TP10 Use in Patients With C3 Glomerulopathy (C3G)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02302755|
Recruitment Status : Withdrawn (no recruitment)
First Posted : November 27, 2014
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dense Deposit Disease||Drug: TP10||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot, Open-Label Single Center Trial of TP10 in Pediatric and Adult Patients With C3 Glomerulopathy (C3G)|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: Screening/ Active Treatment Arm
Screening Period: This includes diagnosis confirmation, consent, required tests and vaccinations.
Treatment Period: All patients will be enrolled through the University of Iowa. This study will follow a patient-specific TP10 dose-escalation scheme during the Induction Period and subsequent dose adjustments based on complement levels during the Maintenance Period
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.
Other Name: sCR1
- C3 serum measurements, serum C3 breakdown products, and/or alternative pathway (AP) complement activity. [ Time Frame: 2 years ]
- Appropriate dose range and regimen for TP10. [ Time Frame: 2 years ]This will be based on biologic parameters including serum levels of C3 and C3 breakdown products, assays of alternative pathway activity, and dose-limiting toxicities.
- Immunogenicity of repeat TP10 administration. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302755
|United States, Iowa|
|University of Iowa Health Care|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Richard JH Smith, MD||University of Iowa|