Search results - Portal of Medical Data Models (MDM-Portal)

Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab panels NCT00516321

- 9/20/21 - 1 form, 6 itemgroups, 71 items, 1 language

Itemgroups: Chemistry, Haematology, Liver Chemistry Assessments, Renal Laboratory Parameters, Urinalysis Dipstick, Other Laboratory Screenings

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR). NCT00516321 https://clinicaltrials.gov/ct2/show/NCT00516321 Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin

Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab Panels NCT00529568

- 9/20/21 - 1 form, 6 itemgroups, 72 items, 1 language

Itemgroups: Chemistry, Haematology, Liver Chemistry Assessments, Renal Laboratory Parameters, Urinalysis Dipstick, Other Laboratory Screenings

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR). NCT00529568 https://clinicaltrials.gov/ct2/show/NCT00529568 Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment Official Title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)

Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Infection Lab panels NCT00996216

- 9/20/21 - 1 form, 6 itemgroups, 49 items, 1 language

Itemgroups: Clinical Chemistry, Haematology, Liver Chemistry, Renal Assessments, Urinalysis Dipstick, Other Laboratory Screenings

The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy. NCT00996216 https://clinicaltrials.gov/ct2/show/NCT00996216 Study Type: Interventional Study Design: Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: An Open-label, Multi-centre Rollover Study to Assess the Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a or Peginterferon Alfa-2b Plus Ribavirin)

dbGaP phs000873 Exome sequencing of a family with thrombocytopenia and leukemia - Eligibility

- 3/26/24 - 6 forms, 1 itemgroup, 3 items, 1 language

Itemgroup: IG.elig

Principal Investigator: Jorge Di Paola, MD, University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA MeSH: Thrombocytopenia,Abnormal Erythrocytes,B-Cell Leukemia https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000873 A family with a history of bleeding, variable thrombocytopenia, red cell macrocytosis and two cases of pre B-cell acute lymphoblastic leukemia was studied in a single visit. The family was assessed for bleeding history using a bleeding questionnaire. Additionally, complete blood counts were measured and whole blood was collected from five affected individuals and three unaffected individuals for DNA extraction and whole exome sequencing. The goal of this study is to determine the genetic cause of thrombocytopenia, red cell macrocytosis, and predisposition to leukemia in a family. It is hoped that the information obtained from this study will help researchers understand the genetic and molecular basis of platelet and red cell production, as well as leukemia predisposition.

pht004555.v1.p1

1 itemgroup 3 items

pht004556.v1.p1

1 itemgroup 5 items

pht004557.v1.p1

1 itemgroup 3 items

pht004558.v1.p1

1 itemgroup 5 items

pht004559.v1.p1

1 itemgroup 7 items

Eligibility Thrombocytopenia NCT01484314

- 9/22/21 - 1 form, 2 itemgroups, 11 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01484314

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Adverse events

- 1/23/21 - 1 form, 2 itemgroups, 27 items, 1 language

Itemgroups: Administrative Data, Adverse events

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This document is to be filled out if and whenever an adverse event occurs during the study period.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Pharmacogenetic Research

- 1/9/21 - 1 form, 3 itemgroups, 14 items, 1 language

Itemgroups: Administrative Data, PGx-Pharmacogenetic Research Consent, PGx-Pharmacogenetic Research Withdrawal of Consent

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out by all participants to document, whether pharmacogenetic research consent is either given, not given or withdrawn after it had been previously given.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Concomitant medication

- 1/9/21 - 1 form, 2 itemgroups, 16 items, 1 language

Itemgroups: Administrative Data, Concomitant Medications

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out, if concomitant medication has been taken by subject during the study.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Pharmacokinetics

- 12/18/20 - 1 form, 3 itemgroups, 7 items, 1 language

Itemgroups: Administrative Data, Dosing date and time, Pharmacokinetics Blood

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the P1 D1 and P2 D1 Visit.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Study Conclusion and Pregnancy Information

- 12/18/20 - 1 form, 3 itemgroups, 11 items, 1 language

Itemgroups: Administrative Data, Study Conclusion, Pregnancy information

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Follow-Up Visit.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Electronically transferred lab data

- 12/18/20 - 1 form, 2 itemgroups, 7 items, 1 language

Itemgroups: Administrative Data, Safety Labs

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Screening, the P1 D-1, P1 D1, P2 D-1, P2 D1, the Follow-Up Visits and in case of repeat measurements.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Vital Signs, P1 D-1, P1 D1, P2 D-1, P2 D1 and Repeats

- 12/18/20 - 1 form, 3 itemgroups, 9 items, 1 language

Itemgroups: Administrative Data, Dosing date and time, Vital Signs Measurement

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the P1 D-1, P1 D1, P2 D-1 and P2 D1 Visits and possible Repeat Measurements . Slight variations are remarked under the concerning items.

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