NCT00004402COMPLETEDanonymous

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

Sponsor

Source record

FDA Office of Orphan Products Development

Phase

Source record

PHASE3

Modality

AI-normalized

small molecule

Target

AI-normalized

calcitriol, interferon gamma

Indication / condition

AI-normalized

Osteopetrosis

Intervention

Source record

calcitriol, interferon gamma

Related intelligence directories

Indication directory: Osteopetrosis Modality directory: small molecule Target directory: calcitriol

Source & freshness

Source record

NCT ID

NCT00004402

Original source

ClinicalTrials.gov

Source last updated

Mar 25, 2015

Ingested at

Jun 19, 2026

Internal sync

Jun 19, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT00004402

Title

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

Sponsor

FDA Office of Orphan Products Development

Status

COMPLETED

Phase

PHASE3

Condition raw

Osteopetrosis

Condition normalized

Osteopetrosis

Modality raw

small molecule

Modality normalized

small molecule

Target raw

calcitriol, interferon gamma

Target normalized

calcitriol, interferon gamma

Interventions

calcitriol, interferon gamma

Public preview

Source record

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.

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Investment-Ready Snapshot

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.

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

Source & freshness

Public preview

Create an account to unlock this report

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

Investment-Ready Snapshot

Provenance

Protocol Description

Outcome Measures

Eligibility

Known Results And Readout Context

Patent And IP Landscape

Contacts