Clinical Trials/NCT00004386

NCT00004386

Terminated

Phase 1

Phase I Pilot Study of Liver-Directed Gene Therapy for Partial Ornithine Transcarbamylase Deficiency

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)0 sitesOctober 1995

ConditionsOrnithine Transcarbamylase Deficiency Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Ornithine Transcarbamylase Deficiency Disease
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Status: Terminated
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

OBJECTIVES:

Evaluate the safety and feasibility of administering recombinant adenovirus containing the ornithine transcarbamylase gene to adults with partial ornithine transcarbamylase deficiency.

Detailed Description

PROTOCOL OUTLINE: This a dose escalation study to estimate the maximum tolerated dose of recombinant adenovirus encoded with the ornithine transcarbamylase gene. Patients receive a single dose of virus infused into the liver under fluoroscopic guidance. Groups of 3 patients receive successively higher doses of virus; each cohort is observed for safety for 3 weeks before entry of the next group. Patients are followed weekly for 1 month, then every 3 months until stable.

Registry

clinicaltrials.gov

Start Date

October 1995

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Not specified

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