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TP10 Use in Patients With C3 Glomerulopathy (C3G)

NCT02302755 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-10-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of repeated TP10 dosing in pediatric and adult patients with C3G and to evaluate the activity of TP10 in pediatric and adult patients with C3G, as measured by the proportion of patients with normalization of serum C3, serum C3 breakdown products, or alternative pathway (AP) complement activity.

Conditions

  • Dense Deposit Disease

Interventions

DRUG

TP10

All patients will be enrolled through the University of Iowa. This study will follow a patient-specific dose-escalation scheme during the Induction Period and subsequent TP10 dose adjustments based on complement levels during the Maintenance Period.

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Richard JH Smith, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302755 on ClinicalTrials.gov