Recent Updates
Recently added Catalysts

i.v. recombinant human C1 inhibitor

Phase 2

Genetic Disorders | Small molecule | Rare Disease |Pharming Group N.V.|Last Updated: Apr 25, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials2
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

i.v. recombinant human C1 inhibitor · 2 trials · 1 indication

Phase 2 2
NCT00262288Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary AngioedemaGenetic Disorders
COMPLETED14 Analytics
NCT00261053Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary AngioedemaGenetic Disorders
COMPLETED14 Analytics
PHASE2COMPLETED
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Genetic DisordersUnlock trial analytics
PHASE2COMPLETED
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Genetic DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Primary outcomes: Relief of angioedema symptoms
24 hours

Secondary Endpoints

Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics
90 days
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Recombinant Human C1INHEXPERIMENTAL -
1OTHEROpen-label i.v. administration of 100 U/kg rhC1INH

Interventions

NameTypeDescription
i.v. recombinant human C1 inhibitorDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range16 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Main inclusion Criteria: * Clinical and laboratory diagnosis of HAE * Plasma level of functional C1INH of less than 50% of normal * Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE. Main exclusion Criteria: * Acquired angioedema * Pregnancy or breastfeeding ...

Countries:Netherlands
Unlock Eligibility Criteria

Frequently asked questions about i.v. recombinant human C1 inhibitor

What is i.v. recombinant human C1 inhibitor used for?

I.v. recombinant human C1 inhibitor is an investigational therapy being studied for the treatment of acute attacks in patients with hereditary angioedema, a genetic disorder. It is administered intravenously and is currently in Phase 2 clinical development.

Who makes i.v. recombinant human C1 inhibitor?

I.v. recombinant human C1 inhibitor is being developed by Pharming Group N.V., a biopharmaceutical company listed on the stock exchange under the ticker symbol PHAR.

What phase is i.v. recombinant human C1 inhibitor in?

I.v. recombinant human C1 inhibitor is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, but the drug remains in clinical development.

What clinical trials is i.v. recombinant human C1 inhibitor in?

I.v. recombinant human C1 inhibitor has been studied in two completed Phase 2 clinical trials: NCT00261053 and NCT00262288. Both trials evaluated the drug for the treatment of acute attacks in patients with hereditary angioedema and were conducted in the Netherlands.

Is i.v. recombinant human C1 inhibitor the same as recombinant human C1 esterase inhibitor?

I.v. recombinant human C1 inhibitor is a recombinant form of the human C1 inhibitor protein. It is designed to replace the deficient or dysfunctional C1 inhibitor in patients with hereditary angioedema, thereby helping to control acute attacks of the condition.