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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00102739




Registration number
NCT00102739
Ethics application status
Date submitted
1/02/2005
Date registered
2/02/2005
Date last updated
15/04/2013

Titles & IDs
Public title
SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)
Scientific title
See Detailed Description
Secondary ID [1] 0 0
TRA100773
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Purpura, Thrombocytopaenic, Idiopathic 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SB497115

Treatment: Drugs: SB497115
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment response, assessed by the proportion of patients with platelet counts of =50, 000/µL (compared with baseline count of <30, 000/µL) after 42 days of treatment.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Safety, tolerability, PK, PD, symptoms associated with ITP, and QoL, odds of response vs placebo during weeks 2 to 6 of the study.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Inclusion criteria:

- Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have
failed at least one treatment for chronic low platelet count.

- Patients receiving chronic maintenance steroid therapy must have received a stable
dose for at least 1 month.

- Normal PT and PTT.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- History of clotting disorder.

- Females who are pregnant or are receiving hormone replacement therapy or systemic
contraceptives.

- History of alcohol/drug abuse or dependence within 1 year.

- Use of aspirin, aspirin-containing compounds, salicylates, antacids, rosuvastatin,
pravastatin, non-steroidal anti-inflammatory drugs during the study and within 3 weeks
prior to starting the study.

- History of HIV infection or active infection with Hepatitis B or C.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2007
Sample size
Target
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Hessen
Country [2] 0 0
Greece
State/province [2] 0 0
Athens
Country [3] 0 0
Greece
State/province [3] 0 0
Thessaloniki
Country [4] 0 0
Hong Kong
State/province [4] 0 0
Pokfulam
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Shatin
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
Pakistan
State/province [8] 0 0
Lahore
Country [9] 0 0
Poland
State/province [9] 0 0
Lodz
Country [10] 0 0
Romania
State/province [10] 0 0
Bucharest
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Moscow
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Novosibirsk
Country [13] 0 0
Slovenia
State/province [13] 0 0
Ljubljana
Country [14] 0 0
Slovenia
State/province [14] 0 0
Maribor
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taipei
Country [16] 0 0
Thailand
State/province [16] 0 0
Bangkok
Country [17] 0 0
Thailand
State/province [17] 0 0
ChiangMai
Country [18] 0 0
Thailand
State/province [18] 0 0
Khon Kaen
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Berkshire
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Somerset
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Liverpool
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Manchester
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a double-blind, randomized, placebo-controlled, parallel group, repeat-dose,
study conducted in two parts (Part A and Part B) examining 30, 50, and 75 mg doses of
SB-497115-GR as a treatment for patients with ITP who have failed prior therapy. The study is
designed to determine the proportion of patients with a platelet count =50,000/µL after 42
days. In Part B, 99 newly-recruited subjects will be randomized to one of two dosing arms in
a 2:1 ratio of active:placebo. During the 6 week study period, subjects will start on placebo
or active drug (50 mg) and may have a dose increase to 75 mg based upon their platelet count
at day 22.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00102739
Trial related presentations / publications
Bussel JB, Cheng G, Saleh MN, Psaila B, Kovaleva L, Meddeb B, Kloczko J, Hassani H, Mayer B, Stone NL, Arning M, Provan D, Jenkins JM. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med. 2007 Nov 29;357(22):2237-47. doi: 10.1056/NEJMoa073275.
Gibiansky E, Zhang J, Williams D, Wang Z, Ouellet D. Population pharmacokinetics of eltrombopag in healthy subjects and patients with chronic idiopathic thrombocytopenic purpura. J Clin Pharmacol. 2011 Jun;51(6):842-56. doi: 10.1177/0091270010375427. Epub 2010 Jul 27.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00102739