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Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis

NCT00004402 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-03-25

No results posted yet for this study

Summary

OBJECTIVES: I. Compare the rate of treatment failure in osteopetrosis patients receiving interferon gamma in combination with calcitriol to the rate of treatment failure in patients receiving calcitriol alone.

II. Compare the number of adverse events or clinical manifestations of disease progression occurring in these patients.

III. Assess the effects of interferon gamma on hematopoiesis, cranial nerve function, and rate of infection in these patients.

Conditions

  • Osteopetrosis

Interventions

DRUG

calcitriol

DRUG

interferon gamma

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • FDA Office of Orphan Products Development

    lead FED

Principal Investigators

  • L. Lyndon Key, Jr. · Medical University of South Carolina

Study Design

Purpose
TREATMENT

Eligibility

Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-11-30
Completion
2000-06-30

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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 NCT00004402 on ClinicalTrials.gov