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NCT00870818TERMINATEDanonymous

An Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Patients With Recent-Onset Type 1 Diabetes Mellitus

Sponsor

Source record

MacroGenics

Phase

Source record

NA

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Type 1 Diabetes Mellitus

Indication / condition

AI-normalized

Type 1 Diabetes Mellitus

Intervention

Source record

Blood samples for safety, Patient reported outcome questionnaires, Analysis of T-cell subsets

Source & freshness

Source record

NCT ID

NCT00870818

Original source

ClinicalTrials.gov

Source last updated

Aug 09, 2023

Ingested at

May 31, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

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View original source fields

NCT ID

NCT00870818

Title

An Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Patients With Recent-Onset Type 1 Diabetes Mellitus

Sponsor

MacroGenics

Status

TERMINATED

Phase

NA

Condition raw

Type 1 Diabetes Mellitus

Condition normalized

Type 1 Diabetes Mellitus

Modality raw

Type 1 Diabetes Mellitus

Modality normalized

monoclonal antibody

Target raw

Type 1 Diabetes Mellitus

Target normalized

Type 1 Diabetes Mellitus

Interventions

Blood samples for safety, Patient reported outcome questionnaires, Analysis of T-cell subsets

Public preview

Source record

The study aimed to evaluate the long-term safety and efficacy of Teplizumab (MGA031), a monoclonal antibody, in patients with recent-onset Type 1 Diabetes Mellitus. The trial was sponsored by MacroGenics in collaboration with Eli Lilly and Company. It was terminated due to a business decision after enrolling 219 participants.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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