasys, 180 microgramos, solución inyectable
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: PEGINTERFERON ALFA 2A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-

Trade Name: COPEGUS 200 mg comprimidos con cubierta pelicular
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIBAVIRINA
CAS Number: 36791-04-5
Other descriptive name: RIBAVIRIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Pegasys, 180 microgramos, solución inyectable
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: PEGINTERFERON ALFA 2A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-

Trade Name: PEGASYS, 180 microgramos, solución inyectable en jeringa precargada
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGINTERFERON ALFA 2A
Current Sponsor code: Ro 25-8310
Other descriptive name: PEGINTERFERON ALFA 2A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-

Trade Name: PEGASYS, 180 microgramos, solución inyectable en jeringa precargada
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGINTERFERON ALFA 2A
Current Sponsor code: Ro 25-8310
Other descriptive name: PEGINTERFERON ALFA 2A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-

Trade Name: Pegasys, 180 microgramos, solución inyectable en jeringa precargada
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: PEGINTERFERON ALFA 2A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-

Primary Outcome(s)

Main Objective: To provide treatment or re-treatment to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment with PEGASYS as monotherapy or in combination with COPEGUS was promised or deemed appropriate following completion of the original protocol (?donor? protocol).

Primary end point(s): n.a.

Secondary Objective: n.a.

Secondary Outcome(s)

Secondary ID(s)

NV21928

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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