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ACTIMMUNE in Intermediate Osteopetrosis

NCT02666768 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-10-22

Study results available
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Summary

This study evaluates the effects of ACTIMMUNE (IFN-γ1b) in children and adults with intermediate osteoporosis. All participants will receive treatment with ACTIMMUNE for 12 months. The investigators hypothesize that ACTIMMUNE will be tolerated by participants for the full 12 months and result in decreased disease severity.

Conditions

  • Osteopetrosis

Interventions

DRUG

Interferon gamma-1b

gamma interferon-1b dose escalation over first 4 weeks of study to 100 mcg SC 3 times weekly

Sponsors & Collaborators

  • University of Minnesota

    collaborator OTHER

  • Horizon Pharma Ireland, Ltd., Dublin Ireland

    collaborator INDUSTRY

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    lead OTHER

Principal Investigators

  • Lynda E Polgreen, MD, MS · Los Angeles BioMedical Research Center at Harbor-UCLA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-22
Primary Completion
2019-03-11
Completion
2019-04-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02666768 on ClinicalTrials.gov