Safety, Tolerability and PK/PD Study in Young Adult Patie... | NCT00778518

Studies
Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

NCT00778518

Sponsor

Ambrx, Inc.

Status

Completed

Last Update Posted

Oct 12, 2009Estimated

Enrollment

36Estimated

Phase

Phase 2

Conditions

Growth Hormone Deficiency

Interventions

ARX201
ARX201
ARX201

Countries

Hungary

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

ID	Type	Description	Link
EudraCT: 2007-001746-40

Status Module

Record Verification Date

Oct 2009

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

Jul 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Oct 22, 2008

First Submission Date that Met QC Criteria

Oct 22, 2008

First Posted Date

Oct 23, 2008Estimated

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

Oct 9, 2009

Last Update Posted Date

Oct 12, 2009Estimated

Name	Class
Merck Serono International SA	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).

Detailed Description

The primary objective of this study is to evaluate the safety, tolerability and pharmacodynamic response of three different ARX201 doses (PEG-ahGH) when administered repeatedly to young adult patients with childhood onset growth hormone deficiency (GHD).

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

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	low dose	Drug: ARX201
2	Active Comparator	Medium dose	Drug: ARX201
3	Active Comparator	High Dose	Drug: ARX201

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARX201	Drug	Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Temporal profiling of circulating IGF-1 levels.		3 period

Secondary Outcomes

Measure	Description	Time Frame
Body composition measurements at start of study and end of study		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-30 years old
GHD of childhood onset
completed growth
IGF-1 <=2SDS
rhGH treatment naive
hGH levels below cut-off

Exclusion Criteria:

History of malignancy or intracranial tumors
ECG abnormality
ICH
hepatic dysfunction
renal impairment
major medical conditions
inadequate T4
positive for HBV, HCV, or HIV
alcohol or drug abuse

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mihaly Juhasz, MD	Accelsiors CRO & Consultancy Services	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Accelsiors CRO and Consultancy Services		Budapest			Hungary

Condition Browse Module

MeSH Terms

ID	Term
D004393	Dwarfism, Pituitary

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided