Trials / Completed
CompletedNCT03369236
A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)
A Phase 2, Proof-of-Concept, Randomized, Double-Blinded, Placebo-Controlled Study of ACH-0144471 Treatment for 6 Months in Patients With C3 Glomerulopathy (C3G), With an Open-label Extension
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 17 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this proof-of-concept clinical study was to evaluate the efficacy and safety of the study drug, ACH-0144471 (also known as danicopan and ALXN2040), in participants with C3G who also had significant proteinuria attributable to C3G.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Danicopan | Danicopan was administered as an oral tablet. |
| DRUG | Placebo | Matching placebo was administered as an oral tablet. |
Timeline
- Start date
- 2018-06-12
- Primary completion
- 2019-12-11
- Completion
- 2020-12-18
- First posted
- 2017-12-11
- Last updated
- 2022-10-14
- Results posted
- 2021-11-04
Locations
7 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03369236. Inclusion in this directory is not an endorsement.