Last reviewed · How we verify
NCT03668288
Tolerance and Patients' Satisfaction With IGHy
trial testing Data record and questionnaires passation in Secondary or Primary Immunodeficiency in 20 participants. Status unknown.
14 August 2020
Quick facts
| Lead sponsor | CHU de Reims |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 14 February 2019 |
| Primary completion | 14 August 2020 |
| Estimated completion | 14 August 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- Data record and questionnaires passation
Conditions studied
- Secondary or Primary Immunodeficiency — all drugs for Secondary or Primary Immunodeficiency →
Sponsor
CHU de Reims — full company profile →
Who can join
18 and older, any sex, with Secondary or Primary Immunodeficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary immunodeficiencies (PID) represent more than 150 diseases affecting the immune system. More than 50% of PIDs are due to a lack or an insufficiency in antibody production. Some of these immunodeficiencies as well as some secondary immune deficiency with deficient antibody production (especially in hematology and oncology) are responsible for repeated and/or severe infections, requiring long-term replacement therapy with intravenous polyclonal immunoglobulin. Intravenous replacement therapy is administered every 21 or 28 days in hospital. Subcutaneous administration (weekly or bi-weekly) can be initiated for patients who cannot tolerate intravenous infusions or who have difficult venous access. However, some patients experience a decrease in quality of life with these more frequent administration at home. A new treatment is available in France since 2017, which is a subcutaneous infusion of human immunoglobulin facilitated by recombinant human hyaluronidase (IGHy), administered every 3 to 4 weeks in a single abdominal site, at home. No direct data are available in adults to evaluate tolerance and satisfaction with this treatment, but we know it is a preferred option in children and adolescents.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03668288
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03668288 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CHU de Reims
- Last refreshed: 4 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03668288.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing