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Main
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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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25 November 2019 |
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Main ID: |
EUCTR2005-000043-28-GB |
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Date of registration:
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16/03/2005 |
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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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A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension
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Scientific title:
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A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension |
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Date of first enrolment:
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19/04/2005 |
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Target sample size:
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170 |
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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:2005-000043-28 |
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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: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
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): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Germany
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Ireland
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Italy
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Spain
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Sweden
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Patients have fully completed the TRIUMPH (C04-001), SHEPHERD (C04-002), or X03-001 studies, or, TRIUMPH patients who have discontinued receiving investigational product prior to the Visit 18 due to lack of efficacy or exacerbation of symptoms of PNH and have completed, at minimum, all efficacy and safety procedures at Visits 4, 5, 6, 7, 9, 11, 13, 15, 17 and 18.
2. Patient must be willing and able to give written informed consent.
3. Patient must avoid conception during the trial using a method that is most appropriate for their physical state and culture.
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. Patients who have early terminated from the SHEPHERD (C04-002) or X03- 001 studies;
2. Patients who have withdrawn from the TRIUMPH study (C04-001) due to an adverse event;
3. Females: pregnant, breast-feeding, or intending to conceive during the course of the study, including the Safety Follow-up Visits;
4. Any condition that, in the opinion of the Investigator, could increase the patient’s risk by participating in the study or confound the outcome 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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paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0
Level: PT
Classification code 10034042
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Intervention(s)
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Product Name: eculizumab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: eculizumab
Current Sponsor code: h5G1.1-mAb
Other descriptive name: Anti-C5 antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Main Objective: The primary objective is to evaluate the long-term safety of eculizumab in patients with transfusion-dependent hemolytic PNH.
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Primary end point(s): Primary endpoints are treatment-emergent adverse events (AEs), clinical laboratory and electrocardiogram data, and vital signs. These data will be summarized for safety-evaluable patients. Adverse events will be assigned MedDRA? preferred terms and tabulated as incidence rates.
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Secondary Objective:
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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