Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)

NCT00540423 | Completed Phase 3 Results

• 1 other identifier: 108109
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 7

Brief Summary

This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients

Conditions

Chronic Idiopathic Thrombocytopenic Purpura; Purpura, Thrombocytopenic, Idiopathic

Keywords

thrombopoietin,; immunosuppressive therapy,; eltrombopag,; idiopathic thrombocytopenic purpura,; blood platelet,; splenectomy

Outcome Measures

Primary Outcomes (2)

• Number of Responders at Week 6

  A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter).

  Week 6

• Percentage of Participants for Whom at Least 75% of Their Assessments During the Course of 26 Weeks of SB-497115-GR Treatment Met the Definition of Responders

  A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.

  Week 26

Secondary Outcomes (22)

• Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6

  Weeks 2 through 6

• Percentage of Responders at Each Visit

  Days 8, 15, 22, 29, 36, and 43

• Mean Platelet Count at Each Visit

  Baseline and Days 8, 15, 22, 29, 36, and 43

• Mean Change From Baseline in Platelet Counts at Each Visit

  Baseline and Days 8, 15, 22, 29, 36, and 43

• Percentage of Participants With Bleeding Episodes Since the Last Visit

  Days 1, 8, 15, 22, 29, 36, and 43

Study Arms (2)

SB-497115-GR group

EXPERIMENTAL

Subject will initiate treatment with SB-497115-GR 12.5mg once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR may be adjusted at 12.5mg, 25mg or 50mg.

Drug: SB-497115-GR 12.5mg; Drug: SB-497115-GR 25mg; Drug: SB-497115-GR 50 mg

placebo group

PLACEBO COMPARATOR

Subject will initiate treatment with SB-497115-GR 12.5mg matching placebo once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR 12.5mg matching placebo may be increased to 2 tablet of SB-497115-GR 12.5mg matching placebo.

Drug: SB-497115-GR 12.5mg matching placebo

Interventions

SB-497115-GR 12.5mg DRUG

SB-497115-GR 12.5mg tablet once a day

SB-497115-GR group

SB-497115-GR 25mg DRUG

SB-497115-GR 25mg tablet once a day

SB-497115-GR group

SB-497115-GR 12.5mg matching placebo DRUG

SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day

placebo group

SB-497115-GR 50 mg DRUG

SB-497115-GR 25mg tablet x2 once a day

Also known as: SB-497115-GR 50mg

SB-497115-GR group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects eligible for enrollment in the study must meet all of the following criteria.
• At Screening (Week -4 or -3)
• Diagnosed with ITP for at least 6 months prior to screening.
• Have a platelet count of \<30,000/µL.
• Previously treated refractory or relapsed patients who have failed to achieve a platelet count of \>=30,000/µL despite one or more prior therapies (either H. pylori eradication, corticosteroids, splenectomy, danazol or immunosuppressive drugs). (Note: Previous H. pylori eradication must have been completed at least 3 months prior to screening and clearly be ineffective).
• Previous treatment for ITP with splenectomy, rituximab, and cyclophosphamide must have been completed at Week -4 and clearly be ineffective.
• Subjects treated with cyclosporine A, mycophenolate mofetil or danazol must be receiving a dose that has been stable for at least 3 months prior to screening."
• A complete blood count (CBC) within the reference range, with the following exceptions
• The following clinical chemistries MUST NOT exceed 1.2 times the normal reference range:creatinine, ALT, AST, total bilirubin and alkaline phosphatase.
• Albumin must be within 80 to 120% of normal range.
• Subject is \>=20 years old.
• Female subjects must either be:
• of non-childbearing potential (bilateral tubal ligation or post-menopausal), or
• of childbearing potential and have a negative pregnancy test and agree to use contraceptive methods specified in the GSK List of Highly Effective Methods for Avoidance of Pregnancy
• Hospitalization status: No restriction.

You may not qualify if:

• Subjects meeting any of the following criteria must not be enrolled in the study.
• At Screening (Week -4 or -3)
• Any severe medical condition (cardiac, hepatic or renal disorder) other than chronic ITP. (Note: ""Severe"" is defined as \>=Grade 3 as a rule according to the ""Classification of the Severity of Adverse Experiences (PAB/SD Notification No.80, dated 29 June 1992) (Appendix X).)
• History of suspected or confirmed arterial or venous thrombosis (e.g., myocardial infarction, deep vein thrombosis) within the last 1 year.
• History of drug/alcohol abuse or dependence within 1 year prior to screening.
• Previous treatment with SB-497115-GR.
• Suspected blood disorder other than ITP.
• Suspected platelet aggregation abnormality.
• Suspected cyclic thrombocytopenia
• Current or history of HIV infection or hepatitis B virus or hepatitis C virus infections.
• Current or history of malignancy (Exception: Subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible).
• Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
• Subjects who are deemed unsuitable for the study by the investigator (or sub investigator).
• Subjects who are participating in any other clinical trials at present or ones who previously participated in clinical trials and were treated with investigational products within last one month." At Randomization (Week 0)
• Subject wishes to withdraw consent.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Gifu, 503-8502, Japan

Location

GSK Investigational Site

Hiroshima, 734-8551, Japan

Location

GSK Investigational Site

Ibaraki, 305-8576, Japan

Location

GSK Investigational Site

Osaka, 565-0871, Japan

Location

GSK Investigational Site

Osaka, 596-8501, Japan

Location

GSK Investigational Site

Tochigi, 329-0498, Japan

Location

GSK Investigational Site

Tokyo, 160-8582, Japan

Location

Related Publications (1)

• Tomiyama Y, Miyakawa Y, Okamoto S, Katsutani S, Kimura A, Okoshi Y, Ninomiya H, Kosugi H, Nomura S, Ozaki K, Ikeda Y, Hattori T, Katsura K, Kanakura Y. A lower starting dose of eltrombopag is efficacious in Japanese patients with previously treated chronic immune thrombocytopenia. J Thromb Haemost. 2012 May;10(5):799-806. doi: 10.1111/j.1538-7836.2012.04695.x.

  PMID: 22409309 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Jacobs syndrome

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 30, 2011
• Results First Posted: December 31, 2009

Record last verified: 2011-03

Locations

JP (7)