Recent Updates
Recently added Catalysts

IGIV3I Grifols

Phase 3

Immune (Idiopathic) Thrombocytopenic Purpura | Monoclonal antibody | Hematology |Grifols, S.A.|Last Updated: Feb 8, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

IGIV3I Grifols · 1 trial · 1 indication

Phase 3 1
NCT00699140Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic PurpuraImmune (Idiopathic) Thrombocytopenic Purpura
COMPLETED18 Analytics
PHASE3COMPLETED
Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura
Immune (Idiopathic) Thrombocytopenic Purpura
NCT0069914018
Unlock trial analytics

Study Endpoints

Primary Endpoints

Responder Patients
At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90).

The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10\^9/L.

Secondary Endpoints

Maximum Platelet Level Reached During the Follow-up Period
During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])
Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days)
At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])
Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days)
At any time during the study period (up to 3 months [90 days])
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1 treatment group with IGIV3I GrifolsEXPERIMENTALOpen label, non-randomized treatment group with IGIV3I Grifols Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.

Interventions

NameTypeDescription
IGIV3I GrifolsBIOLOGICALImmune Globulin Intravenous (Human)
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 82 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Be aged between 18 and 82 at the time of written consent. 2. Have confirmed diagnosis of chronic ITP and fulfil all the following criteria: * irrelevant history except for the symptoms of bleeding, * pattern of bleedings associated with platelet disorders, * physica...

Countries:RussiaSpainUnited Kingdom
Unlock Eligibility Criteria

Frequently asked questions about IGIV3I Grifols

What is IGIV3I Grifols used for?

IGIV3I Grifols is an investigational monoclonal antibody being developed for Immune (Idiopathic) Thrombocytopenic Purpura and Idiopathic Thrombocytopenic Purpura, conditions characterized by low platelet counts. It is in Phase 3 clinical development for these hematology indications.

Who makes IGIV3I Grifols?

IGIV3I Grifols is being developed by Grifols, S.A., a biopharmaceutical company traded under the ticker GRFS. The drug is currently in Phase 3 clinical trials for Immune (Idiopathic) Thrombocytopenic Purpura and Idiopathic Thrombocytopenic Purpura.

What phase is IGIV3I Grifols in?

IGIV3I Grifols is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials for the drug have been completed, with no active trials currently ongoing.

What clinical trials is IGIV3I Grifols in?

IGIV3I Grifols has completed two Phase 3 clinical trials. NCT00511147 enrolled 64 patients aged 3-70 with Idiopathic Thrombocytopenic Purpura across the United States, Canada, India, and Puerto Rico. NCT00699140 enrolled 18 patients with Immune Thrombocytopenic Purpura in Russia, Spain, and the United Kingdom.

What does IGIV3I Grifols target?

IGIV3I Grifols is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its effects in Immune (Idiopathic) Thrombocytopenic Purpura and Idiopathic Thrombocytopenic Purpura, conditions involving platelet destruction.