Clinical Trial: A Proof-of-Mechanism Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients With C3G or IC-MPGN
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients With Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproli
Brief Summary: The purpose of this study is to determine the effect of ACH-0144471 on C3 levels in patients with C3G or IC-MPGN.
Detailed Summary:
Sponsor: Achillion Pharmaceuticals
Current Primary Outcome: Change-from-baseline in C3 levels [ Time Frame: Day 21 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Serious Adverse Events (SAEs), Grade 3 or higher Adverse Events (AEs), and AEs leading to discontinuation [ Time Frame: Day 21 ]
- Time (in days) to achieving peak C3 levels from the first day of dosing [ Time Frame: Day 21 ]
- Profile of Pharmacokinetics: Area under the curve (AUC) [ Time Frame: Day 21 ]
- Profile of Pharmacokinetics: Maximum plasma concentration (Cmax) [ Time Frame: Day 21 ]
- Profile of Pharmacokinetics: Time to maximum concentration (Tmax) [ Time Frame: Day 21 ]
- Change in biomarkers of alternative pathway activity (AP) relative to baseline (AP Wieslab, factor D, and Bb) [ Time Frame: Day 21 ]
- Relationship between ACH-0144471 exposure and changes in C3 levels and other biomarkers of alternative pathway activity (AP Wieslab, factor D, and Bb) [ Time Frame: Day 21 ]
Original Secondary Outcome: Same as current
Information By: Achillion Pharmaceuticals
Dates:
Date Received: April 12, 2017
Date Started: May 2017
Date Completion: December 2018
Last Updated: April 19, 2017
Last Verified: April 2017
