NCT02685137 is a Phase 3 clinical trial of stannsoporfin in Nutritional and Metabolic Diseases, sponsored by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company.

Who is sponsoring NCT02685137?

NCT02685137 is sponsored by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company.

What drugs are being tested in NCT02685137?

Interventions in NCT02685137: stannsoporfin, Sham Injection.

What condition does NCT02685137 study?

NCT02685137 studies Nutritional and Metabolic Diseases.

Is NCT02685137 still recruiting?

NCT02685137 is currently completed. Last updated 25 October 2019.

Last reviewed 2019-10-25 · How we verify

NCT02685137

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter Study to Evaluate the Efficacy and Safety of Tin Mesoporphyrin (Stannsoporfin) to Reduce the Need for Phototherapy in Term and Near Term Infants.

Completed Phase 3 Last updated 25 October 2019

What this trial tests

Phase 3 trial testing stannsoporfin in Nutritional and Metabolic Diseases in 185 participants. Completed in 1 February 2013.

Timeline

1 May 2002

Primary endpoint
16 March 2003

1 February 2013

Quick facts

Lead sponsor	InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	185
Start date	1 May 2002
Primary completion	16 March 2003
Estimated completion	1 February 2013
Sites	1 location across United States

Drugs / interventions tested

stannsoporfin — full drug profile →
Sham Injection — full drug profile →

Conditions studied

Nutritional and Metabolic Diseases — all drugs for Nutritional and Metabolic Diseases →

Sponsor

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company — full company profile →

Who can join

Adults 12 Hours to 36 Hours, any sex, with Nutritional and Metabolic Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Need for Phototherapy
Time frame: 30 days
proportion of cases which need phototherapy in the treated population

Sponsor's own description

This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the well-baby nursery and enrolled with "intention to treat".

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

An oral heme oxygenase inhibitor targets immunosuppressive perivascular macrophages in preclinical models of cancer.
Bahri M, Al-Adhami T, Demirel E, Sarkar J, et al · · 2025 · cited 3× · PMID 40768602 · DOI 10.1126/scitranslmed.ads3085

Verify or expand the search:

Other recruiting trials for Nutritional and Metabolic Diseases

Currently open trials in the same condition.

NCT06482944 — Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes · NA · recruiting
NCT06386471 — Personalized GI Motility Responses to Diet · NA · recruiting
NCT06127823 — Effect of Intensive Nutrition Training, Education, and Support in Gestational Diabetes - The INTENSE-GDM TRIAL · NA · active not recruiting
NCT05723913 — Postprandial Glucose Levels, Gut Microbiota and Supplementation With Functional Foods in Adults · NA · recruiting
NCT05484999 — The Maternal Well-Being Study · NA · active not recruiting

Other InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company trials

Trials by the same sponsor.

NCT02000830 — Follow up Study of Patients Having Participated in Clinical Trial 64,185-204 · completed
NCT01887327 — Stannsoporfin With Light Therapy for Newborn Babies With Jaundice · Phase 2 · completed
NCT02033096 — Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993) · completed
NCT00076960 — Compassionate Use of Stanate (TM) [Stannsoporfin] · no longer available

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02685137 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Last refreshed: 25 October 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02685137.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing