Purpura, Thrombocytopaenic, IdiopathicPhase 2NCT00102739
SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)
A Phase 2 study testing SB497115 in people with Purpura, Thrombocytopaenic, Idiopathic, run by GlaxoSmithKline at 30 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Purpura, Thrombocytopaenic, Idiopathic
- What is being tested?
- SB497115
- How many people
- 99 participants
- Where
- 30 sitesin 13 countries
- Study dates
- Feb 2005to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 13 countries.
30 sites in 13 countries
United Kingdom7 sites
GSK Investigational Site
Liverpool, L7 8XP
GSK Investigational Site
London, E1 1BB
GSK Investigational Site
London, WC1E 6HX
GSK Investigational Site
Manchester, M13 9WL
GSK Investigational Site
Reading, Berkshire, RG1 7AN
GSK Investigational Site
Swansea, SA6 6NL
GSK Investigational Site
Taunton, Somerset, TA1 5DA
Greece3 sites
GSK Investigational Site
Athens, 10676
GSK Investigational Site
Athens
GSK Investigational Site
Thessaloniki, 57010
Russia3 sites
GSK Investigational Site
Moscow, 105 229
GSK Investigational Site
Moscow, 125167
GSK Investigational Site
Novosibirsk, 630087
South Korea3 sites
GSK Investigational Site
Seoul, 136-705
GSK Investigational Site
Seoul, 138-736
GSK Investigational Site
Seoul, 140-743
Thailand3 sites
GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Chiang Mai, 50000
GSK Investigational Site
Khon Kaen, 40002
Hong Kong2 sites
GSK Investigational Site
Pokfulam
GSK Investigational Site
Shatin
Romania2 sites
GSK Investigational Site
Bucharest, 022328
GSK Investigational Site
Bucharest, 050098
Slovenia2 sites
GSK Investigational Site
Ljubljana, 1000
GSK Investigational Site
Maribor, 2000
About this study
Official title: See Detailed Description
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.
Read the detailed description
A double-blind, randomized, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of SB-497119-GR, a thrombopoietin receptor agonist, administered at 30, 50, and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory, chronic immune thrombocytopenia purpura
- Conditions
- Purpura, Thrombocytopaenic, Idiopathic
- Being tested
- SB497115
- Keywords
- thrombopoietin, immune thrombocytopenic purpura, platelets, chronic thrombocytopenia
- Medical subject headings
- Purpura, Jacobs syndrome, Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB497115Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (1)
Safety, tolerability, PK, PD, symptoms associated with ITP, and QoL, odds of response vs placebo during weeks 2 to 6 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2005 (estimated)
- Study startFeb 2005
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Purpura, Thrombocytopaenic, IdiopathicStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102739
- Sponsor's protocol ID
- TRA100773
- Status last verified
- Nov 2012
- First submitted
- 1 Feb 2005
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18046028Gibiansky 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.
PubMed 20663993Tarantino MD, Fogarty P, Mayer B, Vasey SY, Brainsky A. Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia. Blood Coagul Fibrinolysis. 2013 Apr;24(3):284-96. doi: 10.1097/MBC.0b013e32835fac99.
PubMed 23492914Bussel JB, Provan D, Shamsi T, Cheng G, Psaila B, Kovaleva L, Salama A, Jenkins JM, Roychowdhury D, Mayer B, Stone N, Arning M. Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Feb 21;373(9664):641-8. doi: 10.1016/S0140-6736(09)60402-5.
PubMed 19231632
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- See Detailed Description
- ClinicalTrials.gov ID
- NCT00102739
- Acronym / sponsor ID
- TRA100773
- Conditions
- Purpura, Thrombocytopaenic, Idiopathic
- Keywords
- thrombopoietin, immune thrombocytopenic purpura, platelets, chronic thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 2 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A double-blind, randomized, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of SB-497119-GR, a thrombopoietin receptor agonist, administered at 30, 50, and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory, chronic immune thrombocytopenia purpura
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB497115 | Drug | – |
Primary outcome
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.
1 secondary outcome
Safety, tolerability, PK, PD, symptoms associated with ITP, and QoL, odds of response vs placebo during weeks 2 to 6 of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
- Background: PubMed 18046028Bussel 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.
- Background: PubMed 20663993Gibiansky 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.
- Derived from this study: PubMed 23492914Tarantino MD, Fogarty P, Mayer B, Vasey SY, Brainsky A. Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia. Blood Coagul Fibrinolysis. 2013 Apr;24(3):284-96. doi: 10.1097/MBC.0b013e32835fac99.
- Derived from this study: PubMed 19231632Bussel JB, Provan D, Shamsi T, Cheng G, Psaila B, Kovaleva L, Salama A, Jenkins JM, Roychowdhury D, Mayer B, Stone N, Arning M. Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Feb 21;373(9664):641-8. doi: 10.1016/S0140-6736(09)60402-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
30 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB497115 in people with Purpura, Thrombocytopaenic, Idiopathic, run by GlaxoSmithKline at 30 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United Kingdom, Greece, Russia, South Korea, Thailand and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00102739, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.