Study of the Effects of XOMA 052 on Insulin Production in... | NCT00998699

Studies
Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes

NCT00998699

Sponsor

XOMA (US) LLC

Status

Completed

Last Update Posted

Mar 4, 2014Estimated

Enrollment

22Actual

Phase

Phase 2

Conditions

Type 1 Diabetes

Interventions

Xoma 052
Placebo

Countries

Switzerland

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

Mar 2014

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

Feb 2010

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Oct 19, 2009

First Submission Date that Met QC Criteria

Oct 19, 2009

First Posted Date

Oct 20, 2009Estimated

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

Mar 3, 2014

Last Update Posted Date

Mar 4, 2014Estimated

Name	Class
Juvenile Diabetes Research Foundation	OTHER

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 study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell regeneration.

The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and insulin production.

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

22Actual

Label	Type	Description	Intervention Names
XOMA 052	Active Comparator		Drug: Xoma 052
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Xoma 052	Drug	Sterile solution subcutaneously administered every 4 weeks for 12 weeks	XOMA 052

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in beta-cell function as measured by change in C-peptide level during thd MMTT (Mixed meal tolerance test) at Day 112 compared to baseline (Day 0 pre-dose)		Day 0 pre-dose and Day 112

Secondary Outcomes

Measure	Description	Time Frame
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.		Day 0 (baseline) through Day 364
Change in insulin requirements		Day -3 through Day 0 pre-dose and Day 109 through Day 112)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Stable Type 1 diabetes of > 2 year duration
No clinically significant change in treatment regimen for T1D
Age ≥ 18 years and ≤ 55 years
HbA1c < 7.0%
Positive GAD65 and/or IA-2 auto-antibodies
Peak C-peptide > 100 pM following IV injection of 1 mg glucagon
Body-mass index (BMI) > 18 and < 28 kg/m2
Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study

Exclusion criteria:

Current infection or history of infection
Positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV
History of tuberculosis or positive PPD test
Presence of foot, leg, or decubitus ulcers
Current immunosuppressive treatment or documented immunodeficiency
History of severe allergic or anaphylactic reactions
History of asthma requiring systemic corticosteroid therapy
Coronary intervention (PCI, stent placement) or hospitalization for cardiovascular condition within the last 12 months
Uncontrolled hypertension
History of congestive heart failure (NYHA Class III or IV)
History of a coronary event within the last 12 months
Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
History of malignancy within the last 5 years
Receipt of a live (attenuated) vaccine within the last 3 months

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Marc Donath, MD	UniversitaetsSpital Zuerich	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Basel			Switzerland