Recent Updates
Recently added Catalysts

Recombinant human hyaluronidase+ immune globulin

Phase 3

Primary Immunodeficiency Diseases (PID) | Monoclonal antibody | Immunology |Takeda Pharmaceutical Company Limited|Last Updated: May 19, 2021

Target and mechanism

ModalityMonoclonal antibody

Also known as Recombinant human hyaluronidase

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials2
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Recombinant human hyaluronidase+ immune globulin · 2 trials · 1 indication

Phase 3 1Phase 1 1
NCT00814320Gammagard Liquid and rHuPH20 in PIDPrimary Immunodeficiency Diseases (PID)
COMPLETED89 Analytics
PHASE3COMPLETED
Gammagard Liquid and rHuPH20 in PID
Primary Immunodeficiency Diseases (PID)
NCT0081432089
Unlock trial analytics

Study Endpoints

Primary Endpoints

Validated Acute Serious Bacterial Infection (VASBI) Rate
Throughout the study period (17 months)

Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen. VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only. The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant.

Ability to administer, after priming with recombinant human hyaluronidase, at least one half of a 4-week dose (minimum of 200 mg/kg) of IgG in a single infusion site, via the subcutaneous route, with no more than mild local adverse drug reactions.
72 hours

Secondary Endpoints

Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years
PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years
IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit
Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20
PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf.
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALEfficacy and tolerability of subcutaneous (SC) infusions of immune globulin intravenous (IGIV), 10% with hyaluronidase (rHuPH20) after ramp-up
2EXPERIMENTALPharmacokinetics of intravenous (IV) infusions of immune globulin intravenous (IGIV), 10% and efficacy and tolerability of subcutaneous (SC) infusions of immune globulin intravenous (IGIV), 10% with hyaluronidase (rHuPH20) after ramp-up

Interventions

NameTypeDescription
Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)BIOLOGICALComprises subjects previously participating in Study 160601, who now only complete Study Epoch 2 (subcutaneous \[SC\] infusions) as bioavailability/exposure for intravenous (IV) treatment was already obtained in Study 160601. Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up).
Recombinant human hyaluronidase + immune globulin intravenousBIOLOGICALDose (calculated) of rHuPH20 followed by subcutaneous infusion of IGIV, 10% to determine tolerability: doses of rHuPH20 and IGIV, 10% to be increased, as tolerated and as per protocol, until a full 4-week IgG dose can be administered
Unlock Study Design Details

Eligibility Criteria

Age Range2 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Participant is 2 years or older at the time of screening * Written informed consent obtained from either the participant or the participant's legally acceptable representative prior to any study-related procedures and study product administration * Participant has been diagnos...

Countries:United StatesCanada
Unlock Eligibility Criteria