Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00102739