A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

Condition(s) targeted: Chronic Idiopathic Thrombocytopenic Purpura

Intervention: Gammaplex, intravenous immunoglobulin (Biological); Gammaplex (Biological); Gammaplex (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bio Products Laboratory

Official(s) and/or principal investigator(s):
Clive H Dash, MD, Principal Investigator, Affiliation: Bio Products Laboratory

The primary objective is to determine if BPL's GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of a historical control. The secondary objectives are: 1) to determine the safety of GAMMAPLEX at the dosage used in this study. 2) to determine if GAMMAPLEX maintains platelet counts of ³ 50 x 109/L in subjects with chronic ITP for a period of time similar to that of a historical control.

Official title: A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura

Study design: Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary objective is to determine if BPL's GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of a historical control.

Secondary outcome: To determine the safety of GAMMAPLEX at the dosage used in this study and to determine if GAMMAPLEX maintains platelet counts of ³ 50 x 109/L in subjects with chronic ITP for a period of time similar to that of a historical control.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Males and females aged between 18 and 70 years.

2. Confirmed diagnosis of chronic ITP of at least 6 months duration.

3. Platelet count of less than or equal to 20 x 10 9/L at enrollment.

4. Absence of other conditions that, in the opinion of the investigator, could cause thrombocytopenia.

5. If subjects are currently being treated with corticosteroids the treatment regimen/dose must have been stable (for a minimum of 2 weeks before screening). However, subjects must remain on a stable treatment regimen. If there is any intent to alter the corticosteroid treatment regimen (e. g., tapering of corticosteroids) before Day 10, subjects may not be included in the study.

6. If subjects are currently being treated with cyclophosphamide, azathioprine or attenuated androgens, the treatment regimen and dose must have been stable for a minimum of 2 months before screening. However, if there is any intent to alter the treatment regimen before Day 10, subjects may not be included in the study.

7. Splenectomized subjects and both Rh(D)+ and Rh(D)- subjects may be included.

8. The subject has signed an informed consent form (subjects must be at least 18 years old), and/or the subject's legal guardian has signed the informed consent form if indicated

9. If a subject is a female of child-bearing potential, she must have a negative result on a urine-based HCG pregnancy test.

10. If a subject is a female who is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study.

Exclusion Criteria:

1. The subject has a history of any severe or anaphylactic reaction to blood or any blood-derived product, or any severe reaction to IGIV or any other IgG preparation.

2. The subject is known to be intolerant to any component of the investigational product.

3. The subject has received any live virus vaccine within the last 3 months prior to Day1.

4. The subject has received an IGIV preparation within 1 month prior to Day 1. 5) The subject is currently receiving, or has received, any investigational agent within the 1 month prior to Day 1. 6) The subject has received any blood, blood product, or blood derivative within the 1 month prior to Day 1. 7) The subject has received Rituximab within the 3 months before Day 1. 8) The subject is pregnant or is nursing. 9) The subject is positive for any of the following at screening: HBsAg, NAT for HCV, NAT for HIV, Antibodies to HCV or HIV 1 or 2. 10) The subject, at screening, has levels greater than 2. 5 times the upper limit of normal, as defined by the central laboratory, of alanine aminotransferase or aspartate aminotransferase. 11) The subject has a severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or BUN greater than 2. 5 times the upper limit of normal for the range of the laboratory doing the analysis); the subject is on dialysis; the subject has a history of acute renal failure. 12) The subject is known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months. 13) The subject has a history of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy. 14 The subject has any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina. 15) The subject suffers from any acute or chronic medical conditions (e. g., renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing enteropathy) that, in the opinion of the investigator, may interfere with the conduct of the study. 16) The subject has an acquired medical condition, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (defined as an absolute neutrophil count (ANC) < 1 x 109/L). 17) The subject has non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg). 18) The subject is anemic (hemoglobin <10 g/dL) at screening. 19) The subject is unlikely to adhere to the protocol requirements of the study or is likely to be uncooperative.

Hospital Britanico, Buenos Aires C1280AEB, Argentina; Recruiting
Laura Bullorsky, Phone: 005411 4309 6400, Ext: 2560, Email: laurabullo@hotmail.com
Eduardo Bullorsky, MD, Principal Investigator

Centro de Educación Médica e Investigaciones Clinicas Dr. Norberto Quirno (CEMIC), Buenos Aires C1431FWO, Argentina; Recruiting
Stella Zarza, Phone: 0054 11 4546 8285, Email: stezarza@yahoo.com.ar
Juan Carlos Dupont, MD, Principal Investigator

I. A. D. T. (Instituto Argentino de Diagnóstico y Tratamiento), Buenos Aires C1122AAL, Argentina; Recruiting
Cecilia Marin, Phone: 005411 49638661, Email: ce.marin@gmail.com
Olivia Avila
Claudio Iastrebner, MD, Principal Investigator

Hospital Privado de Cordoba, Cordoba X5016KEH, Argentina; Recruiting
Lucrecia Audisio, Phone: 0054 3514688243, Email: investigacion.onco.hp@gmail.com
Juan Garcia, MD, Principal Investigator

J.R. Vidal Hospital, Corrientes, Argentina; Recruiting
Maria Gabriela Erro, Phone: 03783 421 225, Email: gabrielaerro@gmail.com
Emilio Lanari, MD, Principal Investigator

CER San Juan, San Juan 5400, Argentina; Recruiting
Mayra Bacil, Phone: 0054 0264 4211086, Email: mayrabacil@cersanjuan.com.ar
Maria Gomez, MD, Principal Investigator

Sir Ganga Ram Hospital, New Delhi 110060, India; Recruiting
Ajeet Nanda, Phone: 91-11-43594466, Email: nanda.ajeet@gmail.com
Anupama Jaggia, MD, Principal Investigator

Apollo Hospitals, Hyderabad, Andhra Pradesh 500003, India; Recruiting
Venkat, Phone: 91-9848018804, Email: cvpr01@aherf-smo.org
S.V.S.S. Prasad, MD, Principal Investigator

Mahavir Hospital, Hyderabad, Andhra Pradesh 500054, India; Recruiting
Madhuri Mahajan, Phone: 91-40-23497392, Email: madhurisamirmahajan@yahoo.com
Srinivas Kulkarni, MD, Principal Investigator

M. S Ramaiah Hospital, Karnataka, Bangalore 560054, India; Recruiting
Vatsala Jayant, MD, Phone: 91-080-40528403, Email: vatsala.gm@metropolisindia.com
Arun Narayan, MD, Principal Investigator

Hospital Churruca, Capital Federal, Buenos Aires C1437JCP, Argentina; Recruiting
Laura Valicenti, Phone: 0054 11 4912 3049/3949/5045, Email: hematologiachurruca@gmail.com
Luis Palmer, MD, Principal Investigator

Hospital Italiano de La Plata, La Plata, Buenos Aires B1900AXU, Argentina; Recruiting
Cecilia Benetti, Phone: 0054 02214537200, Email: ceciliabenetti@live.com.ar
Alicia Enrico, MD, Principal Investigator

Mid Florida Hematology & Oncology, Orange City, Florida 32763, United States; Completed

Vedanta, Ahmedabad, Gujarat 380009, India; Recruiting
Hiren Shah, MD, Phone: 09825407551, Email: hirenshah27@gmail.com
Sandip A Shah, MD, Principal Investigator

Rush University Medical Center, Chicago, Illinois 60612, United States; Terminated

Vinaya Hospital & research Centre, Mangalore, Karnataka 5750003, India; Recruiting
S Nithin, MD, Phone: 09900412690, Email: drnithins@hotmail.com
Hansraj Alva, MD, Principal Investigator

Kasturba Medical College, Manipal Acunova KMC Research Centre, Mangalore, Karnataka 575001, India; Recruiting
Meera Lobo, Phone: 09880200593, Email: meera.lobo@ecronacunova.com
M Chakrapani, MD, Principal Investigator

Father Muller Medical College Hospital, Mangalore, Karnataka 575002, India; Recruiting
Gouri Shenoy, Phone: 91-824-2238285
B. M. Venkatesha, MD, Principal Investigator

Deenanath Mangeshkar Hospital, Pune, Maharashtra 411004, India; Recruiting
Shweta Shende, Phone: 91-9766249644, Email: shwetashende@gmail.com
Sameer Melinkeri, MD, Principal Investigator

Center for Cancer & Blood Disorders, Bethesda, Maryland 20817, United States; Completed

New York Hospital / Cornell University, Division of Pediatrics, New York, New York 10021, United States; Completed

Department of Pediatrics, SUNY at Stony Brook, Stony Brook, New York 11794-8111, United States; Completed

Oregon Health & Science University, Portland, Oregon 97239, United States; Completed

S.K. Soni Hospital Sect 5, Jaipur, Rajasthan 300201, India; Terminated

Instituto de Diagnóstico Hematológico Ambulatorio (IDHEA), Rosario, Sante Fe S2000JKR, Argentina; Recruiting
Jorgelina Safail, Phone: 0054 341 4205500, Email: jsafail@hotmail.com
Ider Cerutti, MD, Principal Investigator

Cancer Care Centers of South Texas, San Antonio, Texas 78229, United States; Completed

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Starting date: August 2007
Last updated: August 23, 2010