A research study to determine if an experimental IVIG product, Gammaplex®, is safe, tolerable, and effective when given to patients who have Idiopathic Thrombocytopenic Purpura

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2011-005586-21-Outside-EU/EEA
• Date of registration: 07/12/2011
• Prospective Registration: Yes
• Primary sponsor: Bio Products Laboratory Limited
• Public title: A research study to determine if an experimental IVIG product, Gammaplex®, is safe, tolerable, and effective when given to patients who have Idiopathic Thrombocytopenic Purpura
• Scientific title: A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura - n/a
• Target sample size: 35
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005586-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Argentina, India, United States

Contacts

• Name: Regulatory Affairs
• Affiliation: Bio Products Laboratory Limited

• Name: Regulatory Affairs
• Affiliation: Bio Products Laboratory Limited

Key inclusion & exclusion 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 <=20x10^9/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 Day 1 infusion). 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 infusion on Day 1. 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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 3
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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 Day 1.
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) < 1x10^9/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 anaemic (haemoglobin <10 g/dL) at screening.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Idiopathic thrombocytopenic purpura.
MedDRA version: 14.0 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders

Intervention(s)

Trade Name: Gammaplex
Product Name: Gammaplex
Product Code: n/a
Pharmaceutical Form: Solution for injection
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: To determine GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50x10^9/L, similar to that of a historical control.

Primary end point(s): To determine GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50x10^9/L, similar to that of a historical control.

Secondary Objective: 1) to determine the safety of GAMMAPLEX at the dosage used in this study. 2) to determine if GAMMAPLEX maintains platelet counts of greater or equal to 50x10^9/L in subjects with chronic ITP for a period of time similar to that of a historical control.

Timepoint(s) of evaluation of this end point: Days 1, 2, 3, 5, 9, 14, 21, 32 and Day 90 (follow-up visit)

Secondary Outcome(s)

Secondary end point(s): 1) to determine the safety of GAMMAPLEX at the dosage used in this study. 2) to determine if GAMMAPLEX maintains platelet counts of greater than or equal to 50x10^9/L in subjects with chronic ITP for a period of time similar to that of a historical control.

Timepoint(s) of evaluation of this end point: Days 1, 2, 3, 5, 9, 14, 21, 32 and Day 90 (follow-up visit)

Secondary ID(s)

GMX02

CTRI/2010/091/000016

NCT00504075

Source(s) of Monetary Support

Bio Products Laboratory Limited