Penicillamine Chelation for Children With Lead Poisoning

NCT00552630 | Withdrawn Phase 2 DMC

• 2 other identifiers: 33611R01FD003361-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Childhood Lead Poisoning is a widespread disease that has few effective treatments. The specific aims of this proposed clinical trial are threefold:

• To determine whether a six-week course of a newly formulated d-penicillamine suspension will effectively reduce blood lead level in children aged 6 months to 16 years with blood lead levels of 15-25 μg/dL.
• To determine whether d-penicillamine chelation produces a sustained reduction in blood lead level in comparison with succimer and other lead chelators which always produce a significant post-treatment "rebound".
• To determine whether chelation with d-penicillamine improves the physiologic disturbances that can be measured in children with blood lead levels in this range.

Conditions

Lead Poisoning; Vitamin D Deficiency

Keywords

lead poisoning; chelation

Outcome Measures

Primary Outcomes (1)

• • To determine whether a six-week course of a newly formulated d-penicillamine suspension will effectively reduce blood lead level in children aged 6 months to 16 years with blood lead levels of 15-25 μg/dL.

  6 weeks

Secondary Outcomes (1)

• To determine whether d-penicillamine produces a sustained reduction in blood lead level and improves the physiologic disturbances that can be measured in children with blood lead levels in this range.

  10 weeks

Study Arms (2)

1

EXPERIMENTAL

This group will receive d-penicillamine for 6 weeks

Device: d-penicillamine

2

PLACEBO COMPARATOR

This group will receive placebo for 6 weeks

Drug: placebo

Interventions

d-penicillamine DEVICE

d-penicillamine twice daily, 15 mg/kg/day, for 6 weeks

1

placebo DRUG

placebo with same characteristics as drug

2

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Potential subjects will be children 6 months to 16 years of age with blood lead level 15-25 mcg/dL on two separate occasions separated by at least two weeks

You may not qualify if:

• allergic to d-penicillamine
• renal insufficiency
• taking immunosuppressive agents
• pre-existing idiopathic thrombocytopenia (platelet count \< 100,000/mm3) or leukopenia (WBC count \< 5,000/mm3 or polymorphonuclear leukocyte count \< 1000/mm3)
• blood lead level on the day of the initial clinic visit is below15 μg/dL or above 25 μg/dL
• blood lead level at the two-week follow up visit rises above 25 mcg/dL or falls below 15 mcg/dL
• currently undergoing chelation or have had chelation therapy in the previous two months

Sponsors & Collaborators

• FDA Office of Orphan Products Development: lead
• Bezoloven, Inc.: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lead Poisoning; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Heavy Metal Poisoning; Poisoning; Chemically-Induced Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Michael W Shannon, MD

  Boston Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: November 1, 2007
• First Posted: November 2, 2007
• Study Start: September 1, 2007
• Last Updated: March 26, 2015

Record last verified: 2007-12

Locations

US (1)