MedTrace Logo

Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®

NCT01898286 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-05-26

Study results available
· View outcomes & findings →

Summary

This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®.

Conditions

Interventions

DRUG

DiaPep277®

1 mg of DiaPep277® subcutaneously in the upper arm at 0, 3, 6, 9, 12, 15, 18, and 21 months, for a total of 8 administrations

Sponsors & Collaborators

  • Andromeda Biotech Ltd.

    lead INDUSTRY

Principal Investigators

  • Itamar Raz, MD · Hadassah Medical Center, Jerusalem

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
47 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01898286 on ClinicalTrials.gov