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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037 - Blood products and blood supportive care products

- 12/5/19 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Administrative Data, Blood products and blood supportive care products
Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This form is for documentation of any blood products or blood supportive care products given during the study. Part of Logs and Repeat.

DZHK Data Catalogue - Biobanking Basic Set

- 10/10/19 - 1 form, 6 itemgroups, 29 items, 2 languages
Itemgroups: Number of aliquot tubes, Blood and Urine collection, Lab process steps, Sample properties (blood), Sample properties (urine), Comments
With permission from the DZHK administrative office. http://dzhk.de The DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung e.V.; German Center for Cardiovascular Research) is a joint cooperation of twenty-eight institutions in seven locations throughout Germany to develop a common research strategy. They developed a data catalogue with metadata and data as well as information about available biological materials from all their studies. For more information on the data catalogue and access to actual data and biosamples please visit https://dzhk.de/en/resources/data-manual/ . This version contains the metadata part only. The form Biobanking Basic Set is used to document the quality of samples of the Basic Set. The Basic Set consists of EDTA plasma, serum, citrate plasma, buffy coat and urine. The documentation is to be performed according to the DZHK's Biobanking SOPs, which can be accessed at https://dzhk.de/en/resources/sops/ (or https://dzhk.de/ressourcen/sops/ for the German language versions). The SOPs for this form are "Collection of Biomaterials from Blood and Urine" (version 1.1, valid as of 15/12/2014) and "Biomaterial Processing Basic Set" (version 1.1, valid as of 15/12/2014) for the English language versions, and "Gewinnung von Biomaterialien aus Blut und Urin" (version 1.1, valid as of 15/12/2014) and "Biomaterialverarbeitung Basis-Set" (versin 1.1, valid as of 15/12/2014) for the German language version. The collection of biomaterials is carried out in accordance with local regulations. Deviations from the following requirements will not result in the exclusion of the patient/test subject from the study. Collection of blood: Appropriate means of disposal for needles, swabs, etc. Period of rest in unaltered body position prior to blood collection: 5 minutes. Site of collection on patient/test subject: cubital vein. Tourniquet time < 1 minute. Specimens should be drawn in the following order: serum, citrate, EDTA. The tourniquet should be released once collection of blood has begun, i.e. when blood flow into the primary receptacle is visible. No repeat clenching of the fist. Invert immediately while exchanging the primary receptacles. Store the primary receptacles vertically in the primary receptacle/tube rack. Collection of urine: Label the urine cup using the sticker intended for that purpose. Inform the patient/test subject using the information sheet “Collecting a Mid-Stream UrineSpecimen”. Spontaneous urine collection. Immediately after urine specimen is given: document the time the urine specimen was collected and the appearance of the urine on the Biomaterial Collection Form. If patient/test subject is actively menstruating: Make a note of this on the Biomaterial Collection Form.

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