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OPen Label Study to Evaluate Long Term Treatment Effect of DiaPep277

NCT01460251 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2015-03-19

No results posted yet for this study

Summary

The study is an open-label extension study, offering patients who participated and completed previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and clinical follow-up, for up to 3 additional years.The aim of the study is to collect safety and efficacy data of long term treatment effect of Diapep277.Only patients who completed studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L will be eligible for this extension study

Conditions

Interventions

DRUG

DiaPep277

1.0 mg DiaPep277® administered every 3 months.For patients who just completed the 2-year 901 study, a 3-year extended treatment will be offered with 13 administrations; patients who completed the 2-year 910 extension study will be offered a 3rd year of treatment with 5 additional administrations.

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Liat de Vries, Dr · Rabin Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • Israel

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 NCT01460251 on ClinicalTrials.gov