A Study to Evaluate the Benefit of RUCONEST® in Subjects Who Experience ADRs Related to IVIG Infusions
Completed · Phase 4
Conditions studied: CVI - Common Variable Immunodeficiency
In brief
Patients receiving intravenous immunoglobulin (IVIG) therapy for primary immunodeficiency and neurologic conditions may experience adverse drug reactions (ADRs). The mechanism of the ADR is unknown. Currently, the standard practice for these patients is to change from IV to subcutaneous IG (SCIG) but because of the need of immunomodulation or patient preference, SCIG may not be an option. Data has shown that some levels of complement decrease from pre- to post-infusion of IVIG. This study is to determine if replacing this complement protein may ameliorate ADRs.
Key facts
- Study ID
- NCT03576469
- Run by
- IMMUNOe Research Centers
- People needed
- 20
- Starts
- 2018-06-13
- Expected to finish
- 2020-03-01
- Last updated by the study team
- 2021-02-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years and older experiencing ADRs related to IVIG infusions
- Stable dose of IVIG for 3 months
- Willing to comply with all aspects of the protocol, including blood draws
- Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. Acceptable forms of contraception are defined as those with a failure rate < 1% when properly applied and include: a combination oral pill, some intra-uterine devices, and a sterilized partner in a stable relationship. Female patients must not be pregnant, planning to become pregnant, or be actively breastfeeding through the entire study period.
You may not qualify if…
- Receiving treatment for HAE, either prophylactic or acute therapy
- Patients with medical history of allergy to rabbits or rabbit-derived products (including rhC1INH)
- Patients who are pregnant, or breastfeeding, or are currently intending to become pregnant.
- Patients who, in the investigator's opinion, might not be suitable for the trial
Where it is running
- IMMUNOe Research Centers — Centennial, Colorado, United States
Full record on ClinicalTrials.gov
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