Trials / Completed
CompletedNCT03124368
A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3 Levels in Participants With C3G or IC-MPGN
A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Participants With Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 16 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study was to determine whether ACH-0144471 (also known as danicopan and ALXN2040) increases blood C3 complement protein (C3) levels in participants with low C3 levels due to either C3G or IC-MPGN.
Conditions
- C3 Glomerulonephritis
- Dense Deposit Disease
- C3 Glomerulopathy
- Immune Complex Mediated Membranoproliferative Glomerulonephritis
- Membranoproliferative Glomerulonephritis Types I, II, and III
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Danicopan | Participants received study drug for 14 days (Treatment Period), followed by a taper over the next 7 days (Taper Period). |
Timeline
- Start date
- 2017-08-09
- Primary completion
- 2018-12-21
- Completion
- 2019-01-09
- First posted
- 2017-04-21
- Last updated
- 2021-11-04
- Results posted
- 2021-07-13
Locations
3 sites across 3 countries: Australia, Belgium, Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03124368. Inclusion in this directory is not an endorsement.