Recombinant Human C1 Inhibitor for the Treatment of Acute... | NCT00261053

Studies
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

NCT00261053

Sponsor

Pharming Technologies B.V.

Status

Completed

Last Update Posted

Apr 25, 2013Estimated

Enrollment

14Actual

Phase

Phase 2

Conditions

Genetic Disorders

Interventions

i.v. recombinant human C1 inhibitor

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Sep 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Dec 1, 2005

First Submission Date that Met QC Criteria

Dec 1, 2005

First Posted Date

Dec 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2013

Last Update Posted Date

Apr 25, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this single-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Open-label i.v. administration of 100 U/kg rhC1INH	Drug: i.v. recombinant human C1 inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
i.v. recombinant human C1 inhibitor	Drug		1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcomes: Relief of angioedema symptoms

Secondary Outcomes

Measure	Description	Time Frame
Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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
Participation in another clinical study within prior 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Nuijens, MD, PhD	Pharming Technologies B.V.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For information contact Sonja Visscher		Leiden		2333 CN	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D030342	Genetic Diseases, Inborn

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided